CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 98 enrolled
Drug / intervention
Oxycodone +1 moredrug
Likely dose
Oxycodone 5 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04285853
NCT04285853Phase 4Completed
CompareCT.gov

Are Opioids Needed: A Double-Blinded, Randomized Controlled Trial and Examination of Predictors of Opioid Use Following ACL Reconstruction

Emory University·interventional·Posted Feb 26, 2020·Updated Oct 11, 2023

In Brief

A Phase 4 clinical trial evaluating Oxycodone and Placebo oral tablet for Anterior Cruciate Ligament Rupture. Completed, enrolled 98 participants across 3 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAnterior Cruciate Ligament Rupture
CountriesUnited States
CollaboratorsOrthopedic Research and Education Foundation

Timeline

Phase 4CompletedFinished
2020202120222023202420252026
First PostedFeb 26, 2020
Enrollment StartSep 16, 2020
Primary CompletionSep 19, 2022
TodayJul 2, 2026
Enrollment to primary: 2.0 yearsPosted 6.4 years ago

Interventions

Oxycodonedrug

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

Placebo oral tabletdrug

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