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Are Opioids Needed After ACL Reconstruction

NCT04285853 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 98

Last updated 2023-10-11

Study results available
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Summary

As the public health sector continues to confront the opioid epidemic, orthopaedic surgeons must revisit pain management protocols to reduce unnecessary opioid prescriptions. The long-term goal is to reduce opioid use and residual opioids in circulation.

Conditions

  • Anterior Cruciate Ligament Rupture

Interventions

DRUG

Oxycodone

5 mg oxycodone pills every 4-6 hrs if pain level 7 or higher on Numeric rating scale 1-10

DRUG

Placebo oral tablet

Placebo tablets (both trial and "rescue") will be matched to size, shape, color, and texture of oxycodone tablets.

Sponsors & Collaborators

  • Orthopedic Research and Education Foundation

    collaborator OTHER

  • Emory University

    lead OTHER

Principal Investigators

  • John Xerogeanes, MD · Emory University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
14 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-16
Primary Completion
2022-09-19
Completion
2022-09-19
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04285853 on ClinicalTrials.gov