Are Opioids Needed After ACL Reconstruction

Phase 4

Completed

Conditions: Anterior Cruciate Ligament Rupture

Interventions: Drug: Placebo oral tablet
Drug: Oxycodone

Registration Number: NCT04285853

Lead Sponsor: Emory University

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 98

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo Arm	Placebo oral tablet	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: 1. Oral non-opioid (1000 mg acetaminophen), every 8 hours. 2. Prescription of non-opioid non-steroidal anti-inflammatory medication (naproxen 500 mg) to be used 2x/day post-surgery. 3. Standardized multimodal intra- and post-operative protocols, including an adductor canal peripheral nerve block. 4. Intraoperative education on post-surgical pain management.
Oxycodone Arm	Oxycodone	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: 1. Oral non-opioid (1000 mg acetaminophen), every 8 hours. 2. Prescription of non-opioid non-steroidal anti-inflammatory medication (naproxen 500 mg) to be used 2x/day post-surgery. 3. Standardized multimodal intra- and post-operative protocols, including an adductor canal peripheral nerve block. 4. Intraoperative education on post-surgical pain management.

Primary Outcome Measures

Name	Time	Method
Pain Level: Numeric Rating Scale	Postoperative days 0-6	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).

Secondary Outcome Measures

Name	Time	Method

Trial Locations

Locations (3): Emory clinic at Executive Park
🇺🇸
Atlanta, Georgia, United States
The Emory Clinic
🇺🇸
Atlanta, Georgia, United States
Emory Orthopedic and spine Hospital
🇺🇸
Tucker, Georgia, United States