Kidney Cancer, Prostate Cancer
Conditions
Keywords
prostatectomy, partial nephrectomy, robotic surgery, intravenous lidocaine, lidocaine hydrochloride
Brief summary
Controlling pain is fundamental during and after surgical procedures. This study examines pain associated with robotic assisted surgery on prostate cancer or a kidney mass. In recent years, the risk of opioids in the postoperative period has gained interest due to the growing epidemic of addiction, dependence, and overdose. In this study, the investigators expect a continuous infusion of intravenous lidocaine during the perioperative period to result in less pain and less opioid use.
Detailed description
In recent years, the risk of opioids in the post-operative period has gained interest due to the growing epidemic of addiction, dependence, and overdose. The rate of drug overdose secondary to opioids has continued to increase at an alarming rate. This has been a primary point of concern in all fields of medicine and Urology has not been an exception. This is also a nationwide government and public health concern. This has generated an increased focus on the use of non-opioid analgesics after surgery such as intravenous lidocaine. Opioids remain the primary source of relief for postoperative pain and have the potential to lead to significant morbidity. Opioids may delay recovery following surgery and have many well-known adverse effects including, but not limited to, nausea, vomiting and prolonged post-operative ileus. Furthermore, in one study, they inadequately provided pain control in 50-60% of postoperative participants. This is a frequent report of participants because of the less than optimal utilization of the medications in fear of their dose dependent adverse effects and various contraindications. On the other hand, surplus medication following surgery is another prominent component of the opioid problem in Urologic practices. Bates et al. found that of the 586 participants that underwent a urological procedure that they reviewed, 67% of them had collected surplus medication. It is both necessary and beneficial for surgeons and participants to utilize dose-sparing strategies following surgery to decrease overall opioid usage and outpatient requirement. One mechanism that has already been employed for overall improvement in prostatectomies and partial nephrectomies is the use of the robotic assisted approach. Robot assisted partial nephrectomies (RALPN) and robotic assisted laparoscopic prostatectomies (RALP) are becoming a mainstay in urologic surgery and increasing annually. This coincides with a continuous downward trend of laparoscopic and open urologic procedures. RALPN has been shown in a meta-analysis to be more favorable than laparoscopic partial nephrectomies and will continue to be the surgical procedure of choice in the near future. RALP is also now the dominant surgical approach while open and laparoscopic prostatectomies becoming less frequent. Robotic assisted surgery is associated with improved functional outcomes, pain scores, shorter hospital stays, and increases in participants satisfaction in many studies. While there has been a pronounced increase in robotic surgery over the past 10 years that has demonstrated benefits for participants, there has been limited studies regarding the pain management for these participants. Robotic assisted surgery itself decreases pain levels compared to other approaches, but participants continue to experience mild to moderate pain levels in the postoperative period, which are classically managed with NSAIDs and opioids. Recently, Enhanced Recovery after Surgery protocols (ERAS) have been implemented in an attempt to decrease pain and opioid use as one outcome. ERAS utilizes multimodal analgesia and has shown improvement of participant satisfaction and perioperative opioid use. Systemic lidocaine is becoming more popular and regularly applied through this protocol and, other practices, in due to its analgesic, anti-hyperalgesia and anti-inflammatory properties that it contains. Systemic lidocaine mechanism of action is not fully understood, but it appears to be multifaceted. Systemic lidocaine inhibits voltage-gated sodium channels in both the peripheral and central nervous system. This is believed to cause an additive effect when combined with inhaled anesthetics which also work on the voltage-gated sodium channels in the central nervous system. Despite this summative effect, this is likely not the primary mechanism of action. Instead, it is believed to predominantly act on anti-inflammatory signaling and through inhibiting neuronal effects. Additionally, it reduces nociception and cardiovascular response to surgical stress and pain. This is a prospective, randomized, double-blinded, placebo-controlled clinical trial on lidocaine infusion for pain control and opioid consumption in participants undergoing either robotic-assisted laparoscopic prostatectomy or robotic-assisted laparoscopic partial nephrectomy at University of Missouri Hospital. Participants will be randomized in a 1:1 fashion and stratified by the type of surgery to receive a perioperative intravenous 0.8% lidocaine infusion at 1 mg/kg/h if \< age 65 and 0.5 mg/kg/h if ≥ age 65 or an equal volume and rate of normal saline as a placebo. The infusion will be started 15 minutes after endotracheal intubation and continue for 24 hours. The study that the investigators propose targets an area of urology that is underrepresented in the current literature despite its increasing importance. To the best of the investigator's knowledge, this has not been directly studied before, although it has been utilized numerous times in the ERAS protocol at the University of Missouri Hospital throughout the Division of Urology and Anesthesiology & Perioperative Medicine in participants undergoing robotic surgery. The benefits of intravenous lidocaine have been demonstrated in other areas and these results warrant a prospective, randomized, double-blinded, placebo controlled study to assess the lidocaine infusion effects for robot assisted laparoscopic prostatectomies and partial nephrectomies. As the number of robotic assisted surgeries and emphasis on opioid reduction continues, the evaluation of systemic lidocaine will be important in improving outcomes in urology.
Interventions
DRUGLidocaine Hydrochloride 0.8% in Dextrose 5% Solution
Lidocaine Hydrochloride and 5% Dextrose Injection, USP is a sterile, nonpyrogenic solution prepared from lidocaine hydrochloride and dextrose in water for injection.
DRUG0.9% Sodium Chloride Injection
Sodium Chloride Injection USP is sterile, nonpyrogenic, isotonic and contains no bacteriostatic or antimicrobial agents.
Sponsors
University of Missouri-Columbia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
The surgeon, anesthesiologist, operating room staff, participant, personnel in the postanesthesia care unit (PACU) as well as the investigators collecting the postoperative data will be blinded to the group allocation. Study medication is prepared and masked by an unblinded investigation drug pharmacist who is not involved in clinical care.
Intervention model description
Participants will receive either intraoperative 0.8% lidocaine or normal saline at 1 mg/kg/h when younger than 65 years and 0.5 mg/kg/h when greater than or equal to the age of 65 to be delivered by continuous infusion for 24 hours.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Undergoing robotic assisted prostatectomy or robotic assisted partial nephrectomy at University of Missouri Hospital for prostate cancer or kidney mass * Age ≥ 18 years * ASA I-III
Exclusion criteria
* Inability to obtain written informed consent * Allergy to lidocaine or other amide local anesthetics * Atrioventricular conduction blocks * CV instability and concomitant use of alpha agonists or beta blockers * Recent myocardial infarction (≤ 6 months ago) * Cardiac arrhythmia disorders * Stokes-Adams syndrome * Wolff-Parkinson-White syndrome * Seizure disorders * Liver failure or hepatic dysfunction * Significant renal disease with a serum creatinine ≥ 2 mg/dl * A family history of malignant hyperthermia * Current use of opioids or documented history of opioid abuse * Typically, have less than 3 bowel movement per week * Combined surgical cases that include robotic prostatectomy or robotic partial nephrectomy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Difference in Post-operative Pain Scores Measured by Visual Analog Scale | Through study completion, assessed at 1h, 2h, 4h, 6h, 12h and 24h post operatively, then every 24 hours until discharge, and at the post operative visit which occurred within 21-days post-operatively. | 10-cm Visual Analog Scale (VAS), score of 0 no pain to a score of 10 worst pain ever |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Length of Hospital Stay | At participant discharge, assessed up to 14 days (+/-) 7 days | Difference in length of hospital stay determined by surgeon excluding social factors that may delay discharge |
| Duration of Post-operative Ileus | Through study completion, assessed at 1h, 2h, 4h, 6h, 12h and 24h post operatively, then every 24 hours until discharge, and at the post operative visit which occurred within 21-days post-operatively. | Difference in post-operative Ileus duration |
| Post-operative PACU Time | During hospitalization, approximately 2 hours post-surgery | Difference in time in the Post Anesthesia Care Unit (PACU) after surgery |
| Opioid Consumption | Through study completion, assessed for first 24-hours post operatively, then every 24 hours until discharge, and at the post operative visit which occurred within 21-days post-operatively. | Difference in opioid consumption in first 24 hours, discharge and 21 days post-operatively (morphine equivalents) |
| Time to Out of Bed | During hospitalization regular intervals for the first 24 hours, then every 24 hours until discharge. | Difference in time to out of bed to chair after surgery |
| First Ambulation in the Hallway | During hospitalization at 1h, 2h, 4h, 6h, 12h, and 24h post operatively, then every 24 hours until discharge. | Difference in time to first ambulation in the hallway after surgery |
| Return of Flatus | During hospitalization at 1h, 2h, 4h, 6h, 12h, and 24h post operatively, then every 24 hours thereafter until discharge. | Difference in return of flatus after surgery |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Treatment Group Lidocaine Hydrochloride infusion
The treatment group received a perioperative and intraoperative infusion of 0.8% lidocaine at 1mg/kg/h. | 11 |
| Control Group Normal saline
The control group received normal saline. | 10 |
| Total | 21 |
Baseline characteristics
| Characteristic | Treatment Group | Control Group | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 7 Participants | 5 Participants | 12 Participants |
| Age, Categorical Between 18 and 65 years | 4 Participants | 5 Participants | 9 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 11 Participants | 10 Participants | 21 Participants |
| Sex: Female, Male Female | 2 Participants | 1 Participants | 3 Participants |
| Sex: Female, Male Male | 9 Participants | 9 Participants | 18 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 11 | 0 / 10 |
| other Total, other adverse events | 0 / 11 | 0 / 10 |
| serious Total, serious adverse events | 0 / 11 | 0 / 10 |
Outcome results
Primary
Difference in Post-operative Pain Scores Measured by Visual Analog Scale
10-cm Visual Analog Scale (VAS), score of 0 no pain to a score of 10 worst pain ever
Time frame: Through study completion, assessed at 1h, 2h, 4h, 6h, 12h and 24h post operatively, then every 24 hours until discharge, and at the post operative visit which occurred within 21-days post-operatively.
Population: Patients were discharged at different times post operatively, dependent on the procedure performed and post operative pain management. Some patients were discharged before 24 hours post operatively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment Group | Difference in Post-operative Pain Scores Measured by Visual Analog Scale | Pain 1 hour post operative | 5.5 score on a scale | Standard Deviation 2.8 |
| Treatment Group | Difference in Post-operative Pain Scores Measured by Visual Analog Scale | Pain 48 hours post operative | 2.5 score on a scale | Standard Deviation 2.5 |
| Treatment Group | Difference in Post-operative Pain Scores Measured by Visual Analog Scale | Pain 72 hours post operative | 5 score on a scale | Standard Deviation 0 |
| Treatment Group | Difference in Post-operative Pain Scores Measured by Visual Analog Scale | Pain 96 hours post operative | 6 score on a scale | Standard Deviation 0 |
| Treatment Group | Difference in Post-operative Pain Scores Measured by Visual Analog Scale | Pain 120 hours post operative | 5 score on a scale | Standard Deviation 0 |
| Treatment Group | Difference in Post-operative Pain Scores Measured by Visual Analog Scale | Pain on discharge | 1 score on a scale | Standard Deviation 1 |
| Treatment Group | Difference in Post-operative Pain Scores Measured by Visual Analog Scale | Pain at post operative visit | 0.5 score on a scale | Standard Deviation 1.2 |
| Treatment Group | Difference in Post-operative Pain Scores Measured by Visual Analog Scale | Pain 2 hours post operative | 4.4 score on a scale | Standard Deviation 3.4 |
| Treatment Group | Difference in Post-operative Pain Scores Measured by Visual Analog Scale | Pain 4 hours post operative | 4.8 score on a scale | Standard Deviation 3.2 |
| Treatment Group | Difference in Post-operative Pain Scores Measured by Visual Analog Scale | Pain 6 hours post operative | 4.0 score on a scale | Standard Deviation 2.1 |
| Treatment Group | Difference in Post-operative Pain Scores Measured by Visual Analog Scale | Pain 12 hours post operative | 3.6 score on a scale | Standard Deviation 2.8 |
| Treatment Group | Difference in Post-operative Pain Scores Measured by Visual Analog Scale | Pain 24 hours post operative | 2.3 score on a scale | Standard Deviation 1.7 |
| Control Group | Difference in Post-operative Pain Scores Measured by Visual Analog Scale | Pain 1 hour post operative | 4.0 score on a scale | Standard Deviation 2.4 |
| Control Group | Difference in Post-operative Pain Scores Measured by Visual Analog Scale | Pain 2 hours post operative | 4.2 score on a scale | Standard Deviation 1.5 |
| Control Group | Difference in Post-operative Pain Scores Measured by Visual Analog Scale | Pain 12 hours post operative | 2.4 score on a scale | Standard Deviation 1.6 |
| Control Group | Difference in Post-operative Pain Scores Measured by Visual Analog Scale | Pain 6 hours post operative | 2.5 score on a scale | Standard Deviation 2 |
| Control Group | Difference in Post-operative Pain Scores Measured by Visual Analog Scale | Pain 24 hours post operative | 1.9 score on a scale | Standard Deviation 1.9 |
| Control Group | Difference in Post-operative Pain Scores Measured by Visual Analog Scale | Pain on discharge | 2 score on a scale | Standard Deviation 0 |
| Control Group | Difference in Post-operative Pain Scores Measured by Visual Analog Scale | Pain 48 hours post operative | 2 score on a scale | Standard Deviation 0 |
| Control Group | Difference in Post-operative Pain Scores Measured by Visual Analog Scale | Pain 4 hours post operative | 3.1 score on a scale | Standard Deviation 2.2 |
| Control Group | Difference in Post-operative Pain Scores Measured by Visual Analog Scale | Pain at post operative visit | 0.5 score on a scale | Standard Deviation 0.8 |
Secondary
Duration of Post-operative Ileus
Difference in post-operative Ileus duration
Time frame: Through study completion, assessed at 1h, 2h, 4h, 6h, 12h and 24h post operatively, then every 24 hours until discharge, and at the post operative visit which occurred within 21-days post-operatively.
Population: Patients were discharged mostly within 48 hours post operatively, and post operative follow up was not successful. This is not a reliable result.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Treatment Group | Duration of Post-operative Ileus | Total patients recorded with returned ileus at 6 hours postop | 0 Participants |
| Treatment Group | Duration of Post-operative Ileus | Total patients recorded with returned ileus at 48h postop | 1 Participants |
| Treatment Group | Duration of Post-operative Ileus | Total patients recorded with returned ileus at 4 hours postop | 0 Participants |
| Treatment Group | Duration of Post-operative Ileus | Total patients recorded with returned ileus at 72 hours postop | 1 Participants |
| Treatment Group | Duration of Post-operative Ileus | Total patients recorded with returned ileus at 12 hours postop | 0 Participants |
| Treatment Group | Duration of Post-operative Ileus | Total patients recorded with returned ileus at 96 hours postop | 0 Participants |
| Treatment Group | Duration of Post-operative Ileus | Total patients recorded with returned ileus at 2 hours postop | 0 Participants |
| Treatment Group | Duration of Post-operative Ileus | Total patients recorded with returned ileus at 120 hours postop | 0 Participants |
| Treatment Group | Duration of Post-operative Ileus | Total patients recorded with returned ileus at 24 hours postop | 0 Participants |
| Treatment Group | Duration of Post-operative Ileus | Total patients who did not have returned ileus on discharge | 9 Participants |
| Treatment Group | Duration of Post-operative Ileus | Total patients recorded with returned ileus at 1 hour postop | 0 Participants |
| Control Group | Duration of Post-operative Ileus | Total patients who did not have returned ileus on discharge | 9 Participants |
| Control Group | Duration of Post-operative Ileus | Total patients recorded with returned ileus at 1 hour postop | 0 Participants |
| Control Group | Duration of Post-operative Ileus | Total patients recorded with returned ileus at 2 hours postop | 0 Participants |
| Control Group | Duration of Post-operative Ileus | Total patients recorded with returned ileus at 4 hours postop | 0 Participants |
| Control Group | Duration of Post-operative Ileus | Total patients recorded with returned ileus at 6 hours postop | 0 Participants |
| Control Group | Duration of Post-operative Ileus | Total patients recorded with returned ileus at 12 hours postop | 0 Participants |
| Control Group | Duration of Post-operative Ileus | Total patients recorded with returned ileus at 24 hours postop | 1 Participants |
| Control Group | Duration of Post-operative Ileus | Total patients recorded with returned ileus at 48h postop | 0 Participants |
| Control Group | Duration of Post-operative Ileus | Total patients recorded with returned ileus at 72 hours postop | 0 Participants |
| Control Group | Duration of Post-operative Ileus | Total patients recorded with returned ileus at 96 hours postop | 0 Participants |
| Control Group | Duration of Post-operative Ileus | Total patients recorded with returned ileus at 120 hours postop | 0 Participants |
Secondary
First Ambulation in the Hallway
Difference in time to first ambulation in the hallway after surgery
Time frame: During hospitalization at 1h, 2h, 4h, 6h, 12h, and 24h post operatively, then every 24 hours until discharge.
Population: Number of patients ambulated at 1h, 2h, 4h, 6h, 12h, 24h post-operatively, then recorded every 24h until discharge.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Treatment Group | First Ambulation in the Hallway | Ambulated 6 hours post operatively | 1 Participants |
| Treatment Group | First Ambulation in the Hallway | Ambulated 12 hours post operatively | 3 Participants |
| Treatment Group | First Ambulation in the Hallway | Ambulated 24 hours post operatively | 3 Participants |
| Treatment Group | First Ambulation in the Hallway | Ambulated 48 hours post operatively | 0 Participants |
| Treatment Group | First Ambulation in the Hallway | Ambulated 72 hours post operatively | 0 Participants |
| Treatment Group | First Ambulation in the Hallway | Patients who only ambulated at discharge | 0 Participants |
| Treatment Group | First Ambulation in the Hallway | Patients who did not ambulate by discharge | 2 Participants |
| Treatment Group | First Ambulation in the Hallway | Patients not recorded | 2 Participants |
| Control Group | First Ambulation in the Hallway | Patients not recorded | 0 Participants |
| Control Group | First Ambulation in the Hallway | Ambulated 6 hours post operatively | 0 Participants |
| Control Group | First Ambulation in the Hallway | Ambulated 72 hours post operatively | 0 Participants |
| Control Group | First Ambulation in the Hallway | Ambulated 12 hours post operatively | 1 Participants |
| Control Group | First Ambulation in the Hallway | Patients who did not ambulate by discharge | 2 Participants |
| Control Group | First Ambulation in the Hallway | Ambulated 24 hours post operatively | 6 Participants |
| Control Group | First Ambulation in the Hallway | Patients who only ambulated at discharge | 1 Participants |
| Control Group | First Ambulation in the Hallway | Ambulated 48 hours post operatively | 0 Participants |
Secondary
Length of Hospital Stay
Difference in length of hospital stay determined by surgeon excluding social factors that may delay discharge
Time frame: At participant discharge, assessed up to 14 days (+/-) 7 days
Population: Patients were discharged at different times, dependent on post operative recovery and pain management.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Treatment Group | Length of Hospital Stay | Discharged within 24 hours | 1 Participants |
| Treatment Group | Length of Hospital Stay | Discharged between 24 and 48 hours | 6 Participants |
| Treatment Group | Length of Hospital Stay | Discharged between 48 and 72 hours | 3 Participants |
| Treatment Group | Length of Hospital Stay | Discharged between 72 and 96 hours | 0 Participants |
| Treatment Group | Length of Hospital Stay | Discharged between 96 and 120 hours | 0 Participants |
| Treatment Group | Length of Hospital Stay | Discharged between 120 and 144 hours | 1 Participants |
| Control Group | Length of Hospital Stay | Discharged between 96 and 120 hours | 0 Participants |
| Control Group | Length of Hospital Stay | Discharged within 24 hours | 2 Participants |
| Control Group | Length of Hospital Stay | Discharged between 72 and 96 hours | 0 Participants |
| Control Group | Length of Hospital Stay | Discharged between 24 and 48 hours | 7 Participants |
| Control Group | Length of Hospital Stay | Discharged between 120 and 144 hours | 0 Participants |
| Control Group | Length of Hospital Stay | Discharged between 48 and 72 hours | 1 Participants |
Secondary
Opioid Consumption
Difference in opioid consumption in first 24 hours, discharge and 21 days post-operatively (morphine equivalents)
Time frame: Through study completion, assessed for first 24-hours post operatively, then every 24 hours until discharge, and at the post operative visit which occurred within 21-days post-operatively.
Population: The milligram morphine equivalent for oral opioid use is reported per group for 24h postop, 25-48h postop, 49-72h postop, 73-96h postop, and 97-120h postop.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment Group | Opioid Consumption | Milligram morphine equivalent (MME) 0-24h postop | 22.5 Milligram Morphine Equivalent | Standard Deviation 19.4 |
| Treatment Group | Opioid Consumption | Milligram morphine equivalent (MME) 73-96h postop | 7.5 Milligram Morphine Equivalent | Standard Deviation 0 |
| Treatment Group | Opioid Consumption | Milligram morphine equivalent (MME) 97-120h postop | 7.5 Milligram Morphine Equivalent | Standard Deviation 0 |
| Treatment Group | Opioid Consumption | Milligram morphine equivalent (MME) prescribed at discharge for home use | 26.8 Milligram Morphine Equivalent | Standard Deviation 13.8 |
| Treatment Group | Opioid Consumption | Milligram morphine equivalent (MME) used of discharge prescription | 20.0 Milligram Morphine Equivalent | Standard Deviation 22.6 |
| Treatment Group | Opioid Consumption | Milligram morphine equivalent (MME) 25-48h postop | 26.3 Milligram Morphine Equivalent | Standard Deviation 19.8 |
| Treatment Group | Opioid Consumption | Milligram morphine equivalent (MME) 49-72h postop | 7.5 Milligram Morphine Equivalent | Standard Deviation 0 |
| Control Group | Opioid Consumption | Milligram morphine equivalent (MME) 0-24h postop | 12.0 Milligram Morphine Equivalent | Standard Deviation 5.4 |
| Control Group | Opioid Consumption | Milligram morphine equivalent (MME) used of discharge prescription | 8.8 Milligram Morphine Equivalent | Standard Deviation 12 |
| Control Group | Opioid Consumption | Milligram morphine equivalent (MME) prescribed at discharge for home use | 23.0 Milligram Morphine Equivalent | Standard Deviation 7.5 |
| Control Group | Opioid Consumption | Milligram morphine equivalent (MME) 25-48h postop | 21.3 Milligram Morphine Equivalent | Standard Deviation 1.8 |
Secondary
Post-operative PACU Time
Difference in time in the Post Anesthesia Care Unit (PACU) after surgery
Time frame: During hospitalization, approximately 2 hours post-surgery
Population: Data were not captured for 9 patients in the treatment group and 8 patients in the control group.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment Group | Post-operative PACU Time | 59 Minutes | Standard Deviation 7.8 |
| Control Group | Post-operative PACU Time | 122.5 Minutes | Standard Deviation 53 |
Secondary
Return of Flatus
Difference in return of flatus after surgery
Time frame: During hospitalization at 1h, 2h, 4h, 6h, 12h, and 24h post operatively, then every 24 hours thereafter until discharge.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Treatment Group | Return of Flatus | Return of flatus 4 hours post operative | 1 Participants |
| Treatment Group | Return of Flatus | Return of flatus 12 hours post operative | 5 Participants |
| Treatment Group | Return of Flatus | Return of flatus 6 hours post operative | 1 Participants |
| Treatment Group | Return of Flatus | Return of flatus 24 hours post operative | 4 Participants |
| Treatment Group | Return of Flatus | Return of flatus 2 hours post operative | 0 Participants |
| Control Group | Return of Flatus | Return of flatus 24 hours post operative | 5 Participants |
| Control Group | Return of Flatus | Return of flatus 2 hours post operative | 1 Participants |
| Control Group | Return of Flatus | Return of flatus 4 hours post operative | 0 Participants |
| Control Group | Return of Flatus | Return of flatus 6 hours post operative | 2 Participants |
| Control Group | Return of Flatus | Return of flatus 12 hours post operative | 2 Participants |
Secondary
Time to Out of Bed
Difference in time to out of bed to chair after surgery
Time frame: During hospitalization regular intervals for the first 24 hours, then every 24 hours until discharge.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Treatment Group | Time to Out of Bed | Out of bed to chair 48 hours post operative | 2 Participants |
| Treatment Group | Time to Out of Bed | Out of bed to chair 4 hours post operative | 0 Participants |
| Treatment Group | Time to Out of Bed | Patients not recorded | 3 Participants |
| Treatment Group | Time to Out of Bed | Out of bed to chair 6 hours post operative | 1 Participants |
| Treatment Group | Time to Out of Bed | Patients out of bed to chair only at discharge | 0 Participants |
| Treatment Group | Time to Out of Bed | Out of bed to chair 12 hours post operative | 2 Participants |
| Treatment Group | Time to Out of Bed | Out of bed to chair 2 hours post operative | 0 Participants |
| Treatment Group | Time to Out of Bed | Out of bed to chair 24 hours post operative | 3 Participants |
| Control Group | Time to Out of Bed | Out of bed to chair 2 hours post operative | 1 Participants |
| Control Group | Time to Out of Bed | Out of bed to chair 48 hours post operative | 0 Participants |
| Control Group | Time to Out of Bed | Patients out of bed to chair only at discharge | 1 Participants |
| Control Group | Time to Out of Bed | Patients not recorded | 1 Participants |
| Control Group | Time to Out of Bed | Out of bed to chair 24 hours post operative | 5 Participants |
| Control Group | Time to Out of Bed | Out of bed to chair 4 hours post operative | 0 Participants |
| Control Group | Time to Out of Bed | Out of bed to chair 6 hours post operative | 1 Participants |
| Control Group | Time to Out of Bed | Out of bed to chair 12 hours post operative | 1 Participants |