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Completed

NCT Number: NCT04225468

Safe Options for ACL Recovery

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.

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Key information

Conditions

Anterior Cruciate Ligament Injuries Knee Injuries Leg Injuries Opioid Use Wounds and Injuries

Age range

12 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Tennessee Health Science Center

Memphis, Tennessee, 38163, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ACL Opioid Exposure Reduction Program

Behavioral

Subjects will engage in a brief, educational which includes information about the appropriate use of opioid pain medication, exposure and tolerance, the definition of misuse and opioid-related harms, how to wean off medication, alternative pain management strategies, and appropriate disposal of leftover medication.

Other names: ACL-OERP

Primary outcomes

  1. Total morphine milligram equivalents administered

    Time frame: Assessed at 30 days post surgery

    Cumulative morphine milligram equivalents self-administered following surgery; based upon pill counts

Secondary outcomes

  1. Knowledge of safe opioid use

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Karen Derefinko, PhD

Other

Collaborators

  • Campbell Clinic
  • University of Memphis

Registry information

Official study title

Safe Options for ACL Recovery: An Opioid Exposure Reduction Program for Anterior Cruciate Ligament Surgery Patients

Acronym: SOAR

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Jan 13, 2020
Registry last updated
Nov 2, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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