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Clinical Trials/NCT03597308
NCT03597308CompletedNot Applicable

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

Rothman Institute Orthopaedics1 site in 1 country210 target enrollmentStarted: March 17, 2017Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
210
Locations
1
Primary Endpoint
Numeric rating Scale for Pain

Study 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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Arms & Interventions

Opioid Group

Active Comparator

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

NSAID group

Active Comparator

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

Acetaminophen

Active Comparator

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

Outcomes

Primary Outcomes

Numeric rating Scale for Pain

Time Frame: 2 weeks post-op

11-point numeric rating scale (NRS) for pain

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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