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

Phase 4

Completed

• Conditions: Pain, Postoperative
• Interventions: Drug: Acetaminophen/Ibuprofen; Drug: Acetaminophen/Codeine

• Registration Number: NCT02647788
• Lead Sponsor: University of Pennsylvania

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).

Study Timeline

• Study Start: 2015-12
• Study First Submitted: 2016-01-04
• Study First Submitted QC: 2016-01-05
• Study First Posted: 2016-01-06
• Primary Completion: 2018-01-19
• Study Completion: 2018-01-19
• Results First Submitted: 2019-01-18
• Status Verified: 2019-02
• Results First Submitted QC: 2019-02-12
• Last Update Submitted: 2019-02-12
• Results First Posted: 2019-02-18
• Last Update Posted: 2019-02-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 144

Inclusion Criteria

• Patients undergoing ambulatory hand surgery for carpal tunnel and trigger finger, under local anesthesia with or without sedation.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Acetaminophen/Ibuprofen	Acetaminophen/Ibuprofen	Group 1: Acetaminophen 650 mg; Ibuprofen 400 mg
Acetaminophen/Codeine	Acetaminophen/Codeine	Group 2: Acetaminophen 300mg, Codeine 30 mg

Primary Outcome Measures

Name	Time	Method
Assessing Change in Pain Using the Visual Analogue Scale (VAS) Pain Score	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 Outcome Measures

Name	Time	Method
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	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.

Trial Locations

Locations (1)

University of Pennsylvania Health System; 🇺🇸 Philadelphia, Pennsylvania, United States