Anterior Cruciate Ligament Pain Study

Emory University

Status and phase: Completed; Phase 4

Conditions: Anterior Cruciate Ligament Reconstruction

Treatments: Drug: Ropivacaine 0.5%; Drug: Percocet 7.5/325; Drug: Naprosyn 500 mg

Study type: Interventional

Funder types: Other

Identifiers

NCT02604550

IRB00083740

Details and patient eligibility

About

The objective of this study is to compare the pain control benefit of two different types of nerve blocks in patients undergoing anterior cruciate ligament (ACL) reconstruction.

Full description

This trial is a prospective, randomized, surgeon-blinded, two-armed trial to investigate the safety and efficacy of femoral nerve blocks versus adductor canal blocks for participants undergoing outpatient anterior cruciate ligament (ACL) reconstruction surgery.

The objective of this study is to compare the pain control benefit of two different types of nerve blocks. Ropivacaine, which is FDA-approved for use in both femoral nerve blocks as well as adductor canal blocks, will be utilized. The study will be comparing the efficacy between FDA approved treatments.

Enrollment: 115 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients undergoing scheduled anterior cruciate ligament (ACL) surgery at the Emory Orthopaedic and Spine Center
• Patients willing and able to provide written informed consent
• Parents willing and able to provide written informed consent for minors

Exclusion criteria

• Patients who are pregnant or lactating
• Patients with liver dysfunction or renal failure
• Patients with a known allergy to ropivacaine
• Patients with a local infection
• Patients who take chronic pain medications
• Patients with an opioid tolerance
• Patients with known coagulopathy or bleeding risk.
• Patients who are getting neuraxial anesthesia for surgery

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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115 participants in 2 patient groups

Femoral Nerve Block

Active Comparator group

Description:

Subjects undergoing anterior cruciate ligament (ACL) surgery will be randomized to receive 20 mL of ropivacaine 0.5% in the femoral nerve. Subjects will also receive standard of care Percocet 7.5/325 and naprosyn following surgery.

Treatment:

Drug: Naprosyn 500 mg

Drug: Ropivacaine 0.5%

Drug: Percocet 7.5/325

Adductor Canal Block

Active Comparator group

Description:

Subjects undergoing anterior cruciate ligament surgery will be randomized to receive 20 mL of ropivacaine 0.5% in the adductor canal. Subjects will also receive standard of care Percocet 7.5/325 and naprosyn following surgery.

Treatment:

Drug: Naprosyn 500 mg

Drug: Ropivacaine 0.5%

Drug: Percocet 7.5/325