Are Opioids Needed After ACL Reconstruction

Emory University

Status and phase: Completed; Phase 4

Conditions: Anterior Cruciate Ligament Rupture

Treatments: Drug: Placebo oral tablet; Drug: Oxycodone

Study type: Interventional

Funder types: Other

Identifiers

NCT04285853

IRB00116728

Details and patient eligibility

About

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.

Full 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.

Enrollment: 98 patients

Sex: All

Ages: 14 to 40 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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98 participants in 2 patient groups, including a placebo group

Oxycodone Arm

Experimental group

Description:

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.

Treatment:

Drug: Oxycodone

Placebo Arm

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo oral tablet