Anterior Cruciate Ligament Injuries, Opioid Use
Conditions
Keywords
prevention, opioid exposure, exposure reduction
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.
Interventions
BEHAVIORALACL 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.
Sponsors
University of Memphis
Campbell Clinic
Karen Derefinko, PhD
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total morphine milligram equivalents administered | Assessed at 30 days post surgery | Cumulative morphine milligram equivalents self-administered following surgery; based upon pill counts |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Outcome results
None listed