Safe Options for ACL Recovery

Opioid Use Clinical Trial

— SOAR  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04225468
• Other study ID #: 19-07075-XP
• Status: Completed
• Phase: N/A
• Start date: February 12, 2020
• Est. completion date: June 3, 2022

Study information

• Verified date: October 2022
• Source: University of Tennessee
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: June 3, 2022
• Est. primary completion date: June 3, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anterior Cruciate Ligament Injuries
• Opioid Use

Intervention

Behavioral:
• ACL Opioid Exposure Reduction Program
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.

Locations

Country	Name	City	State
United States	University of Tennessee Health Science Center	Memphis	Tennessee

Sponsors (3)

Lead Sponsor	Collaborator
Karen Derefinko, PhD	Campbell Clinic, University of Memphis

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total morphine milligram equivalents administered	Cumulative morphine milligram equivalents self-administered following surgery; based upon pill counts	Assessed at 30 days post surgery
Secondary	Knowledge of safe opioid use	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.	Assessed at baseline and 7-days post surgery

External Links

•   UTHSC main website