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
Primary Purpose
Pain
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Marcaine 0.25 % Injectable Solution
Marcaine 0.25 % Injectable Solution
Sponsored by
About this trial
This is an interventional treatment trial for Pain focused on measuring Pain control, Anterior Cruciate Ligament (ACL_ Reconstruction), Regional Anesthesia
Eligibility 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.
Sites / Locations
- Henry Ford Health System - CFP 642Recruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Adductor Canal Nerve Block
Femoral Nerve block
Arm Description
Outcomes
Primary Outcome Measures
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.
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
Secondary Outcome Measures
Thigh circumference
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
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).
Full Information
NCT ID
NCT03033589
First Posted
August 24, 2016
Last Updated
January 26, 2017
Sponsor
Henry Ford Health System
1. Study Identification
Unique Protocol Identification Number
NCT03033589
Brief Title
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
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 Type
Interventional
2. Study Status
Record Verification Date
January 2017
Overall Recruitment Status
Unknown status
Study Start Date
May 2016 (undefined)
Primary Completion Date
July 31, 2017 (Anticipated)
Study Completion Date
December 31, 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Henry Ford Health System
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain
Keywords
Pain control, Anterior Cruciate Ligament (ACL_ Reconstruction), Regional Anesthesia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Adductor Canal Nerve Block
Arm Type
Active Comparator
Arm Title
Femoral Nerve block
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Marcaine 0.25 % Injectable Solution
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Marcaine 0.25 % Injectable Solution
Intervention Description
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 Measure Information:
Title
Visual Analog Scale
Description
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.
Time Frame
Post-op Day 0-5
Title
Narcotic Requirement
Description
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
Time Frame
Post-op Day 0-5
Secondary Outcome Measure Information:
Title
Thigh circumference
Description
Thigh circumference will be measured 10 cm above the superior pole of the patella for both the operative and non-operative thighs.
Time Frame
2 weeks post-operative vs 6 months post-operative
Title
Straight Leg Raise
Description
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).
Time Frame
0-7 days post-operative
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jonathan R Lynch, MD
Phone
260-750-2494
Email
jlynch6@hfhs.org
First Name & Middle Initial & Last Name or Official Title & Degree
Kelechi R Okoroha, MD
Phone
832-423-9895
Email
kokoroh1@hfhs.org
Facility Information:
Facility Name
Henry Ford Health System - CFP 642
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jonathan R Lynch, MD
Phone
260-750-2494
Email
jlynch6@hfhs.org
First Name & Middle Initial & Last Name & Degree
Kelechi Okoroha, MD
Phone
832-423-9895
Email
kokoroh1@hfhs.org
12. IPD Sharing Statement
Citations:
PubMed Identifier
24565346
Citation
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.
Results Reference
background
PubMed Identifier
25466410
Citation
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.
Results Reference
background
PubMed Identifier
24401769
Citation
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.
Results Reference
background
PubMed Identifier
30557034
Citation
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.
Results Reference
derived
Learn more about this trial
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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