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
Overview
- Phase
- Phase 4
- Intervention
- Acetaminophen/Ibuprofen
- Conditions
- Pain, Postoperative
- Sponsor
- University of Pennsylvania
- Enrollment
- 144
- Locations
- 1
- Primary Endpoint
- Assessing Change in Pain Using the Visual Analogue Scale (VAS) Pain Score
- Status
- Completed
- Last Updated
- 7 years ago
Overview
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).
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients undergoing ambulatory hand surgery for carpal tunnel and trigger finger, under local anesthesia with or without sedation.
Exclusion Criteria
- •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
Arms & Interventions
Acetaminophen/Ibuprofen
Group 1: Acetaminophen 650 mg; Ibuprofen 400 mg
Intervention: Acetaminophen/Ibuprofen
Acetaminophen/Codeine
Group 2: Acetaminophen 300mg, Codeine 30 mg
Intervention: Acetaminophen/Codeine
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Number of Pills Used(From the time of surgery to first clinic visit (post-op day 6 to 8))
- Quality of Recovery-9 (QoR-9).(Postoperative Day 2)