Acetaminophen/Codeine vs Acetaminophen/Ibuprofen for Pain Control and Patient Satisfaction After Hand Surgery
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|ClinicalTrials.gov Identifier: NCT02647788|
Recruitment Status : Completed
First Posted : January 6, 2016
Results First Posted : February 18, 2019
Last Update Posted : February 18, 2019
|Condition or disease||Intervention/treatment||Phase|
|Pain, Postoperative||Drug: Acetaminophen/Ibuprofen Drug: Acetaminophen/Codeine||Phase 4|
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).
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||144 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|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 :||December 2015|
|Actual Primary Completion Date :||January 19, 2018|
|Actual Study Completion Date :||January 19, 2018|
Active Comparator: Acetaminophen/Ibuprofen
Group 1: Acetaminophen 650 mg; Ibuprofen 400 mg
After hand surgery, take Acetaminophen 650 mg/Ibuprofen 400 mg every 6 hours as needed for pain until postoperative clinic visit
Other Name: Tylenol/Advil
Active Comparator: Acetaminophen/Codeine
Group 2: Acetaminophen 300mg, Codeine 30 mg
After hand surgery, take Acetaminophen 300mg/Codeine 30 mg every 6 hours as needed for pain until postoperative clinic visit
Other Name: Tylenol 3
- Assessing Change in Pain Using the Visual Analogue Scale (VAS) Pain Score [ 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 ]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.
- Quality of Recovery-9 (QoR-9). [ Time Frame: 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 [ Time Frame: From the time of surgery to first clinic visit (post-op day 6 to 8) ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02647788
|United States, Pennsylvania|
|University of Pennsylvania Health System|
|Philadelphia, Pennsylvania, United States, 19104|
|Principal Investigator:||David Steinberg, MD||University of Pennsylvania|