NCT03111186

Ibuprofen Plus Acetaminophen Versus Oxycodone Alone After Hand Surgery

A Randomized Trial Comparing Ibuprofen Plus Acetaminophen Versus Oxycodone Alone After Outpatient Soft Tissue Hand Surgery

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: University of Southern California · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

Type	Name	Description
DRUG	Oxycodone Hcl 5Mg	oxycodone HCl 5 mg up to six times daily as needed for pain
DRUG	Ibuprofen 400 mg	Ibuprofen 400 mg up to six times daily as needed for pain
DRUG	Acetaminophen 650 mg	Acetaminophen 650 mg up to four times daily as needed for pain

Timeline

• Start date: 2017-04-24
• Primary completion: 2019-05-01
• Completion: 2019-05-01
• First posted: 2017-04-12
• Last updated: 2019-09-26

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study