Safe Options for ACL Recovery

Not Applicable

Completed

• Conditions: Anterior Cruciate Ligament Injuries; Opioid Use
• Interventions: Behavioral: ACL Opioid Exposure Reduction Program

• Registration Number: NCT04225468
• Lead Sponsor: Karen Derefinko, PhD

Brief Summary

The purpose of the proposed work is to test a brief opioid exposure reduction program (ACL-OERP) designed to improve health literacy about opioid use following surgeries. This intervention is specifically designed to be used with patients (or for patients under 18, the patient and caregiver) undergoing Anterior Cruciate Ligament (ACL) reconstruction, a painful surgery that is often followed by at least 7 days of opioid medication.

Detailed Description

The goal of this study is to test whether the ACL-OERP intervention (vs. a treatment as usual \[TAU\] comparison) improves knowledge of (1) risks associated with opioid self-administration (development of tolerance, dangers of concomitant sedative use, taking as prescribed for safety), (2) expected pain following ACL reconstruction, (3) accurate pain assessment, (4) and weaning from opioid to non-narcotic analgesics.

There will be one control arm (TAU) and two intervention arms, both of which are experimental. Both will receive the ACL-OERP before surgery, and the second arm will also receive a "booster" intervention session of the intervention 3 days after surgery.

In addition, investigators wish to compare the amount of opioid self-administered in the intervention groups (vs. TAU comparison) to assess whether this knowledge reduces self-administration of opioid. The project will also examine whether the implementation of the booster intervention session in the third arm improves these outcomes compared to the other intervention arm.

Study Timeline

• Study First Submitted: 2020-01-07
• Study First Submitted QC: 2020-01-08
• Study First Posted: 2020-01-13
• Study Start: 2020-02-12
• Primary Completion: 2022-06-03
• Study Completion: 2022-06-03
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-31
• Last Update Posted: 2022-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• Presenting for a pre-operatory appointment at the study site for ACL reconstruction with patellar tendon autograft surgery.
• Be able to return to the clinic at least one time within the first 10 days post-op.

Exclusion Criteria

• Under 12 years of age
• Contraindication to opioids
• Unable to understand intervention material in English

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Opioid Exposure Reduction Program 2 (OERP2)	ACL Opioid Exposure Reduction Program	Participants will engage in the same intervention as OERP1, but those in OERP2 will also receive a 5-minute "booster" intervention session 3 days after surgery.
Opioid Exposure Reduction Program 1 (OERP1)	ACL Opioid Exposure Reduction Program	Participants will engage in a brief, educational intervention at their pre-surgery appointment approximately 2-3 weeks before ACL reconstruction surgery.

Primary Outcome Measures

Name	Time	Method
Total morphine milligram equivalents administered	Assessed at 30 days post surgery	Cumulative morphine milligram equivalents self-administered following surgery; based upon pill counts

Secondary Outcome Measures

Name	Time	Method
Knowledge of safe opioid use	Assessed at baseline and 7-days post surgery	Change in pre and post test scores of a knowledge test of topics covered in the intervention including tolerance, weaning off opioids, safe disposal methods, and alternative pain management strategies.

Trial Locations

Locations (1)

University of Tennessee Health Science Center; 🇺🇸 Memphis, Tennessee, United States