Clinical Trial: Ibuprofen Plus Acetaminophen Versus Oxycodone Alone After Hand Surgery

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

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

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 Summary: 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.
Sponsor: University of Southern California

Current Primary Outcome: change in VAS pain scale [ Time Frame: baseline, daily - up to 1 week postoperative ]

Visual Analog Score - pain scale, patient questionnaire


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • change in Brief Pain Index [ Time Frame: baseline, daily - up to 1 week postoperative ]
    Brief Pain Index - pain scale, patient questionnaire
  • change in pain diary [ Time Frame: baseline, daily - up to 1 week postoperative ]
    Pain Diary - pain scale, patient questionnaire


Original Secondary Outcome: Same as current

Information By: University of Southern California

Dates:
Date Received: April 6, 2017
Date Started: June 5, 2017
Date Completion: December 31, 2017
Last Updated: May 9, 2017
Last Verified: May 2017