Safe Options for ACL Recovery (SOAR)

Karen Derefinko, PhD

Status: Completed

Conditions: Anterior Cruciate Ligament Injuries; Opioid Use

Treatments: Behavioral: ACL Opioid Exposure Reduction Program

Study type: Interventional

Funder types: Other

Identifiers

NCT04225468

19-07075-XP

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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120 participants in 3 patient groups

Treatment As Usual (TAU)

No Intervention group

Description:

No intervention will be administered.

Opioid Exposure Reduction Program 1 (OERP1)

Experimental group

Description:

Participants will engage in a brief, educational intervention at their pre-surgery appointment approximately 2-3 weeks before ACL reconstruction surgery.

Treatment:

Behavioral: ACL Opioid Exposure Reduction Program

Opioid Exposure Reduction Program 2 (OERP2)

Experimental group

Description:

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.

Treatment:

Behavioral: ACL Opioid Exposure Reduction Program