Bariatric Surgery Candidate
Conditions
Keywords
Bariatric surgery, Bariatrics, Local anesthetic, Ropivacaine, Intraperitoneal
Brief summary
This is a pilot study in a randomized, controlled, double-blinded format and will evaluate the ability of a local anesthetic, Ropivacaine, to decrease pain after gastric bypass surgery. The drug will be administered into the abdomen during a bariatric bypass surgery. After surgery, patients who received Ropivacaine will be compared to those without Ropivacaine to determine its effect on reducing pain, recovery of lung function, ability to walk, and quality of life during recovery.
Detailed description
Introduction: Postoperative pain control remains a major challenge for surgical procedures, including laparoscopic gastric bypass. Pain management is particularly relevant in obese patients who experience a higher number of of cardiovascular and pulmonary events. effective pain management may reduce their risk of serious postoperative complications, such as deep venous thrombosis and pulmonary emboli. The objective of this study is to evaluate the efficacy of intraperitoneal local anaesthetic, ropivacaine, to reduce postoperative pain in patients undergoing laparoscopic Roux-en-Y gastric bypass. Methods and Analysis: A randomized controlled trial will be conducted to compare intraperitoneal ropivacaine (Intervention) versus normal saline (placebo) in 120 adult patients undergoing bariatric surgery. Ropivacaine will be infused over the oesophageal hiatus and throughout the abdomen. Patients in the control arm will undergo the same treatment as normal saline. The primary end point will be postoperative pain at 1, 2 and 4 hours postoperatively. Pain measurements will then occur every 4 hours for 24 h and every 8h until discharge. Secondary endpoints will include opioid use, peak expiratory flow, 6 min walk distance and quality of life. Intention-to-treat analysis will be used and repeated measures will be analysed using mixed model approach. post-hoc pairwise comparison of the treatment groups at different time points will be carried out using multiple comparisons with adjustments to the type 1 error. Results of the study will inform the feasibility of effectiveness of intraperitoneal ropivacaine. Ethics and dissemination This study has been approved by the Ottawa Health Science Network Research Ethics Board and Health Canada in April 2014. The findings of the study will be disseminated through national and international conferences and peer-reviewed journals.
Interventions
DRUGRopivacaine
DRUGNormal Saline
Sponsors
Ottawa Hospital Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients undergoing Roux-en-Y gastric bypass surgery; * Patients who able to tolerate general anesthetic and pneumoperitoneum; * Patients who able to provide informed consent for the surgery; * Patients over the age of 18 years;
Exclusion criteria
* Patient undergoing planned Sleeve Gastrectomy (inta-op conversion to Sleeve Gastrectomy after delivery of intraperitoneal ropivacaine will be included and analyzed using intention-to-treat approach) * Patients with an allergy to local anesthetics * Patients with severe underlying cardiovascular disease (ie: congestive heart failure, conduction abnormalities, and ischemic heart disease) * Patients with chronic renal disease Stage 3 or greater (Creatinine clearance less than 60mL/hr (millilitre per hour)) * Patients with hepatic dysfunction Child-Pugh Class B or C * Patients with previous foregut surgery including esophageal, gastric, liver, and pancreas resections
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 0-1 h Postoperative Pain Level | 0-1 hours post operatively | Measured by the Numeric Pain Rating Scale (NRS) with a range of 0-10 where 0 represents No pain at all ( best outcome) and 10 represents Worst possible pain (worst outcome). |
| 1-2 h Postoperative Pain Level | 1-2 hours post operatively | Measured by the Numeric Pain Rating Scale (NRS) with a range of 0-10 where 0 represents No pain at all ( best outcome) and 10 represents Worst possible pain (worst outcome). |
| 2-4 Hours Post Operative Pain Level | 2-4 hours post operatively | Measured by the Numeric Pain Rating Scale (NRS) with a range of 0-10 where 0 represents No pain at all ( best outcome) and 10 represents Worst possible pain (worst outcome). |
| 4-8 Hours Post Operative Pain Level | 4-8 hours post operatively | Measured by the Numeric Pain Rating Scale (NRS) with a range of 0-10 where 0 represents No pain at all ( best outcome) and 10 represents Worst possible pain (worst outcome). |
| 8-12 Hours Post Operative Pain Level | 8-12 hours post operatively | Measured by the Numeric Pain Rating Scale (NRS) with a range of 0-10 where 0 represents No pain at all ( best outcome) and 10 represents Worst possible pain (worst outcome). |
| 12-16 Hours Post Operative Pain Level | 12-16 hours post operatively | Measured by the Numeric Pain Rating Scale (NRS) with a range of 0-10 where 0 represents No pain at all ( best outcome) and 10 represents Worst possible pain (worst outcome). |
| 16-20 Hours Post Operative Pain Level | 16-20 hours post operatively | Measured by the Numeric Pain Rating Scale (NRS) with a range of 0-10 where 0 represents No pain at all ( best outcome) and 10 represents Worst possible pain (worst outcome). |
| 20-24 Hours Post Operative Pain Level | 20-24 hours post operatively | Measured by the Numeric Pain Rating Scale (NRS) with a range of 0-10 where 0 represents No pain at all ( best outcome) and 10 represents Worst possible pain (worst outcome). |
| 24-32 Hours Post Operative Pain Level | 24-32 hours post operatively | Measured by the Numeric Pain Rating Scale (NRS) with a range of 0-10 where 0 represents No pain at all ( best outcome) and 10 represents Worst possible pain (worst outcome). |
| 32-40 Hours Post Operative Pain Level | 32-40 hours post operatively | Measured by the Numeric Pain Rating Scale (NRS) with a range of 0-10 where 0 represents No pain at all ( best outcome) and 10 represents Worst possible pain (worst outcome). |
| 40-48 Hours Post Operative Pain Level | 40-48 hours post operatively | Measured by the Numeric Pain Rating Scale (NRS) with a range of 0-10 where 0 represents No pain at all ( best outcome) and 10 represents Worst possible pain (worst outcome). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 40h Peak Expiratory Flow (PEF) Score | 40 hours post operatively | Measured using the Mini Wright Peak flow meter with a range of 60-800 L/Min where 60 L/Min represents the worst possible score and 800 L/Min represents the best possible score. Value recorded is based on an average of 3 readings at every time point. |
| 48h Peak Expiratory Flow (PEF) Score | 48 hours post operatively | Measured using the Mini Wright Peak flow meter with a range of 60-800 L/Min where 60 L/Min represents the worst possible score and 800 L/Min represents the best possible score. Value recorded is based on an average of 3 readings at every time point. |
| 6 Minute Walking Distance Post Operative Day 1 (POD1) | Post operative day 1 | 6-Minute walk distance (6MWD)-Defined as the distance in (m) an individual is able to walk a long a flat 30 m walkway over six--minute period, with breaks as required. walk testing has been validated in the obese population, clinically significant differences occur when distances of at least 80m occur. 0 m would be the worst possible value for this outcome and the higher the number achieved in the six-minute duration the better (Better outcome) |
| 6 Minute Walking Distance Post Operative Day 2 (POD2) | Post operative day 2 | 6-Minute walk distance (6MWD)-Defined as the distance in (m) an individual is able to walk a long a flat 30 m walkway over six--minute period, with breaks as required. walk testing has been validated in the obese population, clinically significant differences occur when distances of at least 80m occur. 0 m would be the worst possible value for this outcome and the higher the number achieved in the six-minute duration the better (Better outcome) |
| Postoperative Day 1 Quality of Recovery Questionnaire (QR-40) | Post operative day 1 | 40-item questionnaire provides a global score(Minimum-score 40, Maximum-Score 200, Higher score represent better Quality of recovery of participant in both global and subscores) subscores(summed to total the global score) across five dimensions explained below, in all categories minimum score is 1, maximum score of 5 for each question.unit is scores on a scale for all questions. Emotional\_State:9 questions subscore can range between 9-45 Physical\_Comfort:12 questions, subscore range between 12-60 Psychological Support:7 questions, subscore range between 7-35 Physical\_Independence:5 questions, subscore range between 5-25 Pain:7 questions, subscore range between 5-25 Questionnaire has two parts A and B, In part A, a score of 1 represents the answer of None of the time (Poor)and 5 represents the answerAll of the time (Excellent)Part B, score of 1 represents the answerAll of the time (Excellent) and 5 representsNone of the time (Poor) |
| 0-1 h Postoperative Tylenol Consumption | 0-1 hours post operatively | The amount in mg of Tylenol administered to the patient |
| 0-1 h Postoperative Ketorolac Consumption | 0-1 hours post operatively | The amount in mg of Ketorolac administered to patient |
| 0-1 h Postoperative Dilaudid Consumption | 0-1 hours post operatively | The amount in mg of Dilaudid administered to patient |
| 0-1 h Postoperative Tramadol Consumption | 0-1 h Postoperative Tramadol consumption | The amount in mg of Tramadol administered to patient |
| 0-1 h Postoperative Fentanyl Consumption | 0-1 hours post operatively | The amount in mcg of Fentanyl administered to patient |
| 1-2 h Postoperative Tylenol Consumption | 1-2 hours post operatively | The amount in mg of Tylenol administered to patient |
| 1-2 h Postoperative Ketorolac Consumption | 1-2 hours post operatively | The amount in mg of Ketorolac administered to patient |
| 1-2 h Postoperative Dilaudid Consumption | 1-2 hours post operatively | The amount in mg of Dilaudid administered to patient |
| 1-2 h Postoperative Tramadol Consumption | 1-2 hours post operatively | The amount in mg of Tramadol administered to patient |
| 1-2 h Postoperative Fentanyl Consumption | 1-2 hours post operatively | The amount in mcg of Fentanyl administered to patient |
| 2-4 h Postoperative Tylenol Consumption | 2-4 hours post operatively | The amount in mg of Tylenol administered to patient |
| 2-4 h Postoperative Tramadol Consumption | 2-4 hours post operatively | The amount in mg of Tramadol administered to patient |
| 2-4 h Postoperative Fentanyl Consumption | 2-4 hours post operatively | The amount in mcg of Fentanyl administered to patient |
| 4-12 h Postoperative Tylenol Consumption | 4-12 hours post operatively | The amount in mg of Tylenol administered to patient |
| 4-12 h Postoperative Ketorolac Consumption | 4-12 hours post operatively | The amount in mg of Ketorolac administered to patient |
| 4-12 h Postoperative Tramadol Consumption | 4-12 hours post operatively | The amount in mg of Tramadol administered to patient |
| 4-12 h Postoperative Dilaudid Consumption | 4-12 hours post operatively | The amount in mg of Dilaudid administered to patient |
| 2-4 h Postoperative Ketorolac Consumption | 2-4 hours post operatively | The amount in mg of Ketorolac administered to patient |
| 12-24 h Postoperative Ketorolac Consumption | 12-24 hours post operatively | The amount in mg of Ketorolac administered to patient |
| 12-24 h Postoperative Tramadol Consumption | 12-24 hours post operatively | The amount in mg of Tramadol administered to patient |
| 12-24 h Postoperative Dilaudid Consumption | 12-24 hours post operatively | The amount in mg of Dilaudid administered to patient |
| 24-48 h Postoperative Tylenol Consumption | 24-48 hours post operatively | The amount in mg of Tylenol administered to patient |
| 24-48 h Postoperative Ketorolac Consumption | 24-48 hours post operatively | The amount in mg of Ketorolac administered to patient |
| 24-48 h Postoperative Tramadol Consumption | 24-48 hours post operatively | The amount in mg of Tramadol administered to patient |
| 24-48 h Postoperative Dilaudid Consumption | 24-48 hours post operatively | The amount in mg of Dilaudid administered to patient |
| Postoperative Day 7-10 Quality of Recovery Questionnaire (QR-40) | Post operative day 7-10 | 40-item questionnaire provides a global score(Minimum-score 40,Maximum-Score 200, Higher score represent better Quality of recovery of participant in both global and subscores) subscores(summed to total the global score) across five dimensions explained below, in all categories minimum score is 1,maximum score of 5 for each question.unit is scores on a scale for all questions. Emotional\_State:9 questions subscore can range between 9-45 Physical\_Comfort:12 questions, subscore range between 12-60 Psychological Support:7 questions, subscore range between 7-35 Physical\_Independence:5 questions, subscore range between 5-25 Pain:7 questions,subscore range between 5-25 Questionnaire has two parts A and B, In part A, a score of 1 represents the answer of None of the time (Poor)and 5 represents the answerAll of the time (Excellent)Part B, score of 1 represents the answerAll of the time (Excellent) and 5 representsNone of the time (Poor) |
| 6 Minute Walking Distance Post Operative Day 7-10 (POD 7-10) | Post operative day 7-10 (Follow-up Clinic) | 6-Minute walk distance (6MWD)-Defined as the distance in (m) an individual is able to walk a long a flat 30 m walkway over six--minute period, with breaks as required. walk testing has been validated in the obese population, clinically significant differences occur when distances of at least 80m occur. 0 m would be the worst possible value for this outcome and the higher the number achieved in the six-minute duration the better (Better outcome) |
| 12-24 h Postoperative Tylenol Consumption | 12-24 hours post operatively | The amount in mg of Tylenol administered to patient |
| 1h Peak Expiratory Flow (PEF) Score | 1 hours post operatively | Measured using the Mini Wright Peak flow meter with a range of 60-800 L/Min where 60 L/Min represents the worst possible score and 800 L/Min represents the best possible score. Value recorded is based on an average of 3 readings at every time point. |
| 2h Peak Expiratory Flow (PEF) Score | 2 hours post operatively | Measured using the Mini Wright Peak flow meter with a range of 60-800 L/Min where 60 L/Min represents the worst possible score and 800 L/Min represents the best possible score. Value recorded is based on an average of 3 readings at every time point. |
| 4h Peak Expiratory Flow (PEF) Score | 4 hours post operatively | Measured using the Mini Wright Peak flow meter with a range of 60-800 L/Min where 60 L/Min represents the worst possible score and 800 L/Min represents the best possible score. Value recorded is based on an average of 3 readings at every time point. |
| 2-4 h Postoperative Dilaudid Consumption | 2-4 hours post operatively | The amount in mg of Dilaudid administered to patient |
| 8h Peak Expiratory Flow (PEF) Score | 8 hours post operatively | Measured using the Mini Wright Peak flow meter with a range of 60-800 L/Min where 60 L/Min represents the worst possible score and 800 L/Min represents the best possible score. Value recorded is based on an average of 3 readings at every time point. |
| 12h Peak Expiratory Flow (PEF) Score | 12 hours post operatively | Measured using the Mini Wright Peak flow meter with a range of 60-800 L/Min where 60 L/Min represents the worst possible score and 800 L/Min represents the best possible score. Value recorded is based on an average of 3 readings at every time point. |
| 16h Peak Expiratory Flow (PEF) Score | 16 hours post operatively | Measured using the Mini Wright Peak flow meter with a range of 60-800 L/Min where 60 L/Min represents the worst possible score and 800 L/Min represents the best possible score. Value recorded is based on an average of 3 readings at every time point. |
| 20h Peak Expiratory Flow (PEF) Score | 20 hours post operatively | Measured using the Mini Wright Peak flow meter with a range of 60-800 L/Min where 60 L/Min represents the worst possible score and 800 L/Min represents the best possible score. Value recorded is based on an average of 3 readings at every time point. |
| 24h Peak Expiratory Flow (PEF) Score | 24 hours post operatively | Measured using the Mini Wright Peak flow meter with a range of 60-800 L/Min where 60 L/Min represents the worst possible score and 800 L/Min represents the best possible score. Value recorded is based on an average of 3 readings at every time point. |
| 32h Peak Expiratory Flow (PEF) Score | 32 hours post operatively | Measured using the Mini Wright Peak flow meter with a range of 60-800 L/Min where 60 L/Min represents the worst possible score and 800 L/Min represents the best possible score. Value recorded is based on an average of 3 readings at every time point. |
Countries
Canada
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Intraperitoneal Normal Saline Intraperitoneal Normal Saline: 100mL normal saline administered as in intervention arm prior to dissection. | 46 |
| Intraperitoneal Ropivacaine 200mg of Ropivacaine (0.2% Ropivacaine in 100mL Normal Saline) prior to dissection. | 46 |
| Total | 92 |
Baseline characteristics
| Characteristic | Intraperitoneal Normal Saline | Total | Intraperitoneal Ropivacaine |
|---|---|---|---|
| Age, Continuous | 45.1 Years STANDARD_DEVIATION 9.44 | 44.75 Years STANDARD_DEVIATION 9.43 | 44.4 Years STANDARD_DEVIATION 9.42 |
| History of Arthritis | 22 participants | 44 participants | 22 participants |
| History of Asthma | 6 Participants | 20 Participants | 14 Participants |
| History of Cardiovascular Disease | 24 participants | 39 participants | 15 participants |
| History of Pain Syndromes | 9 Participants | 11 Participants | 2 Participants |
| Mean BMI | 45.82 kg/m^2 STANDARD_DEVIATION 6.57 | 47.195 kg/m^2 STANDARD_DEVIATION 6.32 | 48.57 kg/m^2 STANDARD_DEVIATION 6.07 |
| On Diabetic Medications | 18 participants | 30 participants | 12 participants |
| On Pain Medications | 22 participants | 42 participants | 20 participants |
| Previous Caesarean section | 12 participants | 21 participants | 9 participants |
| Previous Laparoscopic Cholecystectomy | 9 participants | 22 participants | 13 participants |
| Prior Surgery | 44 participants | 88 participants | 44 participants |
| Region of Enrollment Canada | 46 Participants | 92 Participants | 46 Participants |
| Sex: Female, Male Female | 39 Participants | 77 Participants | 38 Participants |
| Sex: Female, Male Male | 7 Participants | 15 Participants | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 46 | 0 / 46 |
| serious Total, serious adverse events | 0 / 46 | 0 / 46 |
Outcome results
Primary
0-1 h Postoperative Pain Level
Measured by the Numeric Pain Rating Scale (NRS) with a range of 0-10 where 0 represents No pain at all ( best outcome) and 10 represents Worst possible pain (worst outcome).
Time frame: 0-1 hours post operatively
Population: Overall Number of Participants Analyzed is not consistent with numbers provided Participant Flow module due to patients refusing or being unable to provide the reading for outcome during the allocated time frame which could vary the number of results obtained in a specific time frame.~The analysis was done and revised by our Statistician
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intraperitoneal Normal Saline | 0-1 h Postoperative Pain Level | 3.9762 units on a scale | Standard Deviation 2.5191 |
| Intraperitoneal Ropivacaine | 0-1 h Postoperative Pain Level | 4.3149 units on a scale | Standard Deviation 2.1074 |
Primary
12-16 Hours Post Operative Pain Level
Measured by the Numeric Pain Rating Scale (NRS) with a range of 0-10 where 0 represents No pain at all ( best outcome) and 10 represents Worst possible pain (worst outcome).
Time frame: 12-16 hours post operatively
Population: Overall Number of Participants Analyzed is not consistent with numbers provided Participant Flow module due to patients refusing or being unable to provide the reading for outcome during the allocated time frame which could vary the number of results obtained in a specific time frame.~The analysis was done and revised by our Statistician
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intraperitoneal Normal Saline | 12-16 Hours Post Operative Pain Level | 3.4419 units on a scale | Standard Deviation 2.2152 |
| Intraperitoneal Ropivacaine | 12-16 Hours Post Operative Pain Level | 3.9444 units on a scale | Standard Deviation 1.9283 |
Primary
1-2 h Postoperative Pain Level
Measured by the Numeric Pain Rating Scale (NRS) with a range of 0-10 where 0 represents No pain at all ( best outcome) and 10 represents Worst possible pain (worst outcome).
Time frame: 1-2 hours post operatively
Population: Overall Number of Participants Analyzed is not consistent with numbers provided Participant Flow module due to patients refusing or being unable to provide the reading for outcome during the allocated time frame which could vary the number of results obtained in a specific time frame.~The analysis was done and revised by our Statistician
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intraperitoneal Normal Saline | 1-2 h Postoperative Pain Level | 3.5307 units on a scale | Standard Deviation 1.6086 |
| Intraperitoneal Ropivacaine | 1-2 h Postoperative Pain Level | 3.6911 units on a scale | Standard Deviation 1.522 |
Primary
16-20 Hours Post Operative Pain Level
Measured by the Numeric Pain Rating Scale (NRS) with a range of 0-10 where 0 represents No pain at all ( best outcome) and 10 represents Worst possible pain (worst outcome).
Time frame: 16-20 hours post operatively
Population: Overall Number of Participants Analyzed is not consistent with numbers provided Participant Flow module due to patients refusing or being unable to provide the reading for outcome during the allocated time frame which could vary the number of results obtained in a specific time frame.~The analysis was done and revised by our Statistician
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intraperitoneal Normal Saline | 16-20 Hours Post Operative Pain Level | 3.4186 units on a scale | Standard Deviation 1.899 |
| Intraperitoneal Ropivacaine | 16-20 Hours Post Operative Pain Level | 3.8081 units on a scale | Standard Deviation 1.6071 |
Primary
20-24 Hours Post Operative Pain Level
Measured by the Numeric Pain Rating Scale (NRS) with a range of 0-10 where 0 represents No pain at all ( best outcome) and 10 represents Worst possible pain (worst outcome).
Time frame: 20-24 hours post operatively
Population: Overall Number of Participants Analyzed is not consistent with numbers provided Participant Flow module due to patients refusing or being unable to provide the reading for outcome during the allocated time frame which could vary the number of results obtained in a specific time frame.~The analysis was done and revised by our Statistician
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intraperitoneal Normal Saline | 20-24 Hours Post Operative Pain Level | 3.2386 units on a scale | Standard Deviation 1.6548 |
| Intraperitoneal Ropivacaine | 20-24 Hours Post Operative Pain Level | 3.4651 units on a scale | Standard Deviation 1.5976 |
Primary
24-32 Hours Post Operative Pain Level
Measured by the Numeric Pain Rating Scale (NRS) with a range of 0-10 where 0 represents No pain at all ( best outcome) and 10 represents Worst possible pain (worst outcome).
Time frame: 24-32 hours post operatively
Population: Overall Number of Participants Analyzed is not consistent with numbers provided Participant Flow module due to patients being discharged from hospital early or refusing reading; varying the number of results obtained in a specific time frame.~The analysis was done and revised by our Statistician
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intraperitoneal Normal Saline | 24-32 Hours Post Operative Pain Level | 3.2568 units on a scale | Standard Deviation 1.7858 |
| Intraperitoneal Ropivacaine | 24-32 Hours Post Operative Pain Level | 3.1974 units on a scale | Standard Deviation 1.9951 |
Primary
2-4 Hours Post Operative Pain Level
Measured by the Numeric Pain Rating Scale (NRS) with a range of 0-10 where 0 represents No pain at all ( best outcome) and 10 represents Worst possible pain (worst outcome).
Time frame: 2-4 hours post operatively
Population: Overall Number of Participants Analyzed is not consistent with numbers provided Participant Flow module due to patients refusing or being unable to provide the reading for outcome during the allocated time frame which could vary the number of results obtained in a specific time frame.~The analysis was done and revised by our Statistician
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intraperitoneal Normal Saline | 2-4 Hours Post Operative Pain Level | 3.2733 units on a scale | Standard Deviation 1.3186 |
| Intraperitoneal Ropivacaine | 2-4 Hours Post Operative Pain Level | 3.1978 units on a scale | Standard Deviation 1.1836 |
Primary
32-40 Hours Post Operative Pain Level
Measured by the Numeric Pain Rating Scale (NRS) with a range of 0-10 where 0 represents No pain at all ( best outcome) and 10 represents Worst possible pain (worst outcome).
Time frame: 32-40 hours post operatively
Population: Overall Number of Participants Analyzed is not consistent with numbers provided Participant Flow module due to patients being discharged from hospital early or refusing reading; varying the number of results obtained in a specific time frame.~The analysis was done and revised by our Statistician
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intraperitoneal Normal Saline | 32-40 Hours Post Operative Pain Level | 2.8143 units on a scale | Standard Deviation 1.7409 |
| Intraperitoneal Ropivacaine | 32-40 Hours Post Operative Pain Level | 2.9955 units on a scale | Standard Deviation 1.9079 |
Primary
40-48 Hours Post Operative Pain Level
Measured by the Numeric Pain Rating Scale (NRS) with a range of 0-10 where 0 represents No pain at all ( best outcome) and 10 represents Worst possible pain (worst outcome).
Time frame: 40-48 hours post operatively
Population: Overall Number of Participants Analyzed is not consistent with numbers provided Participant Flow module due to patients being discharged from hospital early or refusing reading; varying the number of results obtained in a specific time frame.~The analysis was done and revised by our Statistician
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intraperitoneal Normal Saline | 40-48 Hours Post Operative Pain Level | 2.7661 units on a scale | Standard Deviation 1.9842 |
| Intraperitoneal Ropivacaine | 40-48 Hours Post Operative Pain Level | 2.9394 units on a scale | Standard Deviation 1.3507 |
Primary
4-8 Hours Post Operative Pain Level
Measured by the Numeric Pain Rating Scale (NRS) with a range of 0-10 where 0 represents No pain at all ( best outcome) and 10 represents Worst possible pain (worst outcome).
Time frame: 4-8 hours post operatively
Population: Overall Number of Participants Analyzed is not consistent with numbers provided Participant Flow module due to patients refusing or being unable to provide the reading for outcome during the allocated time frame which could vary the number of results obtained in a specific time frame.~The analysis was done and revised by our Statistician
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intraperitoneal Normal Saline | 4-8 Hours Post Operative Pain Level | 3.6507 units on a scale | Standard Deviation 1.7729 |
| Intraperitoneal Ropivacaine | 4-8 Hours Post Operative Pain Level | 3.8387 units on a scale | Standard Deviation 1.6156 |
Primary
8-12 Hours Post Operative Pain Level
Measured by the Numeric Pain Rating Scale (NRS) with a range of 0-10 where 0 represents No pain at all ( best outcome) and 10 represents Worst possible pain (worst outcome).
Time frame: 8-12 hours post operatively
Population: Overall Number of Participants Analyzed is not consistent with numbers provided Participant Flow module due to patients refusing or being unable to provide the reading for outcome during the allocated time frame which could vary the number of results obtained in a specific time frame.~The analysis was done and revised by our Statistician
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intraperitoneal Normal Saline | 8-12 Hours Post Operative Pain Level | 3.7955 units on a scale | Standard Deviation 2.0667 |
| Intraperitoneal Ropivacaine | 8-12 Hours Post Operative Pain Level | 3.9056 units on a scale | Standard Deviation 1.6866 |
Secondary
0-1 h Postoperative Dilaudid Consumption
The amount in mg of Dilaudid administered to patient
Time frame: 0-1 hours post operatively
Population: Overall Number of Participants Analyzed is not consistent with numbers provided Participant Flow module due to patients refusing, Early Discharge or being unable to provide the reading for outcome during the allocated time frame which could vary the number of results obtained in a specific time frame.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intraperitoneal Normal Saline | 0-1 h Postoperative Dilaudid Consumption | 1008.9 mg | Standard Deviation 951.5 |
| Intraperitoneal Ropivacaine | 0-1 h Postoperative Dilaudid Consumption | 925 mg | Standard Deviation 641.8 |
Secondary
0-1 h Postoperative Fentanyl Consumption
The amount in mcg of Fentanyl administered to patient
Time frame: 0-1 hours post operatively
Population: Overall Number of Participants Analyzed is not consistent with numbers provided Participant Flow module due to patients refusing, Early Discharge or being unable to provide the reading for outcome during the allocated time frame which could vary the number of results obtained in a specific time frame.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intraperitoneal Normal Saline | 0-1 h Postoperative Fentanyl Consumption | 45.5556 mcg | Standard Deviation 43.722 |
| Intraperitoneal Ropivacaine | 0-1 h Postoperative Fentanyl Consumption | 42.9348 mcg | Standard Deviation 45.5409 |
Secondary
0-1 h Postoperative Ketorolac Consumption
The amount in mg of Ketorolac administered to patient
Time frame: 0-1 hours post operatively
Population: Overall Number of Participants Analyzed is not consistent with numbers provided Participant Flow module due to patients refusing, Early Discharge or being unable to provide the reading for outcome during the allocated time frame which could vary the number of results obtained in a specific time frame.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intraperitoneal Normal Saline | 0-1 h Postoperative Ketorolac Consumption | 5 mg | Standard Deviation 7.8335 |
| Intraperitoneal Ropivacaine | 0-1 h Postoperative Ketorolac Consumption | 6.413 mg | Standard Deviation 8.6707 |
Secondary
0-1 h Postoperative Tramadol Consumption
The amount in mg of Tramadol administered to patient
Time frame: 0-1 h Postoperative Tramadol consumption
Population: Overall Number of Participants Analyzed is not consistent with numbers provided Participant Flow module due to patients refusing, Early Discharge or being unable to provide the reading for outcome during the allocated time frame which could vary the number of results obtained in a specific time frame.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intraperitoneal Normal Saline | 0-1 h Postoperative Tramadol Consumption | 3.3333 mg | Standard Deviation 12.6131 |
| Intraperitoneal Ropivacaine | 0-1 h Postoperative Tramadol Consumption | 2.1739 mg | Standard Deviation 10.3092 |
Secondary
0-1 h Postoperative Tylenol Consumption
The amount in mg of Tylenol administered to the patient
Time frame: 0-1 hours post operatively
Population: Overall Number of Participants Analyzed is not consistent with numbers provided Participant Flow module due to patients refusing, Early Discharge or being unable to provide the reading for outcome during the allocated time frame which could vary the number of results obtained in a specific time frame.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intraperitoneal Normal Saline | 0-1 h Postoperative Tylenol Consumption | 72.2222 mg | Standard Deviation 206.6 |
| Intraperitoneal Ropivacaine | 0-1 h Postoperative Tylenol Consumption | 49.2391 mg | Standard Deviation 192.7 |
Secondary
12-24 h Postoperative Dilaudid Consumption
The amount in mg of Dilaudid administered to patient
Time frame: 12-24 hours post operatively
Population: Overall Number of Participants Analyzed is not consistent with numbers provided Participant Flow module due to patients refusing, Early Discharge or being unable to provide the reading for outcome during the allocated time frame which could vary the number of results obtained in a specific time frame.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intraperitoneal Normal Saline | 12-24 h Postoperative Dilaudid Consumption | 2066.7 mg | Standard Deviation 1923.5 |
| Intraperitoneal Ropivacaine | 12-24 h Postoperative Dilaudid Consumption | 2760.9 mg | Standard Deviation 3085.3 |
Secondary
12-24 h Postoperative Ketorolac Consumption
The amount in mg of Ketorolac administered to patient
Time frame: 12-24 hours post operatively
Population: Overall Number of Participants Analyzed is not consistent with numbers provided Participant Flow module due to patients refusing, Early Discharge or being unable to provide the reading for outcome during the allocated time frame which could vary the number of results obtained in a specific time frame.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intraperitoneal Normal Saline | 12-24 h Postoperative Ketorolac Consumption | 6.3333 mg | Standard Deviation 11.3016 |
| Intraperitoneal Ropivacaine | 12-24 h Postoperative Ketorolac Consumption | 5.5435 mg | Standard Deviation 10.1778 |
Secondary
12-24 h Postoperative Tramadol Consumption
The amount in mg of Tramadol administered to patient
Time frame: 12-24 hours post operatively
Population: Overall Number of Participants Analyzed is not consistent with numbers provided Participant Flow module due to patients refusing, Early Discharge or being unable to provide the reading for outcome during the allocated time frame which could vary the number of results obtained in a specific time frame.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intraperitoneal Normal Saline | 12-24 h Postoperative Tramadol Consumption | 141.1 mg | Standard Deviation 38.86 |
| Intraperitoneal Ropivacaine | 12-24 h Postoperative Tramadol Consumption | 138 mg | Standard Deviation 31.9458 |
Secondary
12-24 h Postoperative Tylenol Consumption
The amount in mg of Tylenol administered to patient
Time frame: 12-24 hours post operatively
Population: Overall Number of Participants Analyzed is not consistent with numbers provided Participant Flow module due to patients refusing, Early Discharge or being unable to provide the reading for outcome during the allocated time frame which could vary the number of results obtained in a specific time frame.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intraperitoneal Normal Saline | 12-24 h Postoperative Tylenol Consumption | 1921.1 mg | Standard Deviation 414.7 |
| Intraperitoneal Ropivacaine | 12-24 h Postoperative Tylenol Consumption | 1837 mg | Standard Deviation 460.7 |
Secondary
12h Peak Expiratory Flow (PEF) Score
Measured using the Mini Wright Peak flow meter with a range of 60-800 L/Min where 60 L/Min represents the worst possible score and 800 L/Min represents the best possible score. Value recorded is based on an average of 3 readings at every time point.
Time frame: 12 hours post operatively
Population: Overall Number of Participants Analyzed is not consistent with numbers provided Participant Flow module due to patients refusing or being unable to provide the reading for outcome during the allocated time frame which could vary the number of results obtained in a specific time frame.~The analysis was done and revised by our Statistician
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intraperitoneal Normal Saline | 12h Peak Expiratory Flow (PEF) Score | 240 L/min | Standard Deviation 88.7052 |
| Intraperitoneal Ropivacaine | 12h Peak Expiratory Flow (PEF) Score | 241.6 L/min | Standard Deviation 73.7843 |
Secondary
1-2 h Postoperative Dilaudid Consumption
The amount in mg of Dilaudid administered to patient
Time frame: 1-2 hours post operatively
Population: Overall Number of Participants Analyzed is not consistent with numbers provided Participant Flow module due to patients refusing, Early Discharge or being unable to provide the reading for outcome during the allocated time frame which could vary the number of results obtained in a specific time frame.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intraperitoneal Normal Saline | 1-2 h Postoperative Dilaudid Consumption | 291.1 mg | Standard Deviation 488.9 |
| Intraperitoneal Ropivacaine | 1-2 h Postoperative Dilaudid Consumption | 489.1 mg | Standard Deviation 582.8 |
Secondary
1-2 h Postoperative Fentanyl Consumption
The amount in mcg of Fentanyl administered to patient
Time frame: 1-2 hours post operatively
Population: Overall Number of Participants Analyzed is not consistent with numbers provided Participant Flow module due to patients refusing, Early Discharge or being unable to provide the reading for outcome during the allocated time frame which could vary the number of results obtained in a specific time frame.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intraperitoneal Normal Saline | 1-2 h Postoperative Fentanyl Consumption | 10 mcg | Standard Deviation 17.9962 |
| Intraperitoneal Ropivacaine | 1-2 h Postoperative Fentanyl Consumption | 7.6087 mcg | Standard Deviation 16.5576 |
Secondary
1-2 h Postoperative Ketorolac Consumption
The amount in mg of Ketorolac administered to patient
Time frame: 1-2 hours post operatively
Population: Overall Number of Participants Analyzed is not consistent with numbers provided Participant Flow module due to patients refusing, Early Discharge or being unable to provide the reading for outcome during the allocated time frame which could vary the number of results obtained in a specific time frame.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intraperitoneal Normal Saline | 1-2 h Postoperative Ketorolac Consumption | 2.3333 mg | Standard Deviation 6.3604 |
| Intraperitoneal Ropivacaine | 1-2 h Postoperative Ketorolac Consumption | 2.3913 mg | Standard Deviation 5.3478 |
Secondary
1-2 h Postoperative Tramadol Consumption
The amount in mg of Tramadol administered to patient
Time frame: 1-2 hours post operatively
Population: Overall Number of Participants Analyzed is not consistent with numbers provided Participant Flow module due to patients refusing, Early Discharge or being unable to provide the reading for outcome during the allocated time frame which could vary the number of results obtained in a specific time frame.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intraperitoneal Normal Saline | 1-2 h Postoperative Tramadol Consumption | 9.4444 mg | Standard Deviation 19.43 |
| Intraperitoneal Ropivacaine | 1-2 h Postoperative Tramadol Consumption | 8.6957 mg | Standard Deviation 19.1612 |
Secondary
1-2 h Postoperative Tylenol Consumption
The amount in mg of Tylenol administered to patient
Time frame: 1-2 hours post operatively
Population: Overall Number of Participants Analyzed is not consistent with numbers provided Participant Flow module due to patients refusing, Early Discharge or being unable to provide the reading for outcome during the allocated time frame which could vary the number of results obtained in a specific time frame.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intraperitoneal Normal Saline | 1-2 h Postoperative Tylenol Consumption | 144.2 mg | Standard Deviation 272.9 |
| Intraperitoneal Ropivacaine | 1-2 h Postoperative Tylenol Consumption | 141.3 mg | Standard Deviation 271.1 |
Secondary
16h Peak Expiratory Flow (PEF) Score
Measured using the Mini Wright Peak flow meter with a range of 60-800 L/Min where 60 L/Min represents the worst possible score and 800 L/Min represents the best possible score. Value recorded is based on an average of 3 readings at every time point.
Time frame: 16 hours post operatively
Population: Overall Number of Participants Analyzed is not consistent with numbers provided Participant Flow module due to patients refusing or being unable to provide the reading for outcome during the allocated time frame which could vary the number of results obtained in a specific time frame.~The analysis was done and revised by our Statistician
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intraperitoneal Normal Saline | 16h Peak Expiratory Flow (PEF) Score | 233.4 L/min | Standard Deviation 86.6212 |
| Intraperitoneal Ropivacaine | 16h Peak Expiratory Flow (PEF) Score | 242.2 L/min | Standard Deviation 76.4464 |
Secondary
1h Peak Expiratory Flow (PEF) Score
Measured using the Mini Wright Peak flow meter with a range of 60-800 L/Min where 60 L/Min represents the worst possible score and 800 L/Min represents the best possible score. Value recorded is based on an average of 3 readings at every time point.
Time frame: 1 hours post operatively
Population: Overall Number of Participants Analyzed is not consistent with numbers provided Participant Flow module due to patients refusing or being unable to provide the reading for outcome during the allocated time frame which could vary the number of results obtained in a specific time frame.~The analysis was done and revised by our Statistician
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intraperitoneal Normal Saline | 1h Peak Expiratory Flow (PEF) Score | 202.9 L/min | Standard Deviation 99.9948 |
| Intraperitoneal Ropivacaine | 1h Peak Expiratory Flow (PEF) Score | 200.3 L/min | Standard Deviation 88.4809 |
Secondary
20h Peak Expiratory Flow (PEF) Score
Measured using the Mini Wright Peak flow meter with a range of 60-800 L/Min where 60 L/Min represents the worst possible score and 800 L/Min represents the best possible score. Value recorded is based on an average of 3 readings at every time point.
Time frame: 20 hours post operatively
Population: Overall Number of Participants Analyzed is not consistent with numbers provided Participant Flow module due to patients refusing or being unable to provide the reading for outcome during the allocated time frame which could vary the number of results obtained in a specific time frame.~The analysis was done and revised by our Statistician
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intraperitoneal Normal Saline | 20h Peak Expiratory Flow (PEF) Score | 246 L/min | Standard Deviation 97.9415 |
| Intraperitoneal Ropivacaine | 20h Peak Expiratory Flow (PEF) Score | 245.1 L/min | Standard Deviation 66.3817 |
Secondary
24-48 h Postoperative Dilaudid Consumption
The amount in mg of Dilaudid administered to patient
Time frame: 24-48 hours post operatively
Population: Overall Number of Participants Analyzed is not consistent with numbers provided Participant Flow module due to patients refusing, Early Discharge or being unable to provide the reading for outcome during the allocated time frame which could vary the number of results obtained in a specific time frame.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intraperitoneal Normal Saline | 24-48 h Postoperative Dilaudid Consumption | 2933.3 mg | Standard Deviation 3563.7 |
| Intraperitoneal Ropivacaine | 24-48 h Postoperative Dilaudid Consumption | 3000 mg | Standard Deviation 3489.7 |
Secondary
24-48 h Postoperative Ketorolac Consumption
The amount in mg of Ketorolac administered to patient
Time frame: 24-48 hours post operatively
Population: Overall Number of Participants Analyzed is not consistent with numbers provided Participant Flow module due to patients refusing, Early Discharge or being unable to provide the reading for outcome during the allocated time frame which could vary the number of results obtained in a specific time frame.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intraperitoneal Normal Saline | 24-48 h Postoperative Ketorolac Consumption | 2.3333 mg | Standard Deviation 7.8044 |
| Intraperitoneal Ropivacaine | 24-48 h Postoperative Ketorolac Consumption | 3.2609 mg | Standard Deviation 8.8955 |
Secondary
24-48 h Postoperative Tramadol Consumption
The amount in mg of Tramadol administered to patient
Time frame: 24-48 hours post operatively
Population: Overall Number of Participants Analyzed is not consistent with numbers provided Participant Flow module due to patients refusing, Early Discharge or being unable to provide the reading for outcome during the allocated time frame which could vary the number of results obtained in a specific time frame.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intraperitoneal Normal Saline | 24-48 h Postoperative Tramadol Consumption | 216.7 mg | Standard Deviation 97.1175 |
| Intraperitoneal Ropivacaine | 24-48 h Postoperative Tramadol Consumption | 215.2 mg | Standard Deviation 101.6 |
Secondary
24-48 h Postoperative Tylenol Consumption
The amount in mg of Tylenol administered to patient
Time frame: 24-48 hours post operatively
Population: Overall Number of Participants Analyzed is not consistent with numbers provided Participant Flow module due to patients refusing, Early Discharge or being unable to provide the reading for outcome during the allocated time frame which could vary the number of results obtained in a specific time frame.
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| Intraperitoneal Normal Saline | 24-48 h Postoperative Tylenol Consumption | 3033.3 mg | Standard Deviation 1239.5 |
| Intraperitoneal Ropivacaine | 24-48 h Postoperative Tylenol Consumption | 2826.1 mg | Standard Deviation 1330.1 |
Secondary
24h Peak Expiratory Flow (PEF) Score
Measured using the Mini Wright Peak flow meter with a range of 60-800 L/Min where 60 L/Min represents the worst possible score and 800 L/Min represents the best possible score. Value recorded is based on an average of 3 readings at every time point.
Time frame: 24 hours post operatively
Population: Overall Number of Participants Analyzed is not consistent with numbers provided Participant Flow module due to patients refusing or being unable to provide the reading for outcome during the allocated time frame which could vary the number of results obtained in a specific time frame.~The analysis was done and revised by our Statistician
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intraperitoneal Normal Saline | 24h Peak Expiratory Flow (PEF) Score | 255.2 L/min | Standard Deviation 92.1195 |
| Intraperitoneal Ropivacaine | 24h Peak Expiratory Flow (PEF) Score | 253.8 L/min | Standard Deviation 73.1017 |
Secondary
2-4 h Postoperative Dilaudid Consumption
The amount in mg of Dilaudid administered to patient
Time frame: 2-4 hours post operatively
Population: Overall Number of Participants Analyzed is not consistent with numbers provided Participant Flow module due to patients refusing, Early Discharge or being unable to provide the reading for outcome during the allocated time frame which could vary the number of results obtained in a specific time frame.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intraperitoneal Normal Saline | 2-4 h Postoperative Dilaudid Consumption | 415.6 mg | Standard Deviation 604.5 |
| Intraperitoneal Ropivacaine | 2-4 h Postoperative Dilaudid Consumption | 484.8 mg | Standard Deviation 707.4 |
Secondary
2-4 h Postoperative Fentanyl Consumption
The amount in mcg of Fentanyl administered to patient
Time frame: 2-4 hours post operatively
Population: Overall Number of Participants Analyzed is not consistent with numbers provided Participant Flow module due to patients refusing, Early Discharge or being unable to provide the reading for outcome during the allocated time frame which could vary the number of results obtained in a specific time frame.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intraperitoneal Normal Saline | 2-4 h Postoperative Fentanyl Consumption | 4.4444 mcg | Standard Deviation 13.3663 |
| Intraperitoneal Ropivacaine | 2-4 h Postoperative Fentanyl Consumption | 33.1522 mcg | Standard Deviation 191.6 |
Secondary
2-4 h Postoperative Ketorolac Consumption
The amount in mg of Ketorolac administered to patient
Time frame: 2-4 hours post operatively
Population: Overall Number of Participants Analyzed is not consistent with numbers provided Participant Flow module due to patients refusing, Early Discharge or being unable to provide the reading for outcome during the allocated time frame which could vary the number of results obtained in a specific time frame.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intraperitoneal Normal Saline | 2-4 h Postoperative Ketorolac Consumption | 3.2222 mg | Standard Deviation 6.9213 |
| Intraperitoneal Ropivacaine | 2-4 h Postoperative Ketorolac Consumption | 1.0087 mg | Standard Deviation 3.7421 |
Secondary
2-4 h Postoperative Tramadol Consumption
The amount in mg of Tramadol administered to patient
Time frame: 2-4 hours post operatively
Population: Overall Number of Participants Analyzed is not consistent with numbers provided Participant Flow module due to patients refusing, Early Discharge or being unable to provide the reading for outcome during the allocated time frame which could vary the number of results obtained in a specific time frame.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intraperitoneal Normal Saline | 2-4 h Postoperative Tramadol Consumption | 12.2222 mg | Standard Deviation 21.7307 |
| Intraperitoneal Ropivacaine | 2-4 h Postoperative Tramadol Consumption | 15.2174 mg | Standard Deviation 23.2608 |
Secondary
2-4 h Postoperative Tylenol Consumption
The amount in mg of Tylenol administered to patient
Time frame: 2-4 hours post operatively
Population: Overall Number of Participants Analyzed is not consistent with numbers provided Participant Flow module due to patients refusing, Early Discharge or being unable to provide the reading for outcome during the allocated time frame which could vary the number of results obtained in a specific time frame.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intraperitoneal Normal Saline | 2-4 h Postoperative Tylenol Consumption | 216.4 mg | Standard Deviation 309.6 |
| Intraperitoneal Ropivacaine | 2-4 h Postoperative Tylenol Consumption | 240.2 mg | Standard Deviation 317.2 |
Secondary
2h Peak Expiratory Flow (PEF) Score
Measured using the Mini Wright Peak flow meter with a range of 60-800 L/Min where 60 L/Min represents the worst possible score and 800 L/Min represents the best possible score. Value recorded is based on an average of 3 readings at every time point.
Time frame: 2 hours post operatively
Population: Overall Number of Participants Analyzed is not consistent with numbers provided Participant Flow module due to patients refusing or being unable to provide the reading for outcome during the allocated time frame which could vary the number of results obtained in a specific time frame.~The analysis was done and revised by our Statistician
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intraperitoneal Normal Saline | 2h Peak Expiratory Flow (PEF) Score | 243 L/min | Standard Deviation 104.1 |
| Intraperitoneal Ropivacaine | 2h Peak Expiratory Flow (PEF) Score | 239.8 L/min | Standard Deviation 84.9128 |
Secondary
32h Peak Expiratory Flow (PEF) Score
Measured using the Mini Wright Peak flow meter with a range of 60-800 L/Min where 60 L/Min represents the worst possible score and 800 L/Min represents the best possible score. Value recorded is based on an average of 3 readings at every time point.
Time frame: 32 hours post operatively
Population: Overall Number of Participants Analyzed is not consistent with numbers provided Participant Flow module due to patients refusing or being unable to provide the reading for outcome during the allocated time frame which could vary the number of results obtained in a specific time frame.~The analysis was done and revised by our Statistician
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intraperitoneal Normal Saline | 32h Peak Expiratory Flow (PEF) Score | 256.62 L/min | Standard Deviation 95.183 |
| Intraperitoneal Ropivacaine | 32h Peak Expiratory Flow (PEF) Score | 265.5 L/min | Standard Deviation 84.941 |
Secondary
40h Peak Expiratory Flow (PEF) Score
Measured using the Mini Wright Peak flow meter with a range of 60-800 L/Min where 60 L/Min represents the worst possible score and 800 L/Min represents the best possible score. Value recorded is based on an average of 3 readings at every time point.
Time frame: 40 hours post operatively
Population: Overall Number of Participants Analyzed is not consistent with numbers provided Participant Flow module due to patients refusing or being unable to provide the reading for outcome during the allocated time frame which could vary the number of results obtained in a specific time frame.~The analysis was done and revised by our Statistician
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intraperitoneal Normal Saline | 40h Peak Expiratory Flow (PEF) Score | 255.3 L/min | Standard Deviation 96.6315 |
| Intraperitoneal Ropivacaine | 40h Peak Expiratory Flow (PEF) Score | 265.8 L/min | Standard Deviation 81.654 |
Secondary
4-12 h Postoperative Dilaudid Consumption
The amount in mg of Dilaudid administered to patient
Time frame: 4-12 hours post operatively
Population: Overall Number of Participants Analyzed is not consistent with numbers provided Participant Flow module due to patients refusing, Early Discharge or being unable to provide the reading for outcome during the allocated time frame which could vary the number of results obtained in a specific time frame.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intraperitoneal Normal Saline | 4-12 h Postoperative Dilaudid Consumption | 2000 mg | Standard Deviation 1714.1 |
| Intraperitoneal Ropivacaine | 4-12 h Postoperative Dilaudid Consumption | 1830.4 mg | Standard Deviation 2018.1 |
Secondary
4-12 h Postoperative Ketorolac Consumption
The amount in mg of Ketorolac administered to patient
Time frame: 4-12 hours post operatively
Population: Overall Number of Participants Analyzed is not consistent with numbers provided Participant Flow module due to patients refusing, Early Discharge or being unable to provide the reading for outcome during the allocated time frame which could vary the number of results obtained in a specific time frame.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intraperitoneal Normal Saline | 4-12 h Postoperative Ketorolac Consumption | 6.8889 mg | Standard Deviation 11.2961 |
| Intraperitoneal Ropivacaine | 4-12 h Postoperative Ketorolac Consumption | 5.2174 mg | Standard Deviation 9.065 |
Secondary
4-12 h Postoperative Tramadol Consumption
The amount in mg of Tramadol administered to patient
Time frame: 4-12 hours post operatively
Population: Overall Number of Participants Analyzed is not consistent with numbers provided Participant Flow module due to patients refusing, Early Discharge or being unable to provide the reading for outcome during the allocated time frame which could vary the number of results obtained in a specific time frame.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intraperitoneal Normal Saline | 4-12 h Postoperative Tramadol Consumption | 81.1111 mg | Standard Deviation 38.86 |
| Intraperitoneal Ropivacaine | 4-12 h Postoperative Tramadol Consumption | 85.8696 mg | Standard Deviation 31.0252 |
Secondary
4-12 h Postoperative Tylenol Consumption
The amount in mg of Tylenol administered to patient
Time frame: 4-12 hours post operatively
Population: Overall Number of Participants Analyzed is not consistent with numbers provided Participant Flow module due to patients refusing, Early Discharge or being unable to provide the reading for outcome during the allocated time frame which could vary the number of results obtained in a specific time frame.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intraperitoneal Normal Saline | 4-12 h Postoperative Tylenol Consumption | 1140.9 mg | Standard Deviation 441.5 |
| Intraperitoneal Ropivacaine | 4-12 h Postoperative Tylenol Consumption | 1187 mg | Standard Deviation 394.9 |
Secondary
48h Peak Expiratory Flow (PEF) Score
Measured using the Mini Wright Peak flow meter with a range of 60-800 L/Min where 60 L/Min represents the worst possible score and 800 L/Min represents the best possible score. Value recorded is based on an average of 3 readings at every time point.
Time frame: 48 hours post operatively
Population: Overall Number of Participants Analyzed is not consistent with numbers provided Participant Flow module due to patients refusing, early Discharge or being unable to provide the reading for outcome during the allocated time frame which could vary the number of results obtained in a specific time frame.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intraperitoneal Normal Saline | 48h Peak Expiratory Flow (PEF) Score | 285.3 L/min | Standard Deviation 97.1162 |
| Intraperitoneal Ropivacaine | 48h Peak Expiratory Flow (PEF) Score | 285.3 L/min | Standard Deviation 84.6803 |
Secondary
4h Peak Expiratory Flow (PEF) Score
Measured using the Mini Wright Peak flow meter with a range of 60-800 L/Min where 60 L/Min represents the worst possible score and 800 L/Min represents the best possible score. Value recorded is based on an average of 3 readings at every time point.
Time frame: 4 hours post operatively
Population: Overall Number of Participants Analyzed is not consistent with numbers provided Participant Flow module due to patients refusing or being unable to provide the reading for outcome during the allocated time frame which could vary the number of results obtained in a specific time frame.~The analysis was done and revised by our Statistician
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intraperitoneal Normal Saline | 4h Peak Expiratory Flow (PEF) Score | 251.9 L/min | Standard Deviation 93.5798 |
| Intraperitoneal Ropivacaine | 4h Peak Expiratory Flow (PEF) Score | 256.1 L/min | Standard Deviation 77.5092 |
Secondary
6 Minute Walking Distance Post Operative Day 1 (POD1)
6-Minute walk distance (6MWD)-Defined as the distance in (m) an individual is able to walk a long a flat 30 m walkway over six--minute period, with breaks as required. walk testing has been validated in the obese population, clinically significant differences occur when distances of at least 80m occur. 0 m would be the worst possible value for this outcome and the higher the number achieved in the six-minute duration the better (Better outcome)
Time frame: Post operative day 1
Population: Overall Number of Participants Analyzed is not consistent with numbers provided Participant Flow module due to patients refusing or being unable to provide the reading for outcome during the allocated time frame which could vary the number of results obtained in a specific time frame.~The analysis was done and revised by our Statistician
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intraperitoneal Normal Saline | 6 Minute Walking Distance Post Operative Day 1 (POD1) | 205.8 Meters | Standard Deviation 94.3378 |
| Intraperitoneal Ropivacaine | 6 Minute Walking Distance Post Operative Day 1 (POD1) | 182.4 Meters | Standard Deviation 97.1065 |
Secondary
6 Minute Walking Distance Post Operative Day 2 (POD2)
6-Minute walk distance (6MWD)-Defined as the distance in (m) an individual is able to walk a long a flat 30 m walkway over six--minute period, with breaks as required. walk testing has been validated in the obese population, clinically significant differences occur when distances of at least 80m occur. 0 m would be the worst possible value for this outcome and the higher the number achieved in the six-minute duration the better (Better outcome)
Time frame: Post operative day 2
Population: Overall Number of Participants Analyzed is not consistent with numbers provided Participant Flow module due to patients refusing, Early Discharge or being unable to provide the reading for outcome during the allocated time frame which could vary the number of results obtained in a specific time frame.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intraperitoneal Normal Saline | 6 Minute Walking Distance Post Operative Day 2 (POD2) | 260 Meters | Standard Deviation 87.8853 |
| Intraperitoneal Ropivacaine | 6 Minute Walking Distance Post Operative Day 2 (POD2) | 217.2 Meters | Standard Deviation 101.7 |
Secondary
6 Minute Walking Distance Post Operative Day 7-10 (POD 7-10)
6-Minute walk distance (6MWD)-Defined as the distance in (m) an individual is able to walk a long a flat 30 m walkway over six--minute period, with breaks as required. walk testing has been validated in the obese population, clinically significant differences occur when distances of at least 80m occur. 0 m would be the worst possible value for this outcome and the higher the number achieved in the six-minute duration the better (Better outcome)
Time frame: Post operative day 7-10 (Follow-up Clinic)
Population: Overall Number of Participants Analyzed is not consistent with numbers provided Participant Flow module due to patients refusing, Missing Appointment or being unable to provide the reading for outcome during the allocated time frame which could vary the number of results obtained in a specific time frame.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intraperitoneal Normal Saline | 6 Minute Walking Distance Post Operative Day 7-10 (POD 7-10) | 373.3 meters | Standard Deviation 68.1203 |
| Intraperitoneal Ropivacaine | 6 Minute Walking Distance Post Operative Day 7-10 (POD 7-10) | 352.4 meters | Standard Deviation 90.2276 |
Secondary
8h Peak Expiratory Flow (PEF) Score
Measured using the Mini Wright Peak flow meter with a range of 60-800 L/Min where 60 L/Min represents the worst possible score and 800 L/Min represents the best possible score. Value recorded is based on an average of 3 readings at every time point.
Time frame: 8 hours post operatively
Population: Overall Number of Participants Analyzed is not consistent with numbers provided Participant Flow module due to patients refusing or being unable to provide the reading for outcome during the allocated time frame which could vary the number of results obtained in a specific time frame.~The analysis was done and revised by our Statistician
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intraperitoneal Normal Saline | 8h Peak Expiratory Flow (PEF) Score | 250.9 L/min | Standard Deviation 81.9403 |
| Intraperitoneal Ropivacaine | 8h Peak Expiratory Flow (PEF) Score | 255.3 L/min | Standard Deviation 86.4081 |
Secondary
Postoperative Day 1 Quality of Recovery Questionnaire (QR-40)
40-item questionnaire provides a global score(Minimum-score 40, Maximum-Score 200, Higher score represent better Quality of recovery of participant in both global and subscores) subscores(summed to total the global score) across five dimensions explained below, in all categories minimum score is 1, maximum score of 5 for each question.unit is scores on a scale for all questions. Emotional\_State:9 questions subscore can range between 9-45 Physical\_Comfort:12 questions, subscore range between 12-60 Psychological Support:7 questions, subscore range between 7-35 Physical\_Independence:5 questions, subscore range between 5-25 Pain:7 questions, subscore range between 5-25 Questionnaire has two parts A and B, In part A, a score of 1 represents the answer of None of the time (Poor)and 5 represents the answerAll of the time (Excellent)Part B, score of 1 represents the answerAll of the time (Excellent) and 5 representsNone of the time (Poor)
Time frame: Post operative day 1
Population: Overall Number of Participants Analyzed is not consistent with numbers provided Participant Flow module due to patients refusing, Early Discharge or being unable to provide the reading for outcome during the allocated time frame which could vary the number of results obtained in a specific time frame.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intraperitoneal Normal Saline | Postoperative Day 1 Quality of Recovery Questionnaire (QR-40) | 163 Scores on a scale | Standard Deviation 16.4944 |
| Intraperitoneal Ropivacaine | Postoperative Day 1 Quality of Recovery Questionnaire (QR-40) | 163.6 Scores on a scale | Standard Deviation 14.6931 |
Secondary
Postoperative Day 7-10 Quality of Recovery Questionnaire (QR-40)
40-item questionnaire provides a global score(Minimum-score 40,Maximum-Score 200, Higher score represent better Quality of recovery of participant in both global and subscores) subscores(summed to total the global score) across five dimensions explained below, in all categories minimum score is 1,maximum score of 5 for each question.unit is scores on a scale for all questions. Emotional\_State:9 questions subscore can range between 9-45 Physical\_Comfort:12 questions, subscore range between 12-60 Psychological Support:7 questions, subscore range between 7-35 Physical\_Independence:5 questions, subscore range between 5-25 Pain:7 questions,subscore range between 5-25 Questionnaire has two parts A and B, In part A, a score of 1 represents the answer of None of the time (Poor)and 5 represents the answerAll of the time (Excellent)Part B, score of 1 represents the answerAll of the time (Excellent) and 5 representsNone of the time (Poor)
Time frame: Post operative day 7-10
Population: Overall Number of Participants Analyzed is not consistent with numbers provided Participant Flow module due to patients refusing, Early Discharge or being unable to provide the reading for outcome during the allocated time frame which could vary the number of results obtained in a specific time frame.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intraperitoneal Normal Saline | Postoperative Day 7-10 Quality of Recovery Questionnaire (QR-40) | 183.5 Scores on a scale | Standard Deviation 14.1829 |
| Intraperitoneal Ropivacaine | Postoperative Day 7-10 Quality of Recovery Questionnaire (QR-40) | 182.7 Scores on a scale | Standard Deviation 14.0707 |