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Clinical Trials/NCT03597308
NCT03597308
Completed
Not Applicable

PROSPECTIVE RANDOMIZED CONTROLLED TRIAL COMPARING OXYCODONE, IBUPROFEN AND ACETAMINOPHEN AFTER WIDE AWAKE HAND SURGERY

Rothman Institute Orthopaedics1 site in 1 country210 target enrollmentMarch 17, 2017

Overview

Phase
Not Applicable
Intervention
5mg of Oxycodone every 6 hours as needed for pain
Conditions
Post-operative Pain
Sponsor
Rothman Institute Orthopaedics
Enrollment
210
Locations
1
Primary Endpoint
Numeric rating Scale for Pain
Status
Completed
Last Updated
7 years ago

Overview

Brief Summary

The purpose of the study is to evaluate the efficacy of three different types of pain medication (Oxycodone - an opioid, Ibuprofen - a non-steroidal anti-inflammatory, and Acetaminophen - a non-opioid analgesic) in the management of postoperative pain following single soft tissue procedures of the hand and wrist performed exclusively under local anesthesia without sedation. The results of this study will help define optimal prescribing guidelines following the two most common hand surgeries while also potentially validating the use of opioid alternatives post-operatively in order to help mitigate excessive or unnecessary dispensal of opioid analgesics.

Registry
clinicaltrials.gov
Start Date
March 17, 2017
End Date
August 1, 2017
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Arms & Interventions

Opioid Group

Intervention: 5mg of Oxycodone every 6 hours as needed for pain

NSAID group

Intervention: 600mg of Ibuprofen every 6 hours as needed for pain

Acetaminophen

Intervention: 500mg of Acetaminophen every 6 hours as needed for pain

Outcomes

Primary Outcomes

Numeric rating Scale for Pain

Time Frame: 2 weeks post-op

11-point numeric rating scale (NRS) for pain

Study Sites (1)

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