NCT04285853

Are Opioids Needed After ACL Reconstruction

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 98 (actual)
• Sponsor: Emory University · Academic / Other
• Sex: All
• Age: 14 Years – 40 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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. The purposes are to 1) conduct a double-blinded randomized controlled trial to determine the effectiveness of opioid versus non-opioid medications on post-surgical pain, and 2) examine predictors of opioid usage in individuals following Anterior Cruciate ligament (ACL) reconstruction. Patients will use an innovative Smartphone application to track pain and medication usage. Additionally, patients will complete quality of life and pain catastrophizing questionnaires, as well as undergo pain threshold testing, to be used in a model to determine predictors of greater post-surgical opioid use. This study will provide information on non-opioid alternatives and specific predictors of post-surgical opioid use that can be used to develop prescribing protocols. These findings will help orthopaedic surgeons make informed decisions when tailoring individualized prescriptions for patients following ACL reconstruction. Importantly, findings will be readily translatable into research to reduce opioid use in other orthopaedic surgical cohorts as well. Our ultimate goal is to lessen the burden of the opioid epidemic on not only our orthopaedic patients, but also society, by minimizing the number of opioids left in circulation.

Conditions

• Anterior Cruciate Ligament Rupture

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2020-09-16
• Primary completion: 2022-09-19
• Completion: 2022-09-19
• First posted: 2020-02-26
• Last updated: 2023-10-11
• Results posted: 2023-10-11

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study