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

NCT03033589 | Completed

• 1 other identifier: 10083
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain

Keywords

Pain control; Anterior Cruciate Ligament (ACL_ Reconstruction); Regional Anesthesia

Outcome Measures

Primary Outcomes (2)

• Visual Analog Scale

  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.

  Post-op Day 0-5

• Narcotic Requirement

  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

  Post-op Day 0-5

Secondary Outcomes (2)

• Thigh circumference

  2 weeks post-operative vs 6 months post-operative

• Straight Leg Raise

  0-7 days post-operative

Study Arms (2)

Adductor Canal Nerve Block

ACTIVE COMPARATOR

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.

Drug: Marcaine 0.25 % Injectable Solution

Femoral Nerve block

ACTIVE COMPARATOR

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.

Drug: Marcaine 0.25 % Injectable Solution

Interventions

Marcaine 0.25 % Injectable Solution DRUG

For the adductor canal block, 20 mL of 0.25% marcaine will be injected with the use of ultrasound guidance into the adductor canal by the attending anesthesiologist on the case in the pre-op holding area.

Adductor Canal Nerve Block

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Henry Ford Health System: lead

Study Sites (1)

Henry Ford Health System - CFP 642

Detroit, Michigan, 48202, United States

Location

Related Publications (4)

• Guirro UB, Tambara EM, Munhoz FR. Femoral nerve block: Assessment of postoperative analgesia in arthroscopic anterior cruciate ligament reconstruction. Braz J Anesthesiol. 2013 Nov-Dec;63(6):483-91. doi: 10.1016/j.bjane.2013.09.001. Epub 2013 Dec 5.

  PMID: 24565346 BACKGROUND

• Luo TD, Ashraf A, Dahm DL, Stuart MJ, McIntosh AL. Femoral nerve block is associated with persistent strength deficits at 6 months after anterior cruciate ligament reconstruction in pediatric and adolescent patients. Am J Sports Med. 2015 Feb;43(2):331-6. doi: 10.1177/0363546514559823. Epub 2014 Dec 2.

  PMID: 25466410 BACKGROUND

• Kim DH, Lin Y, Goytizolo EA, Kahn RL, Maalouf DB, Manohar A, Patt ML, Goon AK, Lee YY, Ma Y, Yadeau JT. Adductor canal block versus femoral nerve block for total knee arthroplasty: a prospective, randomized, controlled trial. Anesthesiology. 2014 Mar;120(3):540-50. doi: 10.1097/ALN.0000000000000119.

  PMID: 24401769 BACKGROUND

• Lynch JR, Okoroha KR, Lizzio V, Yu CC, Jildeh TR, Moutzouros V. Adductor Canal Block Versus Femoral Nerve Block for Pain Control After Anterior Cruciate Ligament Reconstruction: A Prospective Randomized Trial. Am J Sports Med. 2019 Feb;47(2):355-363. doi: 10.1177/0363546518815874. Epub 2018 Dec 17.

  PMID: 30557034 DERIVED

MeSH Terms

Conditions

Pain; Agnosia

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Orthopedic Surgeon

Study Record Dates

• First Submitted: August 24, 2016
• First Posted: January 27, 2017
• Study Start: May 1, 2016
• Primary Completion: July 31, 2017
• Study Completion: December 31, 2017
• Last Updated: February 20, 2024

Record last verified: 2024-02

Locations

US (1)