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Clinical Trials/NCT04278703
NCT04278703
Unknown
Not Applicable

The Utilization of Opioid Medication Following ACL Reconstruction

Rothman Institute Orthopaedics1 site in 1 country192 target enrollmentFebruary 15, 2019

Overview

Phase
Not Applicable
Intervention
oxycodone
Conditions
Pain, Postoperative
Sponsor
Rothman Institute Orthopaedics
Enrollment
192
Locations
1
Primary Endpoint
Post-operative pain
Last Updated
6 years ago

Overview

Brief Summary

The purpose of this study is to evaluate the effectiveness of a post-operative opioid pain 18 management protocol for anterior cruciate ligament reconstruction (ACLR).

Registry
clinicaltrials.gov
Start Date
February 15, 2019
End Date
March 2021
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • All patients undergoing primary ACLR for ACL tear, including patients with concomitant 76 meniscectomy or meniscal repair.

Exclusion Criteria

  • Concomitant procedure other than meniscectomy or meniscal repair.
  • ACL revision
  • History of chronic pre-operative opioid use
  • History of substance abuse
  • Workmen's compensation claims
  • Pregnancy

Arms & Interventions

15 opioid tablets perscribed

For this treatment arm, patients will be given a prescription of 15 tablets of Oxycodone which they may take to alleviate post-operative pain

Intervention: oxycodone

25 opioid tablets perscribed

For this treatment arm, patients will be given a prescription of 15 tablets of Oxycodone which they may take to alleviate post-operative pain

Intervention: oxycodone

35 opioid tablets perscribed

For this treatment arm, patients will be given a prescription of 15 tablets of Oxycodone which they may take to alleviate post-operative pain

Intervention: oxycodone

Outcomes

Primary Outcomes

Post-operative pain

Time Frame: 14 days post-operative

Post-operative pain as reported by patients on a 0-10 VAS pain scale. 0 is no pain and 10 is worst pain imaginable

Study Sites (1)

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