Pain, Postoperative
Conditions
Keywords
Pain, Postoperative
Brief summary
The purpose of this research study is to find out if taking Acetaminophen with Ibuprofen (e.g. Tylenol + Advil), a non-opioid regimen, provides the same type of pain relief after hand surgery compared to Acetaminophen and codeine (e.g. Tylenol 3), an opioid regimen.
Detailed description
Primary Objective: To establish, through a randomized control trial, whether post-operative Acetaminophen and Ibuprofen (non-opioid regimen) would provide equivalent post-operative analgesia to ambulatory hand surgery patients compared to Acetaminophen and Codeine (opioid regimen). Secondary Objective: To establish whether the opioid versus non-opioid post-operative pain regimen influences patient satisfaction. Sixty-three patients enrolled for each group (non-opioid and opioid). Approximately 145 patients will be required to achieve complete data for 63 patients in each group (assuming 15% lost to follow-up & failure to comply with study protocol).
Interventions
After hand surgery, take Acetaminophen 650 mg/Ibuprofen 400 mg every 6 hours as needed for pain until postoperative clinic visit
DRUGAcetaminophen/Codeine
After hand surgery, take Acetaminophen 300mg/Codeine 30 mg every 6 hours as needed for pain until postoperative clinic visit
Sponsors
University of Pennsylvania
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients undergoing ambulatory hand surgery for carpal tunnel and trigger finger, under local anesthesia with or without sedation.
Exclusion criteria
* ASA\> 3; * Coagulopathy; * Renal disease, * Liver disease, * History of recent gastro-intestinal bleeding * Pregnancy. * Diagnosis of chronic pain currently taking opioid pain medication or with a history of drug abuse. * Patients with a self-described allergy to ASA, acetaminophen, NSAIDS and codeine. * All patients receiving a brachial plexus block for anesthesia and/or analgesia
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assessing Change in Pain Using the Visual Analogue Scale (VAS) Pain Score | Subjects reported pain 3 times a day each day after hand surgery (at dinner time, before going to sleep and in the middle of the night), until post-op appointment (between 4 and 8 days after surgery). The numbers reported are the average daily pain scores | To establish, through a randomized control trial, whether post-operative Acetaminophen and Ibuprofen (non-opioid regimen) would provide equivalent post-operative analgesia to ambulatory hand surgery patients compared to Acetaminophen and Codeine (opioid regimen). The pain VAS is a continuous scale where 0=no pain and 10=worst pain imaginable. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Recovery-9 (QoR-9). | Postoperative Day 2 | To establish whether the opioid versus non-opioid post-operative pain regimen influences patient satisfaction through Quality of Recovery (QoR) scores in ambulatory hand surgery. This 9 question survey has a maximum score (best outcome) of 18 and minimum (worst outcome) of 3. The survey was administered over the phone on post-operative day 2. |
| Number of Pills Used | From the time of surgery to first clinic visit (post-op day 6 to 8) | — |
Countries
United States
Participant flow
Recruitment details
All patients were recruited between 11/18/15 and 1/10/18 and were identified on the physicians surgery schedule as patients receiving either trigger finger or carpel tunnel surgery.
Pre-assignment details
There were 4 patients that were enrolled but did not make it to the randomization stage. 2 patients had liver disease and therefore met exclusion criteria for the study. The other 2 patients did not have surgery.
Participants by arm
| Arm | Count |
|---|---|
| Acetaminophen/Ibuprofen Group 1: Acetaminophen 650 mg; Ibuprofen 400 mg
Acetaminophen/Ibuprofen: After surgery, take Acetaminophen 650 mg/Ibuprofen 400 mg every 6 hours as needed for pain until postoperative clinic visit | 54 |
| Acetaminophen/Codeine Group 2: Acetaminophen 300mg, Codeine 30 mg
Acetaminophen/Codeine: After surgery, take Acetaminophen 300mg/Codeine 30 mg every 6 hours as needed for pain until postoperative clinic visit | 57 |
| Total | 111 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Did not want opiate | 0 | 1 |
| Overall Study | Felt itchy with assigned medication | 1 | 0 |
| Overall Study | Felt nauseous with assigned medication | 1 | 1 |
| Overall Study | Lost to Follow-up | 13 | 11 |
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Acetaminophen/Ibuprofen | Total | Acetaminophen/Codeine |
|---|---|---|---|
| Age, Continuous | 60 years STANDARD_DEVIATION 12 | 59 years STANDARD_DEVIATION 12 | 59 years STANDARD_DEVIATION 13 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 4 Participants | 5 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 17 Participants | 36 Participants | 19 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 | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) White | 32 Participants | 68 Participants | 36 Participants |
| Sex: Female, Male Female | 37 Participants | 75 Participants | 38 Participants |
| Sex: Female, Male Male | 17 Participants | 36 Participants | 19 Participants |
| VAS Pain Score | 1.93 units on a scale STANDARD_DEVIATION 2.04 | 2.22 units on a scale STANDARD_DEVIATION 2.3 | 2.50 units on a scale STANDARD_DEVIATION 2.51 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 70 | 0 / 70 |
| other Total, other adverse events | 32 / 70 | 30 / 70 |
| serious Total, serious adverse events | 0 / 70 | 0 / 70 |
Outcome results
Primary
Assessing Change in Pain Using the Visual Analogue Scale (VAS) Pain Score
To establish, through a randomized control trial, whether post-operative Acetaminophen and Ibuprofen (non-opioid regimen) would provide equivalent post-operative analgesia to ambulatory hand surgery patients compared to Acetaminophen and Codeine (opioid regimen). The pain VAS is a continuous scale where 0=no pain and 10=worst pain imaginable.
Time frame: Subjects reported pain 3 times a day each day after hand surgery (at dinner time, before going to sleep and in the middle of the night), until post-op appointment (between 4 and 8 days after surgery). The numbers reported are the average daily pain scores
Population: 111 patients completed the study and their data was included in the analysis
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Acetaminophen/Ibuprofen | Assessing Change in Pain Using the Visual Analogue Scale (VAS) Pain Score | VAS Pain Day 3 | 1.69 score on a scale | Standard Deviation 2 |
| Acetaminophen/Ibuprofen | Assessing Change in Pain Using the Visual Analogue Scale (VAS) Pain Score | VAS Pain Day 5 | 1.23 score on a scale | Standard Deviation 1.61 |
| Acetaminophen/Ibuprofen | Assessing Change in Pain Using the Visual Analogue Scale (VAS) Pain Score | VAS Pain Day 2 | 2.36 score on a scale | Standard Deviation 2.31 |
| Acetaminophen/Ibuprofen | Assessing Change in Pain Using the Visual Analogue Scale (VAS) Pain Score | VAS Pain Day 6 | 1.29 score on a scale | Standard Deviation 1.49 |
| Acetaminophen/Ibuprofen | Assessing Change in Pain Using the Visual Analogue Scale (VAS) Pain Score | VAS Pain Day 4 | 1.47 score on a scale | Standard Deviation 1.82 |
| Acetaminophen/Ibuprofen | Assessing Change in Pain Using the Visual Analogue Scale (VAS) Pain Score | VAS Pain Day 7 | 1.17 score on a scale | Standard Deviation 1.38 |
| Acetaminophen/Ibuprofen | Assessing Change in Pain Using the Visual Analogue Scale (VAS) Pain Score | VAS Pain Day 1 | 2.90 score on a scale | Standard Deviation 2.22 |
| Acetaminophen/Codeine | Assessing Change in Pain Using the Visual Analogue Scale (VAS) Pain Score | VAS Pain Day 7 | 1.01 score on a scale | Standard Deviation 1.21 |
| Acetaminophen/Codeine | Assessing Change in Pain Using the Visual Analogue Scale (VAS) Pain Score | VAS Pain Day 1 | 3.51 score on a scale | Standard Deviation 2.69 |
| Acetaminophen/Codeine | Assessing Change in Pain Using the Visual Analogue Scale (VAS) Pain Score | VAS Pain Day 2 | 2.40 score on a scale | Standard Deviation 2.52 |
| Acetaminophen/Codeine | Assessing Change in Pain Using the Visual Analogue Scale (VAS) Pain Score | VAS Pain Day 3 | 2.26 score on a scale | Standard Deviation 2.38 |
| Acetaminophen/Codeine | Assessing Change in Pain Using the Visual Analogue Scale (VAS) Pain Score | VAS Pain Day 4 | 1.93 score on a scale | Standard Deviation 2.01 |
| Acetaminophen/Codeine | Assessing Change in Pain Using the Visual Analogue Scale (VAS) Pain Score | VAS Pain Day 5 | 1.48 score on a scale | Standard Deviation 1.48 |
| Acetaminophen/Codeine | Assessing Change in Pain Using the Visual Analogue Scale (VAS) Pain Score | VAS Pain Day 6 | 1.35 score on a scale | Standard Deviation 1.37 |
Secondary
Number of Pills Used
Time frame: From the time of surgery to first clinic visit (post-op day 6 to 8)
Population: Of the 111 subjects that completed the study, data about how many capsules were used was available for 100 participants.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Acetaminophen/Ibuprofen | Number of Pills Used | 13.72 Pills | Standard Deviation 8.04 |
| Acetaminophen/Codeine | Number of Pills Used | 14.14 Pills | Standard Deviation 9.77 |
Secondary
Quality of Recovery-9 (QoR-9).
To establish whether the opioid versus non-opioid post-operative pain regimen influences patient satisfaction through Quality of Recovery (QoR) scores in ambulatory hand surgery. This 9 question survey has a maximum score (best outcome) of 18 and minimum (worst outcome) of 3. The survey was administered over the phone on post-operative day 2.
Time frame: Postoperative Day 2
Population: Of the 111 subjects that completed the study, QoR score was available for 93 participants.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Acetaminophen/Ibuprofen | Quality of Recovery-9 (QoR-9). | 16.91 Scores on a scale | Standard Deviation 1.38 |
| Acetaminophen/Codeine | Quality of Recovery-9 (QoR-9). | 16.65 Scores on a scale | Standard Deviation 1.91 |