Are Opioids Needed After ACL Reconstruction

NCT ID: NCT04285853

Last Updated: 2023-10-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 98 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-16
• Study Completion Date: 2022-09-19

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.

Conditions

Anterior Cruciate Ligament Rupture

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Oxycodone Arm

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.

Group Type: EXPERIMENTAL

Oxycodone

Intervention Type: DRUG

5 mg oxycodone pills every 4-6 hrs if pain level 7 or higher on Numeric rating scale 1-10

Placebo Arm

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.

Group Type: PLACEBO_COMPARATOR

Placebo oral tablet

Intervention Type: DRUG

Placebo tablets (both trial and "rescue") will be matched to size, shape, color, and texture of oxycodone tablets.

Interventions

Oxycodone

5 mg oxycodone pills every 4-6 hrs if pain level 7 or higher on Numeric rating scale 1-10

Intervention Type: DRUG

Placebo oral tablet

Placebo tablets (both trial and "rescue") will be matched to size, shape, color, and texture of oxycodone tablets.

Intervention Type: DRUG

Other Intervention Names

Xtampza ER, Oxaydo, Roxicodone, and Oxycontin

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

• Minimum Eligible Age: 14 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Orthopedic Research and Education Foundation

OTHER

Sponsor Role: collaborator

Emory University

OTHER

Sponsor Role: lead

Responsible Party

John Xerogeanes

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

John Xerogeanes, MD

Role: PRINCIPAL_INVESTIGATOR

Emory University

Locations

The Emory Clinic

Atlanta, Georgia, United States

Emory clinic at Executive Park

Atlanta, Georgia, United States

Emory Orthopedic and spine Hospital

Tucker, Georgia, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

IRB00116728

Identifier Type: -

Identifier Source: org_study_id