Ibuprofen Plus Acetaminophen Versus Oxycodone Alone After Hand Surgery

University of Southern California

Status and phase: Completed; Phase 2

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

Treatments: Drug: Ibuprofen 400 mg; Drug: Acetaminophen 650 mg; Drug: Oxycodone Hcl 5Mg

Study type: Interventional

Funder types: Other

Identifiers

NCT03111186

HS-15-00706

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Opiate group

Active Comparator group

Description:

Group receiving oxycodone alone (oxycodone HCl 5 mg up to six times daily as needed for pain)

Treatment:

Drug: Oxycodone Hcl 5Mg

Non-opiate group

Active Comparator group

Description:

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)

Treatment:

Drug: Ibuprofen 400 mg

Drug: Acetaminophen 650 mg