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Completed

NCT Number: NCT03111186

Ibuprofen Plus Acetaminophen Versus Oxycodone Alone After Hand Surgery

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Oxycodone Hcl 5Mg

Drug

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

Other names: oxycodone

Ibuprofen 400 mg

Drug

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

Acetaminophen 650 mg

Drug

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

Primary outcomes

  1. change in VAS pain scale

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

    Visual Analog Score - pain scale, patient questionnaire

Secondary outcomes

  1. change in Brief Pain Index

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

    Brief Pain Index - pain scale, patient questionnaire

  2. change in pain diary

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

    Pain Diary - pain scale, patient questionnaire

Sponsors and collaborators

Lead sponsor

University of Southern California

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Apr 12, 2017
Registry last updated
Sep 26, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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