Acetaminophen/Codeine vs Acetaminophen/Ibuprofen for Pain Control and Patient Satisfaction After Hand Surgery
Sponsor
University of Pennsylvania (Other)
Overall Status
Completed
CT.gov ID
NCT02647788
Collaborator
(none)
144
1
2
25.6
5.6
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 4 |
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).
Study Design
Study Type:
Interventional
Actual Enrollment
:
144 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
Pilot Study, Blinded Randomized Control Trial, Single Center Study to Compare Acetaminophen & Codeine Versus Ibuprofen/Acetaminophen for Pain Control and Patient Satisfaction After Ambulatory Hand Surgery
Study Start Date
:
Dec 1, 2015
Actual Primary Completion Date
:
Jan 19, 2018
Actual Study Completion Date
:
Jan 19, 2018
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Acetaminophen/Ibuprofen Group 1: Acetaminophen 650 mg; Ibuprofen 400 mg |
Drug: Acetaminophen/Ibuprofen
After hand surgery, take Acetaminophen 650 mg/Ibuprofen 400 mg every 6 hours as needed for pain until postoperative clinic visit
Other Names:
|
| Active Comparator: Acetaminophen/Codeine Group 2: Acetaminophen 300mg, Codeine 30 mg |
Drug: Acetaminophen/Codeine
After hand surgery, take Acetaminophen 300mg/Codeine 30 mg every 6 hours as needed for pain until postoperative clinic visit
Other Names:
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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)]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts 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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Pennsylvania Health System | Philadelphia | Pennsylvania | United States | 19104 |
Sponsors and Collaborators
- University of Pennsylvania
Investigators
- Principal Investigator: David Steinberg, MD, University of Pennsylvania
Study Documents (Full-Text)
More Information
Publications
None provided.Responsible Party:
University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT02647788
Other Study ID Numbers:
- BACH-2015, 823043
First Posted:
Jan 6, 2016
Last Update Posted:
Feb 18, 2019
Last Verified:
Feb 1, 2019
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Keywords provided by University of Pennsylvania
Additional relevant MeSH terms:
Study Results
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 Detail | 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. |
| Arm/Group Title | Acetaminophen/Ibuprofen | Acetaminophen/Codeine |
|---|---|---|
| Arm/Group Description | Group 1: Acetaminophen 650 mg; Ibuprofen 400 mg Acetaminophen/Ibuprofen: After hand surgery, take Acetaminophen 650 mg/Ibuprofen 400 mg every 6 hours as needed for pain until postoperative clinic visit | Group 2: Acetaminophen 300mg, Codeine 30 mg Acetaminophen/Codeine: After hand surgery, take Acetaminophen 300mg/Codeine 30 mg every 6 hours as needed for pain until postoperative clinic visit |
| Period Title: Overall Study | ||
| STARTED | 70 | 70 |
| COMPLETED | 54 | 57 |
| NOT COMPLETED | 16 | 13 |
Baseline Characteristics
| Arm/Group Title | Acetaminophen/Ibuprofen | Acetaminophen/Codeine | Total |
|---|---|---|---|
| Arm/Group Description | 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 | 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 | Total of all reporting groups |
| Overall Participants | 54 | 57 | 111 |
| Age (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
60
(12)
|
59
(13)
|
59
(12)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
37
68.5%
|
38
66.7%
|
75
67.6%
|
| Male |
17
31.5%
|
19
33.3%
|
36
32.4%
|
| Race (NIH/OMB) (Count of Participants) | |||
| American Indian or Alaska Native |
0
0%
|
0
0%
|
0
0%
|
| Asian |
4
7.4%
|
1
1.8%
|
5
4.5%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
| Black or African American |
17
31.5%
|
19
33.3%
|
36
32.4%
|
| White |
32
59.3%
|
36
63.2%
|
68
61.3%
|
| More than one race |
0
0%
|
0
0%
|
0
0%
|
| Unknown or Not Reported |
1
1.9%
|
1
1.8%
|
2
1.8%
|
| VAS Pain Score (units on a scale) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [units on a scale] |
1.93
(2.04)
|
2.50
(2.51)
|
2.22
(2.30)
|
Outcome Measures
| Title | Assessing Change in Pain Using the Visual Analogue Scale (VAS) Pain Score |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 111 patients completed the study and their data was included in the analysis |
| Arm/Group Title | Acetaminophen/Ibuprofen | Acetaminophen/Codeine |
|---|---|---|
| Arm/Group Description | Group 1: Acetaminophen 650 mg; Ibuprofen 400 mg Acetaminophen/Ibuprofen: After hand surgery, take Acetaminophen 650 mg/Ibuprofen 400 mg every 6 hours as needed for pain until postoperative clinic visit | Group 2: Acetaminophen 300mg, Codeine 30 mg Acetaminophen/Codeine: After hand surgery, take Acetaminophen 300mg/Codeine 30 mg every 6 hours as needed for pain until postoperative clinic visit |
| Measure Participants | 54 | 57 |
| VAS Pain Day 1 |
2.90
(2.22)
|
3.51
(2.69)
|
| VAS Pain Day 2 |
2.36
(2.31)
|
2.40
(2.52)
|
| VAS Pain Day 3 |
1.69
(2.00)
|
2.26
(2.38)
|
| VAS Pain Day 4 |
1.47
(1.82)
|
1.93
(2.01)
|
| VAS Pain Day 5 |
1.23
(1.61)
|
1.48
(1.48)
|
| VAS Pain Day 6 |
1.29
(1.49)
|
1.35
(1.37)
|
| VAS Pain Day 7 |
1.17
(1.38)
|
1.01
(1.21)
|
| Title | Quality of Recovery-9 (QoR-9). |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Of the 111 subjects that completed the study, QoR score was available for 93 participants. |
| Arm/Group Title | Acetaminophen/Ibuprofen | Acetaminophen/Codeine |
|---|---|---|
| Arm/Group Description | Group 1: Acetaminophen 650 mg; Ibuprofen 400 mg Acetaminophen/Ibuprofen: After hand surgery, take Acetaminophen 650 mg/Ibuprofen 400 mg every 6 hours as needed for pain until postoperative clinic visit | Group 2: Acetaminophen 300mg, Codeine 30 mg Acetaminophen/Codeine: After hand surgery, take Acetaminophen 300mg/Codeine 30 mg every 6 hours as needed for pain until postoperative clinic visit |
| Measure Participants | 44 | 49 |
| Mean (Standard Deviation) [Scores on a scale] |
16.91
(1.38)
|
16.65
(1.91)
|
| Title | Number of Pills Used |
|---|---|
| Description | |
| Time Frame | From the time of surgery to first clinic visit (post-op day 6 to 8) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Of the 111 subjects that completed the study, data about how many capsules were used was available for 100 participants. |
| Arm/Group Title | Acetaminophen/Ibuprofen | Acetaminophen/Codeine |
|---|---|---|
| Arm/Group Description | Group 1: Acetaminophen 650 mg; Ibuprofen 400 mg Acetaminophen/Ibuprofen: After hand surgery, take Acetaminophen 650 mg/Ibuprofen 400 mg every 6 hours as needed for pain until postoperative clinic visit | Group 2: Acetaminophen 300mg, Codeine 30 mg Acetaminophen/Codeine: After hand surgery, take Acetaminophen 300mg/Codeine 30 mg every 6 hours as needed for pain until postoperative clinic visit |
| Measure Participants | 50 | 50 |
| Mean (Standard Deviation) [Pills] |
13.72
(8.04)
|
14.14
(9.77)
|
Adverse Events
| Time Frame | Adverse events were collected for the subjects time participating on the study. Participation began on the subject's surgery day and ended at their first clinical visit (6-8 days after surgery). | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | ||||
| Arm/Group Title | Acetaminophen/Ibuprofen | Acetaminophen/Codeine | ||
| Arm/Group Description | Group 1: Acetaminophen 650 mg; Ibuprofen 400 mg Acetaminophen/Ibuprofen: After hand surgery, take Acetaminophen 650 mg/Ibuprofen 400 mg every 6 hours as needed for pain until postoperative clinic visit | Group 2: Acetaminophen 300mg, Codeine 30 mg Acetaminophen/Codeine: After hand surgery, take Acetaminophen 300mg/Codeine 30 mg every 6 hours as needed for pain until postoperative clinic visit | ||
All Cause Mortality |
||||
| Acetaminophen/Ibuprofen | Acetaminophen/Codeine | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/70 (0%) | 0/70 (0%) | ||
Serious Adverse Events |
||||
| Acetaminophen/Ibuprofen | Acetaminophen/Codeine | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/70 (0%) | 0/70 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
| Acetaminophen/Ibuprofen | Acetaminophen/Codeine | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 32/70 (45.7%) | 30/70 (42.9%) | ||
| General disorders | ||||
| Nausea | 8/70 (11.4%) | 7/70 (10%) | ||
| Constipation | 8/70 (11.4%) | 12/70 (17.1%) | ||
| Itchiness | 12/70 (17.1%) | 11/70 (15.7%) | ||
| Dizziness | 3/70 (4.3%) | 2/70 (2.9%) | ||
| Drowsiness | 22/70 (31.4%) | 10/70 (14.3%) | ||
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Dr. Benjamin Gray |
|---|---|
| Organization | University of Pennsylvania |
| Phone | 215-294-9650 |
| Benjamin.Gray@uphs.upenn.edu |
Responsible Party:
University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT02647788
Other Study ID Numbers:
- BACH-2015, 823043
First Posted:
Jan 6, 2016
Last Update Posted:
Feb 18, 2019
Last Verified:
Feb 1, 2019