Ibuprofen Plus Acetaminophen Versus Oxycodone Alone After Hand Surgery

September 24, 2019 updated by: Alidad Ghiassi, University of Southern California

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90033
        • Keck School of Medicine of the University of Southern California

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Opiate group
Group receiving oxycodone alone (oxycodone HCl 5 mg up to six times daily as needed for pain)
Drug: Oxycodone Hcl 5Mg
oxycodone HCl 5 mg up to six times daily as needed for pain
Other Names:
  • oxycodone
Active Comparator: Non-opiate group
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)
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change in VAS pain scale
Time Frame: baseline, daily - up to 1 week postoperative
Visual Analog Score - pain scale, patient questionnaire
baseline, daily - up to 1 week postoperative

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change in Brief Pain Index
Time Frame: baseline, daily - up to 1 week postoperative
Brief Pain Index - pain scale, patient questionnaire
baseline, daily - up to 1 week postoperative
change in pain diary
Time Frame: baseline, daily - up to 1 week postoperative
Pain Diary - pain scale, patient questionnaire
baseline, daily - up to 1 week postoperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Southern California

Investigators

  • Principal Investigator: Alidad Ghiassi, MD, University of Southern California

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 24, 2017

Primary Completion (Actual)

May 1, 2019

Study Completion (Actual)

May 1, 2019

Study Registration Dates

First Submitted

April 6, 2017

First Submitted That Met QC Criteria

April 6, 2017

First Posted (Actual)

April 12, 2017

Study Record Updates

Last Update Posted (Actual)

September 26, 2019

Last Update Submitted That Met QC Criteria

September 24, 2019

Last Verified

June 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HS-15-00706

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

Data will be shared as required with the USC Health Sciences Institutional Review Board. Participant data will be coded with coding identifiers kept separately by research personnel only and destroyed upon completion of the study.

Study Data/Documents

  1. Study Protocol
    Information identifier: HS-15-00706
  2. Informed Consent Form
    Information identifier: HS-15-00706

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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