Are Opioids Needed After ACL Reconstruction

Study Overview
=================
Brief Summary
-----------------
As the public health sector continues to confront the opioid epidemic, orthopaedic surgeons must revisit pain management protocols to reduce unnecessary opioid prescriptions. The long-term goal is to reduce opioid use and residual opioids in circulation.

Detailed Description
-----------------
As the public health sector continues to confront the opioid epidemic, orthopaedic surgeons must revisit pain management protocols to reduce unnecessary opioid prescriptions. The long-term goal is to reduce opioid use and residual opioids in circulation. The purposes are to 1) conduct a double-blinded randomized controlled trial to determine the effectiveness of opioid versus non-opioid medications on post-surgical pain, and 2) examine predictors of opioid usage in individuals following Anterior Cruciate ligament (ACL) reconstruction. Patients will use an innovative Smartphone application to track pain and medication usage. Additionally, patients will complete quality of life and pain catastrophizing questionnaires, as well as undergo pain threshold testing, to be used in a model to determine predictors of greater post-surgical opioid use. This study will provide information on non-opioid alternatives and specific predictors of post-surgical opioid use that can be used to develop prescribing protocols. These findings will help orthopaedic surgeons make informed decisions when tailoring individualized prescriptions for patients following ACL reconstruction. Importantly, findings will be readily translatable into research to reduce opioid use in other orthopaedic surgical cohorts as well. Our ultimate goal is to lessen the burden of the opioid epidemic on not only our orthopaedic patients, but also society, by minimizing the number of opioids left in circulation.

Official Title
-----------------
Are Opioids Needed: A Double-Blinded, Randomized Controlled Trial and Examination of Predictors of Opioid Use Following ACL Reconstruction

Conditions
-----------------
Anterior Cruciate Ligament Rupture

Intervention / Treatment
-----------------
* Drug: Oxycodone
* Drug: Placebo oral tablet


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Males and females Aged 14-40 years Scheduled for primary (Anterior cruciate ligament) ACL reconstruction using quadriceps tendon autograft. Exclusion Criteria: Revision and/or contralateral ACL reconstruction procedures Allergies to local anesthetics Chronic pain medication use Weight <50 kg, local infections Known coagulopathies, Liver dysfunction or renal failure

Ages Eligible for Study
-----------------
Minimum Age: 14 Years
Maximum Age: 40 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Prospective, double-blind, randomized controlled clinical trial
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Oxycodone Arm<br>Patients in this opioid group will receive 15 oral opioid tablets (5 mg oxycodone) Patients will also receive 8 rescue medications, in the Oxycodone arm will be placebo rescue medications. All participants will also receive the following as part of standard of care: Oral non-opioid (1000 mg acetaminophen), every 8 hours. Prescription of non-opioid non-steroidal anti-inflammatory medication (naproxen 500 mg) to be used 2x/day post-surgery. Standardized multimodal intra- and post-operative protocols, including an adductor canal peripheral nerve block. Intraoperative education on post-surgical pain management. | Drug: Oxycodone<br>* 5 mg oxycodone pills every 4-6 hrs if pain level 7 or higher on Numeric rating scale 1-10<br>* Other names: Xtampza ER, Oxaydo, Roxicodone, and Oxycontin;|
| Placebo Comparator: Placebo Arm<br>Patients in placebo group will receive 15 placebo tablets. All patients will also receive 8 rescue medications: Patients who randomize to the non-opioid arm will receive 5mg oxycodone rescue tablets. All participants will also receive the following as part of standard of care: Oral non-opioid (1000 mg acetaminophen), every 8 hours. Prescription of non-opioid non-steroidal anti-inflammatory medication (naproxen 500 mg) to be used 2x/day post-surgery. Standardized multimodal intra- and post-operative protocols, including an adductor canal peripheral nerve block. Intraoperative education on post-surgical pain management. | Drug: Placebo oral tablet<br>* Placebo tablets (both trial and rescue) will be matched to size, shape, color, and texture of oxycodone tablets.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Level: Numeric Rating Scale | Patients will record pain levels on Numeric Rating Scale 1-10, where 1 is minimal pain and 10 is associated with highest level of pain (worse outcome). | Postoperative days 0-6 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Opioids