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

Study Overview
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Brief Summary
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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
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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).

Official Title
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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

Conditions
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Pain, Postoperative

Intervention / Treatment
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* Drug: Acetaminophen/Ibuprofen
* Drug: Acetaminophen/Codeine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Acetaminophen/Ibuprofen<br>Group 1: Acetaminophen 650 mg; Ibuprofen 400 mg | Drug: Acetaminophen/Ibuprofen<br>* After hand surgery, take Acetaminophen 650 mg/Ibuprofen 400 mg every 6 hours as needed for pain until postoperative clinic visit<br>* Other names: Tylenol/Advil;|
| Active Comparator: Acetaminophen/Codeine<br>Group 2: Acetaminophen 300mg, Codeine 30 mg | Drug: Acetaminophen/Codeine<br>* After hand surgery, take Acetaminophen 300mg/Codeine 30 mg every 6 hours as needed for pain until postoperative clinic visit<br>* Other names: Tylenol 3;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessing Change in Pain Using the Visual Analogue Scale (VAS) Pain Score | 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. | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Recovery-9 (QoR-9). | 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. | Postoperative Day 2 | 
| Number of Pills Used |  | From the time of surgery to first clinic visit (post-op day 6 to 8) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pain, Postoperative