Trial Outcomes & Findings for Acetaminophen/Codeine vs Acetaminophen/Ibuprofen for Pain Control and Patient Satisfaction After Hand Surgery (NCT NCT02647788)

Last Updated: 2019-02-18

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

144 participants

Primary outcome timeframe

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

Results posted on

2019-02-18

Participant Flow

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.

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.

Participant milestones

Participant milestones
Measure	Acetaminophen/Ibuprofen 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	Acetaminophen/Codeine 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
Overall Study STARTED	70	70
Overall Study COMPLETED	54	57
Overall Study NOT COMPLETED	16	13

Reasons for withdrawal

Reasons for withdrawal
Measure	Acetaminophen/Ibuprofen 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	Acetaminophen/Codeine 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
Overall Study Lost to Follow-up	13	11
Overall Study Did not want opiate	0	1
Overall Study Withdrawal by Subject	1	0
Overall Study Felt itchy with assigned medication	1	0
Overall Study Felt nauseous with assigned medication	1	1

Baseline Characteristics

Acetaminophen/Codeine vs Acetaminophen/Ibuprofen for Pain Control and Patient Satisfaction After Hand Surgery

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Acetaminophen/Ibuprofen n=54 Participants 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	Acetaminophen/Codeine n=57 Participants 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 n=111 Participants Total of all reporting groups
Age, Continuous	60 years STANDARD_DEVIATION 12 • n=5 Participants	59 years STANDARD_DEVIATION 13 • n=7 Participants	59 years STANDARD_DEVIATION 12 • n=5 Participants
Sex: Female, Male Female	37 Participants n=5 Participants	38 Participants n=7 Participants	75 Participants n=5 Participants
Sex: Female, Male Male	17 Participants n=5 Participants	19 Participants n=7 Participants	36 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	4 Participants n=5 Participants	1 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	17 Participants n=5 Participants	19 Participants n=7 Participants	36 Participants n=5 Participants
Race (NIH/OMB) White	32 Participants n=5 Participants	36 Participants n=7 Participants	68 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
VAS Pain Score	1.93 units on a scale STANDARD_DEVIATION 2.04 • n=5 Participants	2.50 units on a scale STANDARD_DEVIATION 2.51 • n=7 Participants	2.22 units on a scale STANDARD_DEVIATION 2.30 • n=5 Participants

PRIMARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Acetaminophen/Ibuprofen n=54 Participants 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	Acetaminophen/Codeine n=57 Participants 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
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	3.51 score on a scale Standard Deviation 2.69
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	2.40 score on a scale Standard Deviation 2.52
Assessing Change in Pain Using the Visual Analogue Scale (VAS) Pain Score VAS Pain Day 3	1.69 score on a scale Standard Deviation 2.00	2.26 score on a scale Standard Deviation 2.38
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	1.93 score on a scale Standard Deviation 2.01
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	1.48 score on a scale Standard Deviation 1.48
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	1.35 score on a scale Standard Deviation 1.37
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	1.01 score on a scale Standard Deviation 1.21

SECONDARY outcome

Timeframe: Postoperative Day 2

Population: Of the 111 subjects that completed the study, QoR score was available for 93 participants.

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.

Outcome measures

Outcome measures
Measure	Acetaminophen/Ibuprofen n=44 Participants 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	Acetaminophen/Codeine n=49 Participants 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
Quality of Recovery-9 (QoR-9).	16.91 Scores on a scale Standard Deviation 1.38	16.65 Scores on a scale Standard Deviation 1.91

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Acetaminophen/Ibuprofen n=50 Participants 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	Acetaminophen/Codeine n=50 Participants 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
Number of Pills Used	13.72 Pills Standard Deviation 8.04	14.14 Pills Standard Deviation 9.77

Adverse Events

Acetaminophen/Ibuprofen

Serious events: 0 serious events

Other events: 32 other events

Deaths: 0 deaths

Acetaminophen/Codeine

Serious events: 0 serious events

Other events: 30 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Acetaminophen/Ibuprofen n=70 participants at risk 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	Acetaminophen/Codeine n=70 participants at risk 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
General disorders Nausea	11.4% 8/70 • 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).	10.0% 7/70 • 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).
General disorders Constipation	11.4% 8/70 • 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).	17.1% 12/70 • 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).
General disorders Itchiness	17.1% 12/70 • 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).	15.7% 11/70 • 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).
General disorders Dizziness	4.3% 3/70 • 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).	2.9% 2/70 • 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).
General disorders Drowsiness	31.4% 22/70 • 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).	14.3% 10/70 • 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).

Additional Information

Dr. Benjamin Gray

University of Pennsylvania

Phone: 215-294-9650

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place