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.
Full Title of Study: “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 Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Treatment
- Masking: Double (Participant, Investigator)
- Study Primary Completion Date: January 19, 2018
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).
- Drug: Acetaminophen/Ibuprofen
- After hand surgery, take Acetaminophen 650 mg/Ibuprofen 400 mg every 6 hours as needed for pain until postoperative clinic visit
- Drug: Acetaminophen/Codeine
- After hand surgery, take Acetaminophen 300mg/Codeine 30 mg every 6 hours as needed for pain until postoperative clinic visit
Arms, Groups and Cohorts
- Active Comparator: Acetaminophen/Ibuprofen
- Group 1: Acetaminophen 650 mg; Ibuprofen 400 mg
- Active Comparator: Acetaminophen/Codeine
- Group 2: Acetaminophen 300mg, Codeine 30 mg
Clinical Trial Outcome Measures
- 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)
Participating in This Clinical Trial
- 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
Gender Eligibility: All
Minimum Age: 18 Years
Maximum Age: N/A
Are Healthy Volunteers Accepted: No
- Lead Sponsor
- University of Pennsylvania
- Provider of Information About this Clinical Study
- Overall Official(s)
- David Steinberg, MD, Principal Investigator, University of Pennsylvania
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