Ibuprofen Plus Acetaminophen Versus Oxycodone Alone After Hand Surgery

Phase 2

Completed

• Conditions: Ganglion Cysts; Carpal Tunnel Syndrome; De Quervain Disease; Dupuytren Contracture; Trigger Digit
• Interventions: Drug: Oxycodone Hcl 5Mg; Drug: Ibuprofen 400 mg; Drug: Acetaminophen 650 mg

• Registration Number: NCT03111186
• Lead Sponsor: University of Southern California

Brief Summary

This study is about pain control and medication following outpatient soft-tissue hand surgery. We hope to learn if ibuprofen and acetaminophen will achieve similar pain relief and satisfaction when compared with oxycodone alone.

Detailed Description

Opiate analgesics remain the most popular option following outpatient hand surgery despite growing evidence that non-opiate analgesics may provide equivalent pain relief with fewer adverse effects and greater overall satisfaction. The purpose of this randomized trial is to compare the efficacy, side effect profiles and satisfaction associated with Ibuprofen plus Acetaminophen versus Oxycodone alone following outpatient hand surgery. No previous studies have compared the use of opiate analgesics with acetaminophen/ibuprofen following outpatient hand surgery. Patients will be randomized to receive either oxycodone alone or acetaminophen and ibuprofen following outpatient soft tissue hand surgery. Patients will be randomized to receive one of the two aforementioned pain regimens. Patients will be given a booklet in which to record pain level by visual analog scale (VAS), satisfaction with pain control, brief pain inventory and any side effects. Patients will be seen in clinic 1 week after surgery to review symptoms. Patients may also be contacted by phone to review daily log of symptoms. Patients will be seen in clinic 1 week after surgery per standard of care.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2017-04-06
• Study First Submitted QC: 2017-04-06
• Study First Posted: 2017-04-12
• Study Start: 2017-04-24
• Primary Completion: 2019-05-01
• Study Completion: 2019-05-01
• Status Verified: 2019-06
• Last Update Submitted: 2019-09-24
• Last Update Posted: 2019-09-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• age greater than 18 years
• scheduled to undergo elective outpatient soft tissue hand surgery for one of the following procedures: Carpal tunnel release, Dupuytren contracture release, trigger digit release, ganglion cyst removal, de Quervain's release.
• primary language is English or Spanish

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Exclusion Criteria

• any pre-existing condition requiring preoperative opiate analgesia, eg chronic pain syndrome
• allergy to acetaminophen, ibuprofen, or oxycodone
• renal impairment or liver disease either documented based on history or when preoperative creatinine, BUN, or liver function tests are outside the normal range provided by the lab
• peptic ulcer disease or any history of gastrointestinal bleeding
• coagulopathy documented on history, review of systems, or based on preoperative lab testing where PT, PTT, or INR are outside the normal range provided by the lab
• pregnancy based on positive beta-HCG test which is performed on the day of the surgical procedure as is standard protocol

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Opiate group	Oxycodone Hcl 5Mg	Group receiving oxycodone alone (oxycodone HCl 5 mg up to six times daily as needed for pain)
Non-opiate group	Ibuprofen 400 mg	Group receiving ibuprofen and acetaminophen (acetaminophen 650 mg up to four times daily and ibuprofen 400 mg up to six times daily as need for pain)
Non-opiate group	Acetaminophen 650 mg	Group receiving ibuprofen and acetaminophen (acetaminophen 650 mg up to four times daily and ibuprofen 400 mg up to six times daily as need for pain)

Primary Outcome Measures

Name	Time	Method
change in VAS pain scale	baseline, daily - up to 1 week postoperative	Visual Analog Score - pain scale, patient questionnaire

Secondary Outcome Measures

Name	Time	Method
change in Brief Pain Index	baseline, daily - up to 1 week postoperative	Brief Pain Index - pain scale, patient questionnaire
change in pain diary	baseline, daily - up to 1 week postoperative	Pain Diary - pain scale, patient questionnaire

Trial Locations

Locations (1)

Keck School of Medicine of the University of Southern California; 🇺🇸 Los Angeles, California, United States