A Phase 4 interventional study of Periarticular Injection (PAI) and Saline Control Periarticular Injection (PAI) in Total Knee Athroplasty, sponsored by Hospital for Special Surgery, New York. Completed at 1 site in United States. Open to participants aged 25 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-12-27.
Sponsored by Hospital for Special Surgery, New York · Phase 4, Interventional, and Supportive care
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:
Participants will be assigned to one of the following groups at random:
Participants will also be asked to complete pre- and post-operative questionnaires.
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.
Hospital for Special Surgery, New York is the lead sponsor of 226 studies on the registry; 40 are open to participants now.
Of its 30 completed or terminated interventional studies of FDA-regulated products, 22 (73%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Control: saline injection (same injection technique and volumes as described for the active intervention, of normal saline)
Drug: Saline Control Periarticular Injection (PAI)
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
Drug: Periarticular Injection (PAI)
PAI is a widely-utilized, surgeon-performed, analgesic intervention for TKA patients.
equal volume of saline will be used in place of analgesics used in PAI injections
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
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.
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
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
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
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.
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.
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.
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
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.
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
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
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
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
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
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
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
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
| Milestone | No PAI + ACB & IPACK | PAI + ACB & IPACK |
|---|---|---|
| Started | 47 | 47 |
| Completed | 41 | 37 |
| Not completed | 6 | 10 |
| Withdrew: Lost to follow-up | 6 | 10 |
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.
| units on a scale | No PAI + ACB & IPACK | PAI + ACB & IPACK |
|---|---|---|
| Pain Scores (NRS, 0-10) With Ambulation on POD1 | 4.55 ± 2.7 | 4.26 ± 3.03 |
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.
| MME/day | No PAI + ACB & IPACK | PAI + ACB & IPACK |
|---|---|---|
| post anesthesia care unit (PACU) | 25.45 ± 13.71 | 21.98 ± 12.02 |
| post operative day (POD) 1 | 25.95 ± 20.04 | 22.16 ± 21.17 |
| post operative day (POD) 2 | 37.3 ± 24.86 | 28.64 ± 30.21 |
| post operative day (POD) 14 | 6.91 ± 10.53 | 6.68 ± 10.4 |
| post operative day (POD) 90 | 0.27 ± 1.3 | 0.2 ± 1.23 |
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.
| units on a scale | No PAI + ACB & IPACK | PAI + ACB & IPACK |
|---|---|---|
| Pre-operation | 5.17 ± 2.52 | 5.85 ± 2.62 |
| Post anesthesia care unit (PACU) | 5.7 ± 3.11 | 5.19 ± 2.92 |
| Post operative day (POD) 1 | 4.55 ± 2.7 | 4.26 ± 3.03 |
| Post operative day (POD) 2 | 6.68 ± 2.29 | 6.13 ± 2.62 |
| Post operative day (POD) 3 months | 1.02 ± 1.82 | 0.95 ± 1.47 |
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
| units on a scale | No PAI + ACB & IPACK | PAI + ACB & IPACK |
|---|---|---|
| pre-operation | 1.19 ± 2.05 | 1.79 ± 2.8 |
| post anesthesia care unit (PACU) | 5.66 ± 3.17 | 5.06 ± 2.91 |
| post operative day (POD) 1 | 2.36 ± 2.29 | 2.47 ± 2.86 |
| post operative day (POD) 2 | 4.09 ± 2.95 | 4.13 ± 3.06 |
| post operative day (POD) 3 months | 0.29 ± 0.93 | 0.46 ± 1.02 |
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.
| score on a scale | No PAI + ACB & IPACK | PAI + ACB & IPACK |
|---|---|---|
| Least pain in 24 hours | 0.96 ± 1.96 | 1.45 ± 2.49 |
| Worst pain in 24 hours | 6.57 ± 2.83 | 6.79 ± 2.7 |
| Pain interfered or prevented you from activities in bed | 3.11 ± 3.51 | 3.02 ± 3.4 |
| Pain interfered or prevented you from activities out of bed | 5.04 ± 3.55 | 5.94 ± 3.45 |
| Pain interfered or prevented you from falling asleep | 2.49 ± 3.71 | 3.06 ± 4 |
| Pain interfered or prevented you from staying asleep | 2.49 ± 3.71 | 3.06 ± 4 |
| How much the pain caused you to feel anxious | 1.02 ± 2.55 | 1.89 ± 3.23 |
| How much the pain caused you to feel depressed | 1.15 ± 2.66 | 1.6 ± 3.1 |
| How much the pain caused you to feel frightened | 0.49 ± 1.72 | 1.02 ± 2.57 |
| How much the pain caused you to feel helpless | 1.13 ± 2.68 | 1.02 ± 2.57 |
| Severity of nausea | 0 ± 0 | 5 ± 0 |
| Severity of drowsiness | 0 ± 0 | 0 ± 0 |
| Severity of itching | 0 ± 0 | 0 ± 0 |
| Severity of dizziness | 0 ± 0 | 0 ± 0 |
| Were you allowed to participate in decisions about pain treatment? | 7.5 ± 5 | 10 ± 0 |
| How satisfied are you with the results of your pain treatment? | 6.66 ± 5.77 | 10 ± 0 |
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.
| units on a scale | No PAI + ACB & IPACK | PAI + ACB & IPACK |
|---|---|---|
| Quality of Recovery (POD1) | 16.62 ± 2.31 | 16.96 ± 2 |
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.
| score on a scale | No PAI + ACB & IPACK | PAI + ACB & IPACK |
|---|---|---|
| Side Effects: Opioid-Related Symptom Distress Score (POD1) | .55 ± .97 | .74 ± 1.09 |
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.
| score on a scale | No PAI + ACB & IPACK | PAI + ACB & IPACK |
|---|---|---|
| Satisfaction With Pain Management (POD1) | 9.7 ± .81 | 9.66 ± 1.54 |
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.
| Participants | No PAI + ACB & IPACK | PAI + ACB & IPACK |
|---|---|---|
| Subjects Guess — Guessed that the subject was in the "No PAI+ACB & IPACK" group | 10 | 8 |
| Subjects Guess — Guessed that the subject was in the "PAI+ACB & IPACK" group | 13 | 17 |
| Subjects Guess — Guessed "Don't know" | 24 | 22 |
| Research Assistant Guess — Guessed that the subject was in the "No PAI+ACB & IPACK" group | 0 | 3 |
| Research Assistant Guess — Guessed that the subject was in the "PAI+ACB & IPACK" group | 4 | 7 |
| Research Assistant Guess — Guessed "Don't know" | 43 | 37 |
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.
| score on a scale | No PAI + ACB & IPACK | PAI + ACB & IPACK |
|---|---|---|
| at peroperation | 2.79 ± 1.35 | 2.62 ± 1.11 |
| post operative day (POD) 3 months | 2.63 ± .92 | 2.78 ± .92 |
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.
| score on a scale | No PAI + ACB & IPACK | PAI + ACB & IPACK |
|---|---|---|
| at preoperation | 50.7 ± 16.2 | 49.61 ± 16.57 |
| at 6 weeks | 78.31 ± 11.36 | 77.05 ± 12.86 |
| at 3 months | 83.39 ± 13.83 | 83.60 ± 9.57 |
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.
| score on a scale | No PAI + ACB & IPACK | PAI + ACB & IPACK |
|---|---|---|
| Least pain in 24 hours | 1.17 ± 2.05 | 1.34 ± 2.55 |
| Worst pain in 24 hours | 6.53 ± 2.69 | 6.15 ± 2.97 |
| Pain interfered or prevented you from activities in bed | 2.32 ± 3.85 | 2.4 ± 3.47 |
| Pain interfered or prevented you from activities out of bed | 3.13 ± 3.85 | 2.4 ± 3.47 |
| Pain interfered or prevented you from falling asleep | 1.06 ± 2.63 | .85 ± 2.29 |
| Pain interfered or prevented you from staying asleep | 1.19 ± 2.84 | .96 ± 2.64 |
| How much the pain caused you to feel anxious | .66 ± 2.1 | .23 ± .94 |
| How much the pain caused you to feel depressed | 0 ± 0 | .11 ± .73 |
| How much the pain caused you to feel frightened | .32 ± 1.62 | .26 ± 1.37 |
| How much the pain caused you to feel helpless | .32 ± 1.62 | 0 ± 0 |
| Severity of nausea | 6 ± 3.59 | 8.57 ± 2.9 |
| Severity of drowsiness | 6.64 ± 2.69 | 6.72 ± 2.91 |
| Severity of itching | 0 ± 0 | 2 ± 0 |
| Severity of dizziness | 4.86 ± 3.23 | 6.1 ± 3.75 |
| Were you allowed to participate in decisions about pain treatment? | 10 ± 0 | 9.76 ± 1.46 |
| How satisfied are you with the results of your pain treatment? | 9.78 ± .68 | 9.68 ± 1.53 |
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.
| score on a scale | No PAI + ACB & IPACK | PAI + ACB & IPACK |
|---|---|---|
| Least pain in 24 hours | 1.72 ± 2.02 | 1.54 ± 2.11 |
| Worst pain in 24 hours | 5.6 ± 2.62 | 5.26 ± 2.72 |
| Pain interfered or prevented you from activities in bed | 2.68 ± 3.33 | 2.09 ± 2.98 |
| Pain interfered or prevented you from activities out of bed | 1.81 ± 2.7 | 1.7 ± 2.46 |
| Pain interfered or prevented you from falling asleep | 3.02 ± 3.92 | 2.85 ± 3.88 |
| Pain interfered or prevented you from staying asleep | 3.15 ± 4.13 | 3.26 ± 3.96 |
| How much the pain caused you to feel anxious | .66 ± 2.18 | .54 ± 1.86 |
| How much the pain caused you to feel depressed | .38 ± 1.64 | .59 ± 1.83 |
| How much the pain caused you to feel frightened | .09 ± .58 | .07 ± .44 |
| How much the pain caused you to feel helpless | .23 ± 1.03 | .07 ± .44 |
| Severity of nausea | 5.5 ± 2.08 | 0 ± 0 |
| Severity of drowsiness | 6 ± 4.58 | 4.4 ± 1.52 |
| Severity of itching | 3.5 ± .71 | 4.71 ± 2.81 |
| Severity of dizziness | 0 ± 0 | 3 ± 0 |
| Were you allowed to participate in decisions about pain treatment? | 9.76 ± 1.02 | 10 ± 0 |
| How satisfied are you with the results of your pain treatment? | 9.61 ± .89 | 9.71 ± 1.5 |
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.
| score on a scale | No PAI + ACB & IPACK | PAI + ACB & IPACK |
|---|---|---|
| Least pain in 24 hours | .05 ± .22 | .24 ± .86 |
| Worst pain in 24 hours | 1.68 ± 2.18 | 1.81 ± 2.15 |
| Pain interfered or prevented you from activities in bed | .29 ± .98 | .89 ± 2.13 |
| Pain interfered or prevented you from activities out of bed | .63 ± 1.39 | .65 ± 1.86 |
| Pain interfered or prevented you from falling asleep | .61 ± 1.96 | .43 ± 1.48 |
| Pain interfered or prevented you from staying asleep | .83 ± 2.06 | .86 ± 2.18 |
| How much the pain caused you to feel anxious | .39 ± 1.39 | .35 ± 1.23 |
| How much the pain caused you to feel depressed | .54 ± 2.01 | .27 ± 1.15 |
| How much the pain caused you to feel frightened | 0 ± 0 | 0 ± 0 |
| How much the pain caused you to feel helpless | 0 ± 0 | .14 ± .82 |
| Severity of nausea | 0 ± 0 | 0 ± 0 |
| Severity of drowsiness | 3 ± 0 | 0 ± 0 |
| Severity of itching | 7 ± 0 | 0 ± 0 |
| Severity of dizziness | 0 ± 0 | 0 ± 0 |
| Were you allowed to participate in decisions about pain treatment? | 9.51 ± 2.18 | 10 ± 0 |
| How satisfied are you with the results of your pain treatment? | 9.48 ± 1.76 | 9.81 ± .87 |
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%.
| percentage of time or relief | No PAI + ACB & IPACK | PAI + ACB & IPACK |
|---|---|---|
| Percentage of time in severe pain | 17.02 ± 22.83 | 18.09 ± 27.4 |
| Pain relief in the first 24 hours | 5.5 ± 3.07 | 6.14 ± 2.91 |
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%.
| percentage of time or relief | No PAI + ACB & IPACK | PAI + ACB & IPACK |
|---|---|---|
| the percentage of time in severe pain | 12.55 ± 22.98 | 11.49 ± 20.74 |
| Pain relief in the first 24 hours | 9.93 ± 1.72 | 10.14 ± 1.85 |
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%.
| percentage of time or relief | No PAI + ACB & IPACK | PAI + ACB & IPACK |
|---|---|---|
| The percentage of time in severe pain on a scale of 0 - 10 | 14.47 ± 25.44 | 17.61 ± 28.3 |
| Pain relief in the first 24 hours on a scale of 0 - 10 | 9.65 ± 2.12 | 9.5 ± 2.53 |
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%.
| percentage of time or relief | No PAI + ACB & IPACK | PAI + ACB & IPACK |
|---|---|---|
| The percentage of time in severe pain | 9.02 ± 26.44 | 7.57 ± 23.5 |
| Pain relief in the first 24 hours | 10.12 ± 2.63 | 10.37 ± 2.30 |
Collected over Adverse event data were collected from subject enrollment through completion of data collection (3 months after surgery).. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| No PAI + ACB & IPACK | 0/47 (0%) | 1/47 (2.1%) | 0/47 (0%) |
| PAI + ACB & IPACK | 0/47 (0%) | 2/47 (4.3%) | 0/47 (0%) |
| Event | No PAI + ACB & IPACK | PAI + ACB & IPACK |
|---|---|---|
| leakage at the incision siteSurgical and medical procedures | 0/47 | 1/47 |
| postoperative myocardial infarctionCardiac disorders | 1/47 | 0/47 |
| postoperative reduced range of motionSurgical and medical procedures | 0/47 | 1/47 |
| Age, Continuous(years) | No PAI + ACB & IPACK | PAI + ACB & IPACK | Total |
|---|---|---|---|
| Mean | 67 ± 6 | 66 ± 7 | 66 ± 6 |
| Sex: Female, Male(Participants) | No PAI + ACB & IPACK | PAI + ACB & IPACK | Total |
|---|---|---|---|
| Female | 21 | 22 | 43 |
| Male | 26 | 25 | 51 |
| Ethnicity (NIH/OMB)(Participants) | No PAI + ACB & IPACK | PAI + ACB & IPACK | Total |
|---|---|---|---|
| Hispanic or Latino | 3 | 8 | 11 |
| Not Hispanic or Latino | 44 | 39 | 83 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | No PAI + ACB & IPACK | PAI + ACB & IPACK | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 1 | 0 | 1 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 6 | 4 | 10 |
| White | 39 | 42 | 81 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 1 | 1 | 2 |
| Body Mass Index(kg/m^2) | No PAI + ACB & IPACK | PAI + ACB & IPACK | Total |
|---|---|---|---|
| Mean | 30 ± 3 | 31 ± 4 | 30 ± 4 |
| American Society of Anesthesiologists Status(Participants) | No PAI + ACB & IPACK | PAI + ACB & IPACK | Total |
|---|---|---|---|
| ASA 1 | 5 | 1 | 6 |
| ASA 2 | 39 | 46 | 85 |
| ASA 3 | 3 | 0 | 3 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — Individual participant data that underlie the results reported in this article after de-identification (text, tables, figures, and appendices).
Supporting information: Study protocol
Time frame: Beginning 9 months and ending 36 months following article publication.
Access criteria: Investigators whose proposed use of the data has been approved by an Independent review committee ("learned intermediary") identified for this purpose and who have signed a DUA.
Ran from Dec 2020 to primary completion in Apr 2022, 15 months.
Results were first posted in Jun 2024, 2 years 2 months after primary completion.
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This study is completed, as verified in May 2024. You cannot join it, but the record below documents what was studied.
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