Femoral Nerve Block Versus Adductor Canal Nerve Block for Peri-Operative Analgesia Following Anterior Cruciate Ligament (ACL) Reconstruction: Evaluation of Post-operative Pain and Strength

Not Applicable

Completed

• Conditions: Pain
• Interventions: Drug: Marcaine 0.25 % Injectable Solution

• Registration Number: NCT03033589
• Lead Sponsor: Henry Ford Health System

Brief Summary

All patients over the age of 16 undergoing primary or revision anterior cruciate ligament reconstruction with the use of bone-patellar-bone autograft are eligible for the study. Patients will be randomized pre-operatively to receive either an adductor canal nerve block (single injection) or a femoral nerve block (single injection). Post-operatively, the primary outcome measures of pain level using visual analog scale as well as narcotic and non-narcotic analgesic requirements will be measured.

Detailed Description

Currently, because of its good track record, femoral nerve block is the modality of choice for post-operative pain control following elective anterior cruciate ligament reconstruction at our institution. It has been proven in the literature to provide good post-operative pain analgesia following this procedure (1). However, femoral nerve block is not without its concerns, including the concern for long-term quadriceps weakness (2). Benefits of decreased use of Femoral Nerve Block include the decreased incidence of side effects and/or complications, and use of quadriceps for immediate rehabilitation. Benefits of Adductor canal nerve block include possible equivalent pain control with the avoidance of motor de-innervation and its deleterious adverse effect of quadriceps weakness postoperatively. Adductor canal nerve block has proven to be effective in other orthopaedic procedures involving the knee including total knee arthroplasty (3). This results of this study will give more information on how to better control pain in the post-op period while minimizing the deleterious side effects for patients undergoing ACLreconstruction.

All patients over the age of 16 undergoing primary or revision anterior cruciate ligament reconstruction with the use of bone-patellar-bone autograft are eligible for the study. Patients will be randomized pre-operatively to receive either an adductor canal nerve block (single injection) or a femoral nerve block (single injection). A single dose of 30 mL of 0.25% marcaine is injected for femoral nerve block and 20 mL of 0.25% marcaine for Adductor Canal nerve block. These procedures will be performed by the attending anesthesiologist prior to surgery. After surgery the patient will record their pain levels using visual analog scale (VAS) score in a daily diary for the first 5 post-operative days. They will also record all medication requirements, both narcotic and non-narcotic analgesic medications. The patient will be tested on their ability to perform a straight leg raise in the post-anesthesia care unit (PACU) and at their first post-operative visit.

Study Timeline

• Study Start: 2016-05
• Study First Submitted: 2016-08-24
• Study First Submitted QC: 2017-01-26
• Study First Posted: 2017-01-27
• Primary Completion: 2017-07-31
• Study Completion: 2017-12-31
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-15
• Last Update Posted: 2024-02-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 78

Inclusion Criteria

• Primary ACL Reconstruction with use of Bone-Patellar-Bone Autograft
• Age 16 or older

Exclusion Criteria

• Patients under 16
• The use of Allograft,
• The use of hamstring autograft
• The use quadriceps autograft
• Patients allergic to active ingredients in the injection.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Adductor Canal Nerve Block	Marcaine 0.25 % Injectable Solution	One hour prior to procedure, subject to receive 20 mL of 0.5% ropivacaine injected into the sheath of the saphenous nerve at the adductor hiatus. Ultrasound guidance utilized for appropriate localization of the targeted nerve sheath for local infiltration. No nerve stimulators to be utilized during or after the procedure.
Femoral Nerve block	Marcaine 0.25 % Injectable Solution	One hour prior to procedure, subject to receive 30 mL of 0.5% ropivacaine injected into the nerve sheath of the femoral nerve at the level of the femoral triangle. Ultrasound guidance utilized for appropriate localization of the targeted nerve sheath for local infiltration. No nerve stimulators to be utilized during or after the procedure.

Primary Outcome Measures

Name	Time	Method
Visual Analog Scale	Post-op Day 0-5	Every 4 hours the patient will record in their study binder their pain level on a scale from 1-10. They are instructed that a 1 signifies minimal pain that is nearly unnoticeable whereas a pain scale of 10 is the most intolerable pain imaginable.
Narcotic Requirement	Post-op Day 0-5	Every time a the prescribed narcotic is consumed, in this study it is Norco 5-325 (Hydrocodone-Acetaminophen), the subject is instructed to log their quantity consumed as well as the time consumed in the study binder provided to them

Secondary Outcome Measures

Name	Time	Method
Thigh circumference	2 weeks post-operative vs 6 months post-operative	Thigh circumference will be measured 10 cm above the superior pole of the patella for both the operative and non-operative thighs.
Straight Leg Raise	0-7 days post-operative	We will test the ability to perform straight leg raise in post-anesthesia care unit as well as at first post-operative visit (5-7 days post-operative).

Trial Locations

Locations (1)

Henry Ford Health System - CFP 642; 🇺🇸 Detroit, Michigan, United States