Ibuprofen Plus Acetaminophen Versus Oxycodone Alone After Hand Surgery

University of Southern California40 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Carpal Tunnel Syndrome Dupuytren Contracture Trigger Digit Ganglion Cysts De Quervain Disease

Interventions

Oxycodone Hcl 5MgDRUG

oxycodone HCl 5 mg up to six times daily as needed for pain

Ibuprofen 400 mgDRUG

Ibuprofen 400 mg up to six times daily as needed for pain

Acetaminophen 650 mgDRUG

Acetaminophen 650 mg up to four times daily as needed for pain

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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 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

Locations (1)

Keck School of Medicine of the University of Southern California

Los Angeles, California, United States

Outcomes

Primary Outcomes

change in VAS pain scale

Visual Analog Score - pain scale, patient questionnaire

Time frame: baseline, daily - up to 1 week postoperative

Secondary Outcomes

change in Brief Pain Index

Brief Pain Index - pain scale, patient questionnaire

Time frame: baseline, daily - up to 1 week postoperative

change in pain diary

Pain Diary - pain scale, patient questionnaire

Time frame: baseline, daily - up to 1 week postoperative

Data from ClinicalTrials.gov

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