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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

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ClinicalTrials.gov Identifier: NCT03033589
Recruitment Status : Unknown
Verified January 2017 by Jonathan Lynch, Henry Ford Health System.
Recruitment status was:  Recruiting
First Posted : January 27, 2017
Last Update Posted : January 27, 2017
Sponsor:
Information provided by (Responsible Party):
Jonathan Lynch, 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.

Condition or disease Intervention/treatment Phase
Pain Drug: Marcaine 0.25 % Injectable Solution Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: Femoral Nerve Block Versus. Adductor Canal Nerve Block for Peri-Operative Analgesia Following Anterior Cruciate Ligament Reconstruction: Evaluation of Post-Operative Pain and Strength
Study Start Date : May 2016
Estimated Primary Completion Date : July 31, 2017
Estimated Study Completion Date : December 31, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Adductor Canal Nerve Block Drug: Marcaine 0.25 % Injectable Solution
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.

Active Comparator: Femoral Nerve block Drug: Marcaine 0.25 % Injectable Solution
For the femoral nerve block, 30 mL of 0.25% marcaine will be injected with the use of ultrasound guidance around the femoral nerve sheath by the attending anesthesiologist on the case in the pre-op holding area.




Primary Outcome Measures :
  1. Visual Analog Scale [ Time Frame: 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.

  2. Narcotic Requirement [ Time Frame: 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 :
  1. Thigh circumference [ Time Frame: 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.

  2. Straight Leg Raise [ Time Frame: 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).



Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03033589


Contacts
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Contact: Jonathan R Lynch, MD 260-750-2494 jlynch6@hfhs.org
Contact: Kelechi R Okoroha, MD 832-423-9895 kokoroh1@hfhs.org

Locations
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United States, Michigan
Henry Ford Health System - CFP 642 Recruiting
Detroit, Michigan, United States, 48202
Contact: Jonathan R Lynch, MD    260-750-2494    jlynch6@hfhs.org   
Contact: Kelechi Okoroha, MD    832-423-9895    kokoroh1@hfhs.org   
Sponsors and Collaborators
Henry Ford Health System
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Jonathan Lynch, Orthopaedic Surgery Resident, Henry Ford Health System
ClinicalTrials.gov Identifier: NCT03033589    
Other Study ID Numbers: 10083
First Posted: January 27, 2017    Key Record Dates
Last Update Posted: January 27, 2017
Last Verified: January 2017
Keywords provided by Jonathan Lynch, Henry Ford Health System:
Pain control
Anterior Cruciate Ligament (ACL_ Reconstruction)
Regional Anesthesia
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Bupivacaine
Pharmaceutical Solutions
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents