Total Knee Athroplasty
Conditions
Keywords
TKA, PAI, ACB, IPACK, Knee Arthroplasty
Brief summary
The goal of this clinical trial is to determine whether Periarticular Injection (PAI) alongside Adductor Canal Block (ACB) and Infiltration between the Popliteal Artery and Capsule of the Knee (IPACK) block can decrease post-operative pain in patients undergoing primary total knee arthroplasty. The main question it aims to answer is: • Is ACB/IPACK without PAI as effective as ACB/IPACK with PAI for TKA patients? Participants will be assigned to one of the following groups at random: * ACB/PACK with PAI * ACB/IPACK with saline injection Participants will also be asked to complete pre- and post-operative questionnaires.
Detailed description
Kim et al (2019) have shown that addition of ACB/IPACK to PAI improves analgesic outcomes (the nerve blocks reduced pain with ambulation and reduced opioid consumption). TKA patients receiving PAI + ACB/IPACK (along with a comprehensive multimodal analgesic program) had low pain scores with ambulation on POD1: 1.7 +/- 1.4 (mean +/- SD, NRS, 0-10 scale). The opioid consumption in the first 24 hours was 40.6 +/- 32.1 (mg oral morphine equivalents). It is not clear if the PAI component is necessary, given the theoretically nearly complete analgesic effects of the ACB/IPACK block. Additionally, anecdotal evidence indicates that some surgeons at HSS routinely use the PAI and some do not, without obvious large differences in analgesic outcomes. While there may be a 'belt and suspenders' advantage to using PAI in addition to ACB/IPACK, it is not desirable to perform unnecessary procedures. In this study, we seek to compare the efficacy of ACB/IPACK with and without PAI in TKA patients.
Interventions
PAI is a widely-utilized, surgeon-performed, analgesic intervention for TKA patients.
DRUGSaline Control Periarticular Injection (PAI)
equal volume of saline will be used in place of analgesics used in PAI injections
Sponsors
Hospital for Special Surgery, New York
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
25 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Planned use of regional anesthesia * Ability to follow the major components of the study protocol * English speaking (Secondary outcomes include questionnaires validated in English only)
Exclusion criteria
* Patients younger than 25 years old and older than 80 * Non-English speaking * Patients intending to receive general anesthesia * Contraindication to nerve blocks or peri-articular injection * Patients with an ASA of IV or higher * Renal insufficiency (ESRD, HD, estimated creatinine clearance \< 30 ml/min) * Patients with major prior ipsilateral open knee surgery * Chronic gabapentin/pregabalin use (regular use for longer than 3 months) * Chronic opioid use (taking opioids for longer than 3 months)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Scores (NRS, 0-10) With Ambulation on POD1 | 24 hours Post Operative Discharge | The NRS (numeric rating scale) is a questionnaire that measures pain on a numeric scale, 0 (no pain) to 10 (worst pain imaginable). The questionnaire will be asked on post operative discharge day 1. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| NRS Pain With Movement | pre-operation, in the post anesthesia care unit (PACU), at post operative (POD) 1, POD 2, and POD 3 months | The NRS (numeric rating scale) is a questionnaire that measures pain on a numeric scale, 0 (no pain) to 10 (worst pain imaginable). The questionnaire will focus on pain during movement and will be asked at pre-operation, in the post anesthesia care unit (PACU), at post operative (POD) 1, POD 2, and POD 3 months. |
| Numerical Rating Scale (NRS) Pain Score at Rest | from pre-operation, post anesthesia care unit (PACU), post operative day (POD) 1, POD 2, and POD 3 months | The NRS (numeric rating scale) is a questionnaire that measures pain on a numeric scale, 0 (no pain) to 10 (worst pain imaginable). The questionnaire will focus on pain without movement involved and will be asked at pre-operation, post anesthesia care unit (PACU), post operative day (POD) 1, POD 2, and POD 3 months |
| PAIN OUT Questionnaire at Preoperation | at preoperation | The PAIN OUT questionnaire has multiple numeric scale questions on pain relief as well as pain intensity, along with Yes/No questions. There are also questions asking which pain relief techniques were used (multiple choice). All questions are scored on a scale of 0 to 10, with 0 meaning no pain/does not interfere/not at all and 10 meaning worst pain/completely interferes/extremely. A higher score means a worse outcome. |
| Quality of Recovery (POD1) | 24 hours post surgical discharge. | Quality of Recovery (QoR-9), This questionnaire has three options for scale (not at all, some of the time, most of the time). The QoR-9 is a nine-item scale. Total QoR-9-scores range from 0 to 18, with higher scores indicating good recovery after anaesthesia. The questions focus on the overall well being of the patient. The questionnaire will be asked 24 hours post surgical discharge. |
| Side Effects: Opioid-Related Symptom Distress Score (POD1) | 24 hours (POD 1) post surgical discharge. | The Opioid-related symptom distress scale evaluates frequency, severity, bothersomeness for 12 symptoms. Each symptom is scored on a 4-point scale, with 0 meaning better outcome and 4 meaning worst outcome. The questionnaire will be asked 24 hours (POD 1) post surgical discharge. |
| Satisfaction With Pain Management (POD1) | 24 hours post operative discharge. | This questionnaire is a numeric scale from 0 (strongly dissatisfied) to 10 ( strongly satisfied). A higher number dictates a better outcome. This will be asked 24 hours post operative discharge. |
| Blinding Assessment; Bang Question (POD1) | 24 hours post operative discharge | There is no numeric scale for this questionnaire. It focuses on asking the subjects and the research assistant, which group they believe the subject were randomized to. This will be asked 24 hours post operative discharge. |
| Douleur Neuropathique en 4 Questions (DN4) at Pre-operation, 3 Months | Pre operative, 3 months post operative discharge. | The DN4 ( Douleur Neuropathique en 4 Questions) is a Yes/No questionnaire aimed at uncovering neuropathic pain symptoms. Each question is scored as yes or no, with yes = 1 point and no = 0 points. Total score is calculated by summing the total of the individual question scores, for a total score range of 0-10, with a score of greater than or equal to 4 indicating the patient may be suffering from neuropathic pain. The average score across all participants is calculated and reported for each time point. |
| Opioid Use (Cumulative Oral Morphine Equivalents POD0-POD2, 2 Weeks, 3 Months) | post surgical discharge, 24 hours post surgical discharge, 48 hours post surgical discharge, 2 weeks post surgical discharge, and 3 months post surgical discharge. | Cumulative opioid consumption in morphine equivalents will be recorded post surgical discharge, 24h post surgical discharge, 48 hours post surgical discharge, 2 weeks post surgical discharge, and 3 months post surgical discharge. |
| PAIN OUT Questionnaire at Post Operative Day (POD) 1 | at post operative day (POD) 1 | The PAIN OUT questionnaire has multiple numeric scale questions on pain relief as well as pain intensity, along with Yes/No questions. There are also questions asking which pain relief techniques were used (multiple choice). All questions are scored on a scale of 0 to 10, with 0 meaning no pain/does not interfere/not at all and 10 meaning worst pain/completely interferes/extremely. A higher score means a worse outcome. |
| PAIN OUT Questionnaire at Post Operative Day (POD) 14 | at post operative day (POD) 14 | The PAIN OUT questionnaire has multiple numeric scale questions on pain relief as well as pain intensity, along with Yes/No questions. There are also questions asking which pain relief techniques were used (multiple choice). All questions are scored on a scale of 0 to 10, with 0 meaning no pain/does not interfere/not at all and 10 meaning worst pain/completely interferes/extremely. A higher score means a worse outcome. |
| PAIN OUT Questionnaire at Post Operative Day (POD) 90 | at post operative day (POD) 90 | The PAIN OUT questionnaire has multiple numeric scale questions on pain relief as well as pain intensity, along with Yes/No questions. There are also questions asking which pain relief techniques were used (multiple choice). All questions are scored on a scale of 0 to 10, with 0 meaning no pain/does not interfere/not at all and 10 meaning worst pain/completely interferes/extremely. A higher score means a worse outcome. |
| PAIN OUT Questionnaire at Preoperation / Percentage of Time in Severe Pain and Pain Relief | at preoperation | The PAIN OUT questionnaire has multiple numeric scale questions on pain relief as well as pain intensity, along with Yes/No questions. There are also questions asking which pain relief techniques were used (multiple choice). All questions are scored on a scale of 0 to 10, with 0 meaning no pain/does not interfere/not at all and 10 meaning worst pain/completely interferes/extremely. A higher score means a worse outcome. This outcome records the percentage of time in severe pain and percentage pain relief, both scored from 0% to 100%. |
| PAIN OUT Questionnaire at Post Operative Day (POD) 1 / Percentage of Time in Severe Pain and Pain Relief | at post operative day (POD) 1 | The PAIN OUT questionnaire has multiple numeric scale questions on pain relief as well as pain intensity, along with Yes/No questions. There are also questions asking which pain relief techniques were used (multiple choice). All questions are scored on a scale of 0 to 10, with 0 meaning no pain/does not interfere/not at all and 10 meaning worst pain/completely interferes/extremely. A higher score means a worse outcome. This outcome records the percentage of time in severe pain and percentage pain relief, both scored from 0% to 100%. |
| PAIN OUT Questionnaire at Post Operative Day (POD) 14 / Percentage of Time in Severe Pain and Pain Relief | at post operative day (POD) 14 | The PAIN OUT questionnaire has multiple numeric scale questions on pain relief as well as pain intensity, along with Yes/No questions. There are also questions asking which pain relief techniques were used (multiple choice). All questions are scored on a scale of 0 to 10, with 0 meaning no pain/does not interfere/not at all and 10 meaning worst pain/completely interferes/extremely. A higher score means a worse outcome. This outcome records the percentage of time in severe pain and percentage pain relief, both scored from 0% to 100%. |
| PAIN OUT Questionnaire at Post Operative Day (POD) 90 / Percentage of Time in Severe Pain and Pain Relief | at post operative day (POD) 90 | The PAIN OUT questionnaire has multiple numeric scale questions on pain relief as well as pain intensity, along with Yes/No questions. There are also questions asking which pain relief techniques were used (multiple choice). All questions are scored on a scale of 0 to 10, with 0 meaning no pain/does not interfere/not at all and 10 meaning worst pain/completely interferes/extremely. A higher score means a worse outcome. This outcome records the percentage of time in severe pain and percentage pain relief, both scored from 0% to 100%. |
| Knee Injury and Osteoarthritis Outcome Score for Joint Replacement | preoperatively, 6 weeks post operative discharge, 3 months post operative discharge | The standard Knee injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS Jr.) questionnaire will be asked to evaluate orthopedic outcomes. The KOOS, JR contains 7 items from the original KOOS survey. Items are coded from 0 to 4, none to extreme respectively. KOOS, JR is scored by summing the raw response (range 0-28) and then converting it to an interval score. The interval score ranges from 0 to 100 where 0 represents total knee disability and 100 represents perfect knee health. The questionnaire will be asked preoperatively, 6 weeks post operative discharge, 3 months post operative discharge. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| No PAI + ACB & IPACK Control: saline injection (same injection technique and volumes as described for the active intervention, of normal saline)
Saline Control Periarticular Injection (PAI): equal volume of saline will be used in place of analgesics used in PAI injections | 47 |
| PAI + ACB & IPACK Active intervention: Periarticular injection: one deep injection prior to cementation and then a second more superficial injection prior to closure. The deep injection will consist of bupivacaine 0.25% with 1:200,000 epinephrine, 30 cc; morphine, 8 mg/ml, 1cc; methylprednisolone, 40 mg/ml, 1 ml; cefazolin, 500 in 10 ml; normal saline, 22cc. The superficial injection will be 20 ml 0.25% bupivacaine
Periarticular Injection (PAI): PAI is a widely-utilized, surgeon-performed, analgesic intervention for TKA patients. | 47 |
| Total | 94 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 6 | 10 |
Baseline characteristics
| Characteristic | Total | PAI + ACB & IPACK | No PAI + ACB & IPACK |
|---|---|---|---|
| Age, Continuous | 66 years STANDARD_DEVIATION 6 | 66 years STANDARD_DEVIATION 7 | 67 years STANDARD_DEVIATION 6 |
| American Society of Anesthesiologists Status ASA 1 | 6 Participants | 1 Participants | 5 Participants |
| American Society of Anesthesiologists Status ASA 2 | 85 Participants | 46 Participants | 39 Participants |
| American Society of Anesthesiologists Status ASA 3 | 3 Participants | 0 Participants | 3 Participants |
| Body Mass Index | 30 kg/m^2 STANDARD_DEVIATION 4 | 31 kg/m^2 STANDARD_DEVIATION 4 | 30 kg/m^2 STANDARD_DEVIATION 3 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 11 Participants | 8 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 83 Participants | 39 Participants | 44 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 10 Participants | 4 Participants | 6 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 | 2 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) White | 81 Participants | 42 Participants | 39 Participants |
| Sex: Female, Male Female | 43 Participants | 22 Participants | 21 Participants |
| Sex: Female, Male Male | 51 Participants | 25 Participants | 26 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 47 | 0 / 47 |
| other Total, other adverse events | 0 / 47 | 0 / 47 |
| serious Total, serious adverse events | 1 / 47 | 2 / 47 |
Outcome results
Primary
Pain Scores (NRS, 0-10) With Ambulation on POD1
The NRS (numeric rating scale) is a questionnaire that measures pain on a numeric scale, 0 (no pain) to 10 (worst pain imaginable). The questionnaire will be asked on post operative discharge day 1.
Time frame: 24 hours Post Operative Discharge
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| No PAI + ACB & IPACK | Pain Scores (NRS, 0-10) With Ambulation on POD1 | 4.55 units on a scale | Standard Deviation 2.7 |
| PAI + ACB & IPACK | Pain Scores (NRS, 0-10) With Ambulation on POD1 | 4.26 units on a scale | Standard Deviation 3.03 |
p-value: 0.11t-test, 1 sided
Secondary
Blinding Assessment; Bang Question (POD1)
There is no numeric scale for this questionnaire. It focuses on asking the subjects and the research assistant, which group they believe the subject were randomized to. This will be asked 24 hours post operative discharge.
Time frame: 24 hours post operative discharge
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| No PAI + ACB & IPACK | Blinding Assessment; Bang Question (POD1) | Research Assistant Guess | Guessed Don't know | 43 Participants |
| No PAI + ACB & IPACK | Blinding Assessment; Bang Question (POD1) | Subjects Guess | Guessed that the subject was in the No PAI+ACB & IPACK group | 10 Participants |
| No PAI + ACB & IPACK | Blinding Assessment; Bang Question (POD1) | Subjects Guess | Guessed that the subject was in the PAI+ACB & IPACK group | 13 Participants |
| No PAI + ACB & IPACK | Blinding Assessment; Bang Question (POD1) | Subjects Guess | Guessed Don't know | 24 Participants |
| No PAI + ACB & IPACK | Blinding Assessment; Bang Question (POD1) | Research Assistant Guess | Guessed that the subject was in the No PAI+ACB & IPACK group | 0 Participants |
| No PAI + ACB & IPACK | Blinding Assessment; Bang Question (POD1) | Research Assistant Guess | Guessed that the subject was in the PAI+ACB & IPACK group | 4 Participants |
| PAI + ACB & IPACK | Blinding Assessment; Bang Question (POD1) | Research Assistant Guess | Guessed that the subject was in the No PAI+ACB & IPACK group | 3 Participants |
| PAI + ACB & IPACK | Blinding Assessment; Bang Question (POD1) | Research Assistant Guess | Guessed Don't know | 37 Participants |
| PAI + ACB & IPACK | Blinding Assessment; Bang Question (POD1) | Subjects Guess | Guessed Don't know | 22 Participants |
| PAI + ACB & IPACK | Blinding Assessment; Bang Question (POD1) | Subjects Guess | Guessed that the subject was in the No PAI+ACB & IPACK group | 8 Participants |
| PAI + ACB & IPACK | Blinding Assessment; Bang Question (POD1) | Research Assistant Guess | Guessed that the subject was in the PAI+ACB & IPACK group | 7 Participants |
| PAI + ACB & IPACK | Blinding Assessment; Bang Question (POD1) | Subjects Guess | Guessed that the subject was in the PAI+ACB & IPACK group | 17 Participants |
Secondary
Douleur Neuropathique en 4 Questions (DN4) at Pre-operation, 3 Months
The DN4 ( Douleur Neuropathique en 4 Questions) is a Yes/No questionnaire aimed at uncovering neuropathic pain symptoms. Each question is scored as yes or no, with yes = 1 point and no = 0 points. Total score is calculated by summing the total of the individual question scores, for a total score range of 0-10, with a score of greater than or equal to 4 indicating the patient may be suffering from neuropathic pain. The average score across all participants is calculated and reported for each time point.
Time frame: Pre operative, 3 months post operative discharge.
Population: The number analyzed at POD 3 months differs from the overall number of participant due to lost to follow up.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| No PAI + ACB & IPACK | Douleur Neuropathique en 4 Questions (DN4) at Pre-operation, 3 Months | at peroperation | 2.79 score on a scale | Standard Deviation 1.35 |
| No PAI + ACB & IPACK | Douleur Neuropathique en 4 Questions (DN4) at Pre-operation, 3 Months | post operative day (POD) 3 months | 2.63 score on a scale | Standard Deviation 0.92 |
| PAI + ACB & IPACK | Douleur Neuropathique en 4 Questions (DN4) at Pre-operation, 3 Months | at peroperation | 2.62 score on a scale | Standard Deviation 1.11 |
| PAI + ACB & IPACK | Douleur Neuropathique en 4 Questions (DN4) at Pre-operation, 3 Months | post operative day (POD) 3 months | 2.78 score on a scale | Standard Deviation 0.92 |
Secondary
Knee Injury and Osteoarthritis Outcome Score for Joint Replacement
The standard Knee injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS Jr.) questionnaire will be asked to evaluate orthopedic outcomes. The KOOS, JR contains 7 items from the original KOOS survey. Items are coded from 0 to 4, none to extreme respectively. KOOS, JR is scored by summing the raw response (range 0-28) and then converting it to an interval score. The interval score ranges from 0 to 100 where 0 represents total knee disability and 100 represents perfect knee health. The questionnaire will be asked preoperatively, 6 weeks post operative discharge, 3 months post operative discharge.
Time frame: preoperatively, 6 weeks post operative discharge, 3 months post operative discharge
Population: The number analyzed at 6 weeks and 3 months differ from the overall number due to lost to follow up
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| No PAI + ACB & IPACK | Knee Injury and Osteoarthritis Outcome Score for Joint Replacement | at preoperation | 50.7 score on a scale | Standard Deviation 16.2 |
| No PAI + ACB & IPACK | Knee Injury and Osteoarthritis Outcome Score for Joint Replacement | at 6 weeks | 78.31 score on a scale | Standard Deviation 11.36 |
| No PAI + ACB & IPACK | Knee Injury and Osteoarthritis Outcome Score for Joint Replacement | at 3 months | 83.39 score on a scale | Standard Deviation 13.83 |
| PAI + ACB & IPACK | Knee Injury and Osteoarthritis Outcome Score for Joint Replacement | at preoperation | 49.61 score on a scale | Standard Deviation 16.57 |
| PAI + ACB & IPACK | Knee Injury and Osteoarthritis Outcome Score for Joint Replacement | at 6 weeks | 77.05 score on a scale | Standard Deviation 12.86 |
| PAI + ACB & IPACK | Knee Injury and Osteoarthritis Outcome Score for Joint Replacement | at 3 months | 83.60 score on a scale | Standard Deviation 9.57 |
Secondary
NRS Pain With Movement
The NRS (numeric rating scale) is a questionnaire that measures pain on a numeric scale, 0 (no pain) to 10 (worst pain imaginable). The questionnaire will focus on pain during movement and will be asked at pre-operation, in the post anesthesia care unit (PACU), at post operative (POD) 1, POD 2, and POD 3 months.
Time frame: pre-operation, in the post anesthesia care unit (PACU), at post operative (POD) 1, POD 2, and POD 3 months
Population: the number of participants analyzed at POD 3 months is different due to lost to follow ups
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| No PAI + ACB & IPACK | NRS Pain With Movement | Post anesthesia care unit (PACU) | 5.7 units on a scale | Standard Deviation 3.11 |
| No PAI + ACB & IPACK | NRS Pain With Movement | Post operative day (POD) 2 | 6.68 units on a scale | Standard Deviation 2.29 |
| No PAI + ACB & IPACK | NRS Pain With Movement | Post operative day (POD) 1 | 4.55 units on a scale | Standard Deviation 2.7 |
| No PAI + ACB & IPACK | NRS Pain With Movement | Post operative day (POD) 3 months | 1.02 units on a scale | Standard Deviation 1.82 |
| No PAI + ACB & IPACK | NRS Pain With Movement | Pre-operation | 5.17 units on a scale | Standard Deviation 2.52 |
| PAI + ACB & IPACK | NRS Pain With Movement | Post operative day (POD) 3 months | 0.95 units on a scale | Standard Deviation 1.47 |
| PAI + ACB & IPACK | NRS Pain With Movement | Pre-operation | 5.85 units on a scale | Standard Deviation 2.62 |
| PAI + ACB & IPACK | NRS Pain With Movement | Post anesthesia care unit (PACU) | 5.19 units on a scale | Standard Deviation 2.92 |
| PAI + ACB & IPACK | NRS Pain With Movement | Post operative day (POD) 1 | 4.26 units on a scale | Standard Deviation 3.03 |
| PAI + ACB & IPACK | NRS Pain With Movement | Post operative day (POD) 2 | 6.13 units on a scale | Standard Deviation 2.62 |
Secondary
Numerical Rating Scale (NRS) Pain Score at Rest
The NRS (numeric rating scale) is a questionnaire that measures pain on a numeric scale, 0 (no pain) to 10 (worst pain imaginable). The questionnaire will focus on pain without movement involved and will be asked at pre-operation, post anesthesia care unit (PACU), post operative day (POD) 1, POD 2, and POD 3 months
Time frame: from pre-operation, post anesthesia care unit (PACU), post operative day (POD) 1, POD 2, and POD 3 months
Population: number of participants analyzed at POD 3 months differed from overall number of participants due to lost to follow up
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| No PAI + ACB & IPACK | Numerical Rating Scale (NRS) Pain Score at Rest | pre-operation | 1.19 units on a scale | Standard Deviation 2.05 |
| No PAI + ACB & IPACK | Numerical Rating Scale (NRS) Pain Score at Rest | post operative day (POD) 1 | 2.36 units on a scale | Standard Deviation 2.29 |
| No PAI + ACB & IPACK | Numerical Rating Scale (NRS) Pain Score at Rest | post anesthesia care unit (PACU) | 5.66 units on a scale | Standard Deviation 3.17 |
| No PAI + ACB & IPACK | Numerical Rating Scale (NRS) Pain Score at Rest | post operative day (POD) 2 | 4.09 units on a scale | Standard Deviation 2.95 |
| No PAI + ACB & IPACK | Numerical Rating Scale (NRS) Pain Score at Rest | post operative day (POD) 3 months | 0.29 units on a scale | Standard Deviation 0.93 |
| PAI + ACB & IPACK | Numerical Rating Scale (NRS) Pain Score at Rest | post operative day (POD) 2 | 4.13 units on a scale | Standard Deviation 3.06 |
| PAI + ACB & IPACK | Numerical Rating Scale (NRS) Pain Score at Rest | post operative day (POD) 3 months | 0.46 units on a scale | Standard Deviation 1.02 |
| PAI + ACB & IPACK | Numerical Rating Scale (NRS) Pain Score at Rest | pre-operation | 1.79 units on a scale | Standard Deviation 2.8 |
| PAI + ACB & IPACK | Numerical Rating Scale (NRS) Pain Score at Rest | post anesthesia care unit (PACU) | 5.06 units on a scale | Standard Deviation 2.91 |
| PAI + ACB & IPACK | Numerical Rating Scale (NRS) Pain Score at Rest | post operative day (POD) 1 | 2.47 units on a scale | Standard Deviation 2.86 |
Secondary
Opioid Use (Cumulative Oral Morphine Equivalents POD0-POD2, 2 Weeks, 3 Months)
Cumulative opioid consumption in morphine equivalents will be recorded post surgical discharge, 24h post surgical discharge, 48 hours post surgical discharge, 2 weeks post surgical discharge, and 3 months post surgical discharge.
Time frame: post surgical discharge, 24 hours post surgical discharge, 48 hours post surgical discharge, 2 weeks post surgical discharge, and 3 months post surgical discharge.
Population: At post operative day 14 and 90, the number analyzed differ from the overall number because some subjects were lost to follow up.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| No PAI + ACB & IPACK | Opioid Use (Cumulative Oral Morphine Equivalents POD0-POD2, 2 Weeks, 3 Months) | post operative day (POD) 1 | 25.95 MME/day | Standard Deviation 20.04 |
| No PAI + ACB & IPACK | Opioid Use (Cumulative Oral Morphine Equivalents POD0-POD2, 2 Weeks, 3 Months) | post operative day (POD) 14 | 6.91 MME/day | Standard Deviation 10.53 |
| No PAI + ACB & IPACK | Opioid Use (Cumulative Oral Morphine Equivalents POD0-POD2, 2 Weeks, 3 Months) | post operative day (POD) 2 | 37.3 MME/day | Standard Deviation 24.86 |
| No PAI + ACB & IPACK | Opioid Use (Cumulative Oral Morphine Equivalents POD0-POD2, 2 Weeks, 3 Months) | post operative day (POD) 90 | 0.27 MME/day | Standard Deviation 1.3 |
| No PAI + ACB & IPACK | Opioid Use (Cumulative Oral Morphine Equivalents POD0-POD2, 2 Weeks, 3 Months) | post anesthesia care unit (PACU) | 25.45 MME/day | Standard Deviation 13.71 |
| PAI + ACB & IPACK | Opioid Use (Cumulative Oral Morphine Equivalents POD0-POD2, 2 Weeks, 3 Months) | post operative day (POD) 90 | 0.2 MME/day | Standard Deviation 1.23 |
| PAI + ACB & IPACK | Opioid Use (Cumulative Oral Morphine Equivalents POD0-POD2, 2 Weeks, 3 Months) | post anesthesia care unit (PACU) | 21.98 MME/day | Standard Deviation 12.02 |
| PAI + ACB & IPACK | Opioid Use (Cumulative Oral Morphine Equivalents POD0-POD2, 2 Weeks, 3 Months) | post operative day (POD) 1 | 22.16 MME/day | Standard Deviation 21.17 |
| PAI + ACB & IPACK | Opioid Use (Cumulative Oral Morphine Equivalents POD0-POD2, 2 Weeks, 3 Months) | post operative day (POD) 2 | 28.64 MME/day | Standard Deviation 30.21 |
| PAI + ACB & IPACK | Opioid Use (Cumulative Oral Morphine Equivalents POD0-POD2, 2 Weeks, 3 Months) | post operative day (POD) 14 | 6.68 MME/day | Standard Deviation 10.4 |
p-value: 0.5t-test, 2 sided
Secondary
PAIN OUT Questionnaire at Post Operative Day (POD) 1
The PAIN OUT questionnaire has multiple numeric scale questions on pain relief as well as pain intensity, along with Yes/No questions. There are also questions asking which pain relief techniques were used (multiple choice). All questions are scored on a scale of 0 to 10, with 0 meaning no pain/does not interfere/not at all and 10 meaning worst pain/completely interferes/extremely. A higher score means a worse outcome.
Time frame: at post operative day (POD) 1
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| No PAI + ACB & IPACK | PAIN OUT Questionnaire at Post Operative Day (POD) 1 | Severity of dizziness | 4.86 score on a scale | Standard Deviation 3.23 |
| No PAI + ACB & IPACK | PAIN OUT Questionnaire at Post Operative Day (POD) 1 | How much the pain caused you to feel depressed | 0 score on a scale | Standard Deviation 0 |
| No PAI + ACB & IPACK | PAIN OUT Questionnaire at Post Operative Day (POD) 1 | Pain interfered or prevented you from activities in bed | 2.32 score on a scale | Standard Deviation 3.85 |
| No PAI + ACB & IPACK | PAIN OUT Questionnaire at Post Operative Day (POD) 1 | How much the pain caused you to feel helpless | .32 score on a scale | Standard Deviation 1.62 |
| No PAI + ACB & IPACK | PAIN OUT Questionnaire at Post Operative Day (POD) 1 | Pain interfered or prevented you from activities out of bed | 3.13 score on a scale | Standard Deviation 3.85 |
| No PAI + ACB & IPACK | PAIN OUT Questionnaire at Post Operative Day (POD) 1 | Severity of nausea | 6 score on a scale | Standard Deviation 3.59 |
| No PAI + ACB & IPACK | PAIN OUT Questionnaire at Post Operative Day (POD) 1 | Least pain in 24 hours | 1.17 score on a scale | Standard Deviation 2.05 |
| No PAI + ACB & IPACK | PAIN OUT Questionnaire at Post Operative Day (POD) 1 | Severity of drowsiness | 6.64 score on a scale | Standard Deviation 2.69 |
| No PAI + ACB & IPACK | PAIN OUT Questionnaire at Post Operative Day (POD) 1 | Pain interfered or prevented you from falling asleep | 1.06 score on a scale | Standard Deviation 2.63 |
| No PAI + ACB & IPACK | PAIN OUT Questionnaire at Post Operative Day (POD) 1 | Severity of itching | 0 score on a scale | Standard Deviation 0 |
| No PAI + ACB & IPACK | PAIN OUT Questionnaire at Post Operative Day (POD) 1 | How much the pain caused you to feel frightened | .32 score on a scale | Standard Deviation 1.62 |
| No PAI + ACB & IPACK | PAIN OUT Questionnaire at Post Operative Day (POD) 1 | Pain interfered or prevented you from staying asleep | 1.19 score on a scale | Standard Deviation 2.84 |
| No PAI + ACB & IPACK | PAIN OUT Questionnaire at Post Operative Day (POD) 1 | Were you allowed to participate in decisions about pain treatment? | 10 score on a scale | Standard Deviation 0 |
| No PAI + ACB & IPACK | PAIN OUT Questionnaire at Post Operative Day (POD) 1 | Worst pain in 24 hours | 6.53 score on a scale | Standard Deviation 2.69 |
| No PAI + ACB & IPACK | PAIN OUT Questionnaire at Post Operative Day (POD) 1 | How satisfied are you with the results of your pain treatment? | 9.78 score on a scale | Standard Deviation 0.68 |
| No PAI + ACB & IPACK | PAIN OUT Questionnaire at Post Operative Day (POD) 1 | How much the pain caused you to feel anxious | .66 score on a scale | Standard Deviation 2.1 |
| PAI + ACB & IPACK | PAIN OUT Questionnaire at Post Operative Day (POD) 1 | How satisfied are you with the results of your pain treatment? | 9.68 score on a scale | Standard Deviation 1.53 |
| PAI + ACB & IPACK | PAIN OUT Questionnaire at Post Operative Day (POD) 1 | How much the pain caused you to feel frightened | .26 score on a scale | Standard Deviation 1.37 |
| PAI + ACB & IPACK | PAIN OUT Questionnaire at Post Operative Day (POD) 1 | Least pain in 24 hours | 1.34 score on a scale | Standard Deviation 2.55 |
| PAI + ACB & IPACK | PAIN OUT Questionnaire at Post Operative Day (POD) 1 | Worst pain in 24 hours | 6.15 score on a scale | Standard Deviation 2.97 |
| PAI + ACB & IPACK | PAIN OUT Questionnaire at Post Operative Day (POD) 1 | Pain interfered or prevented you from activities out of bed | 2.4 score on a scale | Standard Deviation 3.47 |
| PAI + ACB & IPACK | PAIN OUT Questionnaire at Post Operative Day (POD) 1 | Pain interfered or prevented you from falling asleep | .85 score on a scale | Standard Deviation 2.29 |
| PAI + ACB & IPACK | PAIN OUT Questionnaire at Post Operative Day (POD) 1 | Pain interfered or prevented you from staying asleep | .96 score on a scale | Standard Deviation 2.64 |
| PAI + ACB & IPACK | PAIN OUT Questionnaire at Post Operative Day (POD) 1 | How much the pain caused you to feel anxious | .23 score on a scale | Standard Deviation 0.94 |
| PAI + ACB & IPACK | PAIN OUT Questionnaire at Post Operative Day (POD) 1 | How much the pain caused you to feel depressed | .11 score on a scale | Standard Deviation 0.73 |
| PAI + ACB & IPACK | PAIN OUT Questionnaire at Post Operative Day (POD) 1 | How much the pain caused you to feel helpless | 0 score on a scale | Standard Deviation 0 |
| PAI + ACB & IPACK | PAIN OUT Questionnaire at Post Operative Day (POD) 1 | Severity of nausea | 8.57 score on a scale | Standard Deviation 2.9 |
| PAI + ACB & IPACK | PAIN OUT Questionnaire at Post Operative Day (POD) 1 | Severity of drowsiness | 6.72 score on a scale | Standard Deviation 2.91 |
| PAI + ACB & IPACK | PAIN OUT Questionnaire at Post Operative Day (POD) 1 | Severity of itching | 2 score on a scale | Standard Deviation 0 |
| PAI + ACB & IPACK | PAIN OUT Questionnaire at Post Operative Day (POD) 1 | Severity of dizziness | 6.1 score on a scale | Standard Deviation 3.75 |
| PAI + ACB & IPACK | PAIN OUT Questionnaire at Post Operative Day (POD) 1 | Were you allowed to participate in decisions about pain treatment? | 9.76 score on a scale | Standard Deviation 1.46 |
| PAI + ACB & IPACK | PAIN OUT Questionnaire at Post Operative Day (POD) 1 | Pain interfered or prevented you from activities in bed | 2.4 score on a scale | Standard Deviation 3.47 |
Secondary
PAIN OUT Questionnaire at Post Operative Day (POD) 14
The PAIN OUT questionnaire has multiple numeric scale questions on pain relief as well as pain intensity, along with Yes/No questions. There are also questions asking which pain relief techniques were used (multiple choice). All questions are scored on a scale of 0 to 10, with 0 meaning no pain/does not interfere/not at all and 10 meaning worst pain/completely interferes/extremely. A higher score means a worse outcome.
Time frame: at post operative day (POD) 14
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| No PAI + ACB & IPACK | PAIN OUT Questionnaire at Post Operative Day (POD) 14 | Least pain in 24 hours | 1.72 score on a scale | Standard Deviation 2.02 |
| No PAI + ACB & IPACK | PAIN OUT Questionnaire at Post Operative Day (POD) 14 | Worst pain in 24 hours | 5.6 score on a scale | Standard Deviation 2.62 |
| No PAI + ACB & IPACK | PAIN OUT Questionnaire at Post Operative Day (POD) 14 | Pain interfered or prevented you from activities in bed | 2.68 score on a scale | Standard Deviation 3.33 |
| No PAI + ACB & IPACK | PAIN OUT Questionnaire at Post Operative Day (POD) 14 | Pain interfered or prevented you from activities out of bed | 1.81 score on a scale | Standard Deviation 2.7 |
| No PAI + ACB & IPACK | PAIN OUT Questionnaire at Post Operative Day (POD) 14 | Pain interfered or prevented you from falling asleep | 3.02 score on a scale | Standard Deviation 3.92 |
| No PAI + ACB & IPACK | PAIN OUT Questionnaire at Post Operative Day (POD) 14 | Pain interfered or prevented you from staying asleep | 3.15 score on a scale | Standard Deviation 4.13 |
| No PAI + ACB & IPACK | PAIN OUT Questionnaire at Post Operative Day (POD) 14 | How much the pain caused you to feel anxious | .66 score on a scale | Standard Deviation 2.18 |
| No PAI + ACB & IPACK | PAIN OUT Questionnaire at Post Operative Day (POD) 14 | How much the pain caused you to feel depressed | .38 score on a scale | Standard Deviation 1.64 |
| No PAI + ACB & IPACK | PAIN OUT Questionnaire at Post Operative Day (POD) 14 | How much the pain caused you to feel frightened | .09 score on a scale | Standard Deviation 0.58 |
| No PAI + ACB & IPACK | PAIN OUT Questionnaire at Post Operative Day (POD) 14 | How much the pain caused you to feel helpless | .23 score on a scale | Standard Deviation 1.03 |
| No PAI + ACB & IPACK | PAIN OUT Questionnaire at Post Operative Day (POD) 14 | Severity of nausea | 5.5 score on a scale | Standard Deviation 2.08 |
| No PAI + ACB & IPACK | PAIN OUT Questionnaire at Post Operative Day (POD) 14 | Severity of drowsiness | 6 score on a scale | Standard Deviation 4.58 |
| No PAI + ACB & IPACK | PAIN OUT Questionnaire at Post Operative Day (POD) 14 | Severity of itching | 3.5 score on a scale | Standard Deviation 0.71 |
| No PAI + ACB & IPACK | PAIN OUT Questionnaire at Post Operative Day (POD) 14 | Severity of dizziness | 0 score on a scale | Standard Deviation 0 |
| No PAI + ACB & IPACK | PAIN OUT Questionnaire at Post Operative Day (POD) 14 | Were you allowed to participate in decisions about pain treatment? | 9.76 score on a scale | Standard Deviation 1.02 |
| No PAI + ACB & IPACK | PAIN OUT Questionnaire at Post Operative Day (POD) 14 | How satisfied are you with the results of your pain treatment? | 9.61 score on a scale | Standard Deviation 0.89 |
| PAI + ACB & IPACK | PAIN OUT Questionnaire at Post Operative Day (POD) 14 | How satisfied are you with the results of your pain treatment? | 9.71 score on a scale | Standard Deviation 1.5 |
| PAI + ACB & IPACK | PAIN OUT Questionnaire at Post Operative Day (POD) 14 | Least pain in 24 hours | 1.54 score on a scale | Standard Deviation 2.11 |
| PAI + ACB & IPACK | PAIN OUT Questionnaire at Post Operative Day (POD) 14 | How much the pain caused you to feel frightened | .07 score on a scale | Standard Deviation 0.44 |
| PAI + ACB & IPACK | PAIN OUT Questionnaire at Post Operative Day (POD) 14 | Worst pain in 24 hours | 5.26 score on a scale | Standard Deviation 2.72 |
| PAI + ACB & IPACK | PAIN OUT Questionnaire at Post Operative Day (POD) 14 | Severity of itching | 4.71 score on a scale | Standard Deviation 2.81 |
| PAI + ACB & IPACK | PAIN OUT Questionnaire at Post Operative Day (POD) 14 | Pain interfered or prevented you from activities in bed | 2.09 score on a scale | Standard Deviation 2.98 |
| PAI + ACB & IPACK | PAIN OUT Questionnaire at Post Operative Day (POD) 14 | How much the pain caused you to feel helpless | .07 score on a scale | Standard Deviation 0.44 |
| PAI + ACB & IPACK | PAIN OUT Questionnaire at Post Operative Day (POD) 14 | Pain interfered or prevented you from activities out of bed | 1.7 score on a scale | Standard Deviation 2.46 |
| PAI + ACB & IPACK | PAIN OUT Questionnaire at Post Operative Day (POD) 14 | Were you allowed to participate in decisions about pain treatment? | 10 score on a scale | Standard Deviation 0 |
| PAI + ACB & IPACK | PAIN OUT Questionnaire at Post Operative Day (POD) 14 | Pain interfered or prevented you from falling asleep | 2.85 score on a scale | Standard Deviation 3.88 |
| PAI + ACB & IPACK | PAIN OUT Questionnaire at Post Operative Day (POD) 14 | Severity of nausea | 0 score on a scale | Standard Deviation 0 |
| PAI + ACB & IPACK | PAIN OUT Questionnaire at Post Operative Day (POD) 14 | Pain interfered or prevented you from staying asleep | 3.26 score on a scale | Standard Deviation 3.96 |
| PAI + ACB & IPACK | PAIN OUT Questionnaire at Post Operative Day (POD) 14 | Severity of dizziness | 3 score on a scale | Standard Deviation 0 |
| PAI + ACB & IPACK | PAIN OUT Questionnaire at Post Operative Day (POD) 14 | How much the pain caused you to feel anxious | .54 score on a scale | Standard Deviation 1.86 |
| PAI + ACB & IPACK | PAIN OUT Questionnaire at Post Operative Day (POD) 14 | Severity of drowsiness | 4.4 score on a scale | Standard Deviation 1.52 |
| PAI + ACB & IPACK | PAIN OUT Questionnaire at Post Operative Day (POD) 14 | How much the pain caused you to feel depressed | .59 score on a scale | Standard Deviation 1.83 |
Secondary
PAIN OUT Questionnaire at Post Operative Day (POD) 14 / Percentage of Time in Severe Pain and Pain Relief
The PAIN OUT questionnaire has multiple numeric scale questions on pain relief as well as pain intensity, along with Yes/No questions. There are also questions asking which pain relief techniques were used (multiple choice). All questions are scored on a scale of 0 to 10, with 0 meaning no pain/does not interfere/not at all and 10 meaning worst pain/completely interferes/extremely. A higher score means a worse outcome. This outcome records the percentage of time in severe pain and percentage pain relief, both scored from 0% to 100%.
Time frame: at post operative day (POD) 14
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| No PAI + ACB & IPACK | PAIN OUT Questionnaire at Post Operative Day (POD) 14 / Percentage of Time in Severe Pain and Pain Relief | The percentage of time in severe pain on a scale of 0 - 10 | 14.47 percentage of time or relief | Standard Deviation 25.44 |
| No PAI + ACB & IPACK | PAIN OUT Questionnaire at Post Operative Day (POD) 14 / Percentage of Time in Severe Pain and Pain Relief | Pain relief in the first 24 hours on a scale of 0 - 10 | 9.65 percentage of time or relief | Standard Deviation 2.12 |
| PAI + ACB & IPACK | PAIN OUT Questionnaire at Post Operative Day (POD) 14 / Percentage of Time in Severe Pain and Pain Relief | The percentage of time in severe pain on a scale of 0 - 10 | 17.61 percentage of time or relief | Standard Deviation 28.3 |
| PAI + ACB & IPACK | PAIN OUT Questionnaire at Post Operative Day (POD) 14 / Percentage of Time in Severe Pain and Pain Relief | Pain relief in the first 24 hours on a scale of 0 - 10 | 9.5 percentage of time or relief | Standard Deviation 2.53 |
Secondary
PAIN OUT Questionnaire at Post Operative Day (POD) 1 / Percentage of Time in Severe Pain and Pain Relief
The PAIN OUT questionnaire has multiple numeric scale questions on pain relief as well as pain intensity, along with Yes/No questions. There are also questions asking which pain relief techniques were used (multiple choice). All questions are scored on a scale of 0 to 10, with 0 meaning no pain/does not interfere/not at all and 10 meaning worst pain/completely interferes/extremely. A higher score means a worse outcome. This outcome records the percentage of time in severe pain and percentage pain relief, both scored from 0% to 100%.
Time frame: at post operative day (POD) 1
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| No PAI + ACB & IPACK | PAIN OUT Questionnaire at Post Operative Day (POD) 1 / Percentage of Time in Severe Pain and Pain Relief | the percentage of time in severe pain | 12.55 percentage of time or relief | Standard Deviation 22.98 |
| No PAI + ACB & IPACK | PAIN OUT Questionnaire at Post Operative Day (POD) 1 / Percentage of Time in Severe Pain and Pain Relief | Pain relief in the first 24 hours | 9.93 percentage of time or relief | Standard Deviation 1.72 |
| PAI + ACB & IPACK | PAIN OUT Questionnaire at Post Operative Day (POD) 1 / Percentage of Time in Severe Pain and Pain Relief | the percentage of time in severe pain | 11.49 percentage of time or relief | Standard Deviation 20.74 |
| PAI + ACB & IPACK | PAIN OUT Questionnaire at Post Operative Day (POD) 1 / Percentage of Time in Severe Pain and Pain Relief | Pain relief in the first 24 hours | 10.14 percentage of time or relief | Standard Deviation 1.85 |
Secondary
PAIN OUT Questionnaire at Post Operative Day (POD) 90
The PAIN OUT questionnaire has multiple numeric scale questions on pain relief as well as pain intensity, along with Yes/No questions. There are also questions asking which pain relief techniques were used (multiple choice). All questions are scored on a scale of 0 to 10, with 0 meaning no pain/does not interfere/not at all and 10 meaning worst pain/completely interferes/extremely. A higher score means a worse outcome.
Time frame: at post operative day (POD) 90
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| No PAI + ACB & IPACK | PAIN OUT Questionnaire at Post Operative Day (POD) 90 | Least pain in 24 hours | .05 score on a scale | Standard Deviation 0.22 |
| No PAI + ACB & IPACK | PAIN OUT Questionnaire at Post Operative Day (POD) 90 | Worst pain in 24 hours | 1.68 score on a scale | Standard Deviation 2.18 |
| No PAI + ACB & IPACK | PAIN OUT Questionnaire at Post Operative Day (POD) 90 | Pain interfered or prevented you from activities in bed | .29 score on a scale | Standard Deviation 0.98 |
| No PAI + ACB & IPACK | PAIN OUT Questionnaire at Post Operative Day (POD) 90 | Pain interfered or prevented you from activities out of bed | .63 score on a scale | Standard Deviation 1.39 |
| No PAI + ACB & IPACK | PAIN OUT Questionnaire at Post Operative Day (POD) 90 | Pain interfered or prevented you from falling asleep | .61 score on a scale | Standard Deviation 1.96 |
| No PAI + ACB & IPACK | PAIN OUT Questionnaire at Post Operative Day (POD) 90 | Pain interfered or prevented you from staying asleep | .83 score on a scale | Standard Deviation 2.06 |
| No PAI + ACB & IPACK | PAIN OUT Questionnaire at Post Operative Day (POD) 90 | How much the pain caused you to feel anxious | .39 score on a scale | Standard Deviation 1.39 |
| No PAI + ACB & IPACK | PAIN OUT Questionnaire at Post Operative Day (POD) 90 | How much the pain caused you to feel depressed | .54 score on a scale | Standard Deviation 2.01 |
| No PAI + ACB & IPACK | PAIN OUT Questionnaire at Post Operative Day (POD) 90 | How much the pain caused you to feel frightened | 0 score on a scale | Standard Deviation 0 |
| No PAI + ACB & IPACK | PAIN OUT Questionnaire at Post Operative Day (POD) 90 | How much the pain caused you to feel helpless | 0 score on a scale | Standard Deviation 0 |
| No PAI + ACB & IPACK | PAIN OUT Questionnaire at Post Operative Day (POD) 90 | Severity of nausea | 0 score on a scale | Standard Deviation 0 |
| No PAI + ACB & IPACK | PAIN OUT Questionnaire at Post Operative Day (POD) 90 | Severity of drowsiness | 3 score on a scale | Standard Deviation 0 |
| No PAI + ACB & IPACK | PAIN OUT Questionnaire at Post Operative Day (POD) 90 | Severity of itching | 7 score on a scale | Standard Deviation 0 |
| No PAI + ACB & IPACK | PAIN OUT Questionnaire at Post Operative Day (POD) 90 | Severity of dizziness | 0 score on a scale | Standard Deviation 0 |
| No PAI + ACB & IPACK | PAIN OUT Questionnaire at Post Operative Day (POD) 90 | Were you allowed to participate in decisions about pain treatment? | 9.51 score on a scale | Standard Deviation 2.18 |
| No PAI + ACB & IPACK | PAIN OUT Questionnaire at Post Operative Day (POD) 90 | How satisfied are you with the results of your pain treatment? | 9.48 score on a scale | Standard Deviation 1.76 |
| PAI + ACB & IPACK | PAIN OUT Questionnaire at Post Operative Day (POD) 90 | How satisfied are you with the results of your pain treatment? | 9.81 score on a scale | Standard Deviation 0.87 |
| PAI + ACB & IPACK | PAIN OUT Questionnaire at Post Operative Day (POD) 90 | Least pain in 24 hours | .24 score on a scale | Standard Deviation 0.86 |
| PAI + ACB & IPACK | PAIN OUT Questionnaire at Post Operative Day (POD) 90 | How much the pain caused you to feel frightened | 0 score on a scale | Standard Deviation 0 |
| PAI + ACB & IPACK | PAIN OUT Questionnaire at Post Operative Day (POD) 90 | Worst pain in 24 hours | 1.81 score on a scale | Standard Deviation 2.15 |
| PAI + ACB & IPACK | PAIN OUT Questionnaire at Post Operative Day (POD) 90 | Severity of itching | 0 score on a scale | Standard Deviation 0 |
| PAI + ACB & IPACK | PAIN OUT Questionnaire at Post Operative Day (POD) 90 | Pain interfered or prevented you from activities in bed | .89 score on a scale | Standard Deviation 2.13 |
| PAI + ACB & IPACK | PAIN OUT Questionnaire at Post Operative Day (POD) 90 | How much the pain caused you to feel helpless | .14 score on a scale | Standard Deviation 0.82 |
| PAI + ACB & IPACK | PAIN OUT Questionnaire at Post Operative Day (POD) 90 | Pain interfered or prevented you from activities out of bed | .65 score on a scale | Standard Deviation 1.86 |
| PAI + ACB & IPACK | PAIN OUT Questionnaire at Post Operative Day (POD) 90 | Were you allowed to participate in decisions about pain treatment? | 10 score on a scale | Standard Deviation 0 |
| PAI + ACB & IPACK | PAIN OUT Questionnaire at Post Operative Day (POD) 90 | Pain interfered or prevented you from falling asleep | .43 score on a scale | Standard Deviation 1.48 |
| PAI + ACB & IPACK | PAIN OUT Questionnaire at Post Operative Day (POD) 90 | Severity of nausea | 0 score on a scale | Standard Deviation 0 |
| PAI + ACB & IPACK | PAIN OUT Questionnaire at Post Operative Day (POD) 90 | Pain interfered or prevented you from staying asleep | .86 score on a scale | Standard Deviation 2.18 |
| PAI + ACB & IPACK | PAIN OUT Questionnaire at Post Operative Day (POD) 90 | Severity of dizziness | 0 score on a scale | Standard Deviation 0 |
| PAI + ACB & IPACK | PAIN OUT Questionnaire at Post Operative Day (POD) 90 | How much the pain caused you to feel anxious | .35 score on a scale | Standard Deviation 1.23 |
| PAI + ACB & IPACK | PAIN OUT Questionnaire at Post Operative Day (POD) 90 | Severity of drowsiness | 0 score on a scale | Standard Deviation 0 |
| PAI + ACB & IPACK | PAIN OUT Questionnaire at Post Operative Day (POD) 90 | How much the pain caused you to feel depressed | .27 score on a scale | Standard Deviation 1.15 |
Secondary
PAIN OUT Questionnaire at Post Operative Day (POD) 90 / Percentage of Time in Severe Pain and Pain Relief
The PAIN OUT questionnaire has multiple numeric scale questions on pain relief as well as pain intensity, along with Yes/No questions. There are also questions asking which pain relief techniques were used (multiple choice). All questions are scored on a scale of 0 to 10, with 0 meaning no pain/does not interfere/not at all and 10 meaning worst pain/completely interferes/extremely. A higher score means a worse outcome. This outcome records the percentage of time in severe pain and percentage pain relief, both scored from 0% to 100%.
Time frame: at post operative day (POD) 90
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| No PAI + ACB & IPACK | PAIN OUT Questionnaire at Post Operative Day (POD) 90 / Percentage of Time in Severe Pain and Pain Relief | The percentage of time in severe pain | 9.02 percentage of time or relief | Standard Deviation 26.44 |
| No PAI + ACB & IPACK | PAIN OUT Questionnaire at Post Operative Day (POD) 90 / Percentage of Time in Severe Pain and Pain Relief | Pain relief in the first 24 hours | 10.12 percentage of time or relief | Standard Deviation 2.63 |
| PAI + ACB & IPACK | PAIN OUT Questionnaire at Post Operative Day (POD) 90 / Percentage of Time in Severe Pain and Pain Relief | The percentage of time in severe pain | 7.57 percentage of time or relief | Standard Deviation 23.5 |
| PAI + ACB & IPACK | PAIN OUT Questionnaire at Post Operative Day (POD) 90 / Percentage of Time in Severe Pain and Pain Relief | Pain relief in the first 24 hours | 10.37 percentage of time or relief | Standard Deviation 2.3 |
Secondary
PAIN OUT Questionnaire at Preoperation
The PAIN OUT questionnaire has multiple numeric scale questions on pain relief as well as pain intensity, along with Yes/No questions. There are also questions asking which pain relief techniques were used (multiple choice). All questions are scored on a scale of 0 to 10, with 0 meaning no pain/does not interfere/not at all and 10 meaning worst pain/completely interferes/extremely. A higher score means a worse outcome.
Time frame: at preoperation
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| No PAI + ACB & IPACK | PAIN OUT Questionnaire at Preoperation | Least pain in 24 hours | 0.96 score on a scale | Standard Deviation 1.96 |
| No PAI + ACB & IPACK | PAIN OUT Questionnaire at Preoperation | Worst pain in 24 hours | 6.57 score on a scale | Standard Deviation 2.83 |
| No PAI + ACB & IPACK | PAIN OUT Questionnaire at Preoperation | Pain interfered or prevented you from activities in bed | 3.11 score on a scale | Standard Deviation 3.51 |
| No PAI + ACB & IPACK | PAIN OUT Questionnaire at Preoperation | Pain interfered or prevented you from activities out of bed | 5.04 score on a scale | Standard Deviation 3.55 |
| No PAI + ACB & IPACK | PAIN OUT Questionnaire at Preoperation | Pain interfered or prevented you from falling asleep | 2.49 score on a scale | Standard Deviation 3.71 |
| No PAI + ACB & IPACK | PAIN OUT Questionnaire at Preoperation | Pain interfered or prevented you from staying asleep | 2.49 score on a scale | Standard Deviation 3.71 |
| No PAI + ACB & IPACK | PAIN OUT Questionnaire at Preoperation | How much the pain caused you to feel anxious | 1.02 score on a scale | Standard Deviation 2.55 |
| No PAI + ACB & IPACK | PAIN OUT Questionnaire at Preoperation | How much the pain caused you to feel depressed | 1.15 score on a scale | Standard Deviation 2.66 |
| No PAI + ACB & IPACK | PAIN OUT Questionnaire at Preoperation | How much the pain caused you to feel frightened | 0.49 score on a scale | Standard Deviation 1.72 |
| No PAI + ACB & IPACK | PAIN OUT Questionnaire at Preoperation | How much the pain caused you to feel helpless | 1.13 score on a scale | Standard Deviation 2.68 |
| No PAI + ACB & IPACK | PAIN OUT Questionnaire at Preoperation | Severity of nausea | 0 score on a scale | Standard Deviation 0 |
| No PAI + ACB & IPACK | PAIN OUT Questionnaire at Preoperation | Severity of drowsiness | 0 score on a scale | Standard Deviation 0 |
| No PAI + ACB & IPACK | PAIN OUT Questionnaire at Preoperation | Severity of itching | 0 score on a scale | Standard Deviation 0 |
| No PAI + ACB & IPACK | PAIN OUT Questionnaire at Preoperation | Severity of dizziness | 0 score on a scale | Standard Deviation 0 |
| No PAI + ACB & IPACK | PAIN OUT Questionnaire at Preoperation | Were you allowed to participate in decisions about pain treatment? | 7.5 score on a scale | Standard Deviation 5 |
| No PAI + ACB & IPACK | PAIN OUT Questionnaire at Preoperation | How satisfied are you with the results of your pain treatment? | 6.66 score on a scale | Standard Deviation 5.77 |
| PAI + ACB & IPACK | PAIN OUT Questionnaire at Preoperation | How satisfied are you with the results of your pain treatment? | 10 score on a scale | Standard Deviation 0 |
| PAI + ACB & IPACK | PAIN OUT Questionnaire at Preoperation | Least pain in 24 hours | 1.45 score on a scale | Standard Deviation 2.49 |
| PAI + ACB & IPACK | PAIN OUT Questionnaire at Preoperation | How much the pain caused you to feel frightened | 1.02 score on a scale | Standard Deviation 2.57 |
| PAI + ACB & IPACK | PAIN OUT Questionnaire at Preoperation | Worst pain in 24 hours | 6.79 score on a scale | Standard Deviation 2.7 |
| PAI + ACB & IPACK | PAIN OUT Questionnaire at Preoperation | Severity of itching | 0 score on a scale | Standard Deviation 0 |
| PAI + ACB & IPACK | PAIN OUT Questionnaire at Preoperation | Pain interfered or prevented you from activities in bed | 3.02 score on a scale | Standard Deviation 3.4 |
| PAI + ACB & IPACK | PAIN OUT Questionnaire at Preoperation | How much the pain caused you to feel helpless | 1.02 score on a scale | Standard Deviation 2.57 |
| PAI + ACB & IPACK | PAIN OUT Questionnaire at Preoperation | Pain interfered or prevented you from activities out of bed | 5.94 score on a scale | Standard Deviation 3.45 |
| PAI + ACB & IPACK | PAIN OUT Questionnaire at Preoperation | Were you allowed to participate in decisions about pain treatment? | 10 score on a scale | Standard Deviation 0 |
| PAI + ACB & IPACK | PAIN OUT Questionnaire at Preoperation | Pain interfered or prevented you from falling asleep | 3.06 score on a scale | Standard Deviation 4 |
| PAI + ACB & IPACK | PAIN OUT Questionnaire at Preoperation | Severity of nausea | 5 score on a scale | Standard Deviation 0 |
| PAI + ACB & IPACK | PAIN OUT Questionnaire at Preoperation | Pain interfered or prevented you from staying asleep | 3.06 score on a scale | Standard Deviation 4 |
| PAI + ACB & IPACK | PAIN OUT Questionnaire at Preoperation | Severity of dizziness | 0 score on a scale | Standard Deviation 0 |
| PAI + ACB & IPACK | PAIN OUT Questionnaire at Preoperation | How much the pain caused you to feel anxious | 1.89 score on a scale | Standard Deviation 3.23 |
| PAI + ACB & IPACK | PAIN OUT Questionnaire at Preoperation | Severity of drowsiness | 0 score on a scale | Standard Deviation 0 |
| PAI + ACB & IPACK | PAIN OUT Questionnaire at Preoperation | How much the pain caused you to feel depressed | 1.6 score on a scale | Standard Deviation 3.1 |
Secondary
PAIN OUT Questionnaire at Preoperation / Percentage of Time in Severe Pain and Pain Relief
The PAIN OUT questionnaire has multiple numeric scale questions on pain relief as well as pain intensity, along with Yes/No questions. There are also questions asking which pain relief techniques were used (multiple choice). All questions are scored on a scale of 0 to 10, with 0 meaning no pain/does not interfere/not at all and 10 meaning worst pain/completely interferes/extremely. A higher score means a worse outcome. This outcome records the percentage of time in severe pain and percentage pain relief, both scored from 0% to 100%.
Time frame: at preoperation
Population: preoperative
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| No PAI + ACB & IPACK | PAIN OUT Questionnaire at Preoperation / Percentage of Time in Severe Pain and Pain Relief | Percentage of time in severe pain | 17.02 percentage of time or relief | Standard Deviation 22.83 |
| No PAI + ACB & IPACK | PAIN OUT Questionnaire at Preoperation / Percentage of Time in Severe Pain and Pain Relief | Pain relief in the first 24 hours | 5.5 percentage of time or relief | Standard Deviation 3.07 |
| PAI + ACB & IPACK | PAIN OUT Questionnaire at Preoperation / Percentage of Time in Severe Pain and Pain Relief | Percentage of time in severe pain | 18.09 percentage of time or relief | Standard Deviation 27.4 |
| PAI + ACB & IPACK | PAIN OUT Questionnaire at Preoperation / Percentage of Time in Severe Pain and Pain Relief | Pain relief in the first 24 hours | 6.14 percentage of time or relief | Standard Deviation 2.91 |
Secondary
Quality of Recovery (POD1)
Quality of Recovery (QoR-9), This questionnaire has three options for scale (not at all, some of the time, most of the time). The QoR-9 is a nine-item scale. Total QoR-9-scores range from 0 to 18, with higher scores indicating good recovery after anaesthesia. The questions focus on the overall well being of the patient. The questionnaire will be asked 24 hours post surgical discharge.
Time frame: 24 hours post surgical discharge.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| No PAI + ACB & IPACK | Quality of Recovery (POD1) | 16.62 units on a scale | Standard Deviation 2.31 |
| PAI + ACB & IPACK | Quality of Recovery (POD1) | 16.96 units on a scale | Standard Deviation 2 |
Secondary
Satisfaction With Pain Management (POD1)
This questionnaire is a numeric scale from 0 (strongly dissatisfied) to 10 ( strongly satisfied). A higher number dictates a better outcome. This will be asked 24 hours post operative discharge.
Time frame: 24 hours post operative discharge.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| No PAI + ACB & IPACK | Satisfaction With Pain Management (POD1) | 9.7 score on a scale | Standard Deviation 0.81 |
| PAI + ACB & IPACK | Satisfaction With Pain Management (POD1) | 9.66 score on a scale | Standard Deviation 1.54 |
Secondary
Side Effects: Opioid-Related Symptom Distress Score (POD1)
The Opioid-related symptom distress scale evaluates frequency, severity, bothersomeness for 12 symptoms. Each symptom is scored on a 4-point scale, with 0 meaning better outcome and 4 meaning worst outcome. The questionnaire will be asked 24 hours (POD 1) post surgical discharge.
Time frame: 24 hours (POD 1) post surgical discharge.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| No PAI + ACB & IPACK | Side Effects: Opioid-Related Symptom Distress Score (POD1) | .55 score on a scale | Standard Deviation 0.97 |
| PAI + ACB & IPACK | Side Effects: Opioid-Related Symptom Distress Score (POD1) | .74 score on a scale | Standard Deviation 1.09 |