- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02554864
Location of Injection of Local Anesthetics in the Adductor Canal Block (LILAC)
February 25, 2019 updated by: Women's College Hospital
Location of Injection of Local Anesthetics in the Adductor Canal Block: A Randomized Controlled Trial of the Effect on Postoperative Analgesia and Motor Power
The adductor canal block (ACB) is the standard of care for analgesia after Anterior Cruciate Ligament (ACL) repair.
ACB is performed by injecting local anesthetic (freezing) in the subsartorial canal in the thigh which is about 7-10cm long.
Preliminary evidence suggests that different injection sites within the canal may produce different degrees of analgesia and quadriceps motor block.
This trial seeks to determine the effects of various ACB injection sites on postoperative analgesia and motor power following ACL repair.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Adductor canal block (ACB) is replacing femoral nerve block (FNB) as the peripheral nerve block of choice for knee surgery.
The ACB aims to inject local anesthetics (LA) within the neurovascular sheath in the subsartorial adductor canal around the femoral nerve.
The point where the sartorius muscle crosses over the femoral artery is generally the accepted site for performing ACB.
Clinically, injecting LA in the adductor canal blocks the sensory innervation of the knee and thus offers pain relief that is similar to FNB while conserving motor power around the knee.
While these benefits are desirable, the exact location for performing ACB that ensures these benefits, remains debatable.
The subsartorial adductor canal itself is 7-10cm long and the anatomical location of the sensory and motor nerves that innervate the knee and its surrounding muscles in this canal may vary.
This randomized controlled trial is designed to identify and refine the ACB technique by clinically determining the effects of various ACB injection locations on postoperative analgesia and quadriceps motor power following ACL repair.
Study Type
Interventional
Enrollment (Actual)
108
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ontario
-
Toronto, Ontario, Canada, M5S 1B2
- Women's College Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
14 years to 46 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patients booked for anterior cruciate ligament surgery under general anesthesia
- English speaking
- BMI <38 kg/m2
Exclusion Criteria:
- Refusal or inability to provide informed consent
- Allergy to local anesthetics
- Contraindication to regional anesthesia including coagulopathy or bleeding - diathesis
- Infection
- Nerve Injury at the site of the nerve block
- Malignancy at the site of the nerve block
- History of drug and/or alcohol dependence
- History of long term opioid intake or chronic pain disorder
- History of pre-existing neuropathy in the operative leg
- History of significant psychiatric conditions that may affect patient assessment
- Inability to understand the informed consent and demands of the study
- Allergy to any of the components of multi-modal analgesic regimen
- Revision ACL repair
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Adductor Canal Block- Injection -Site A
AC Block-Injection (lidocaine 2% and ropivacaine 1%) Site A - after the sartorius muscle crosses over the femoral artery
|
Local anesthetic
Other Names:
Local anesthetic
Other Names:
|
|
Active Comparator: Adductor Canal Block - Injection -Site B
AC Block-Injection (lidocaine 2% and ropivacaine 1%) Site B - before the sartorius muscle crosses over the femoral artery
|
Local anesthetic
Other Names:
Local anesthetic
Other Names:
|
|
Active Comparator: Adductor Canal Block -Injection -Site C
AC Block-Injection (lidocaine 2% and ropivacaine 1%) Site C - as the sartorius muscle crosses over the femoral artery
|
Local anesthetic
Other Names:
Local anesthetic
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Cumulative 24 Hour Oral Morphine Equivalent Consumption
Time Frame: 24 hours
|
Post-Operative Analgesia
|
24 hours
|
|
Motor Power - Peak Force as measured by a dynamometer
Time Frame: 30 Minutes post Block
|
Percentage decrease in quadriceps motor strength at 30 minutes following adductor canal block compare to baseline
|
30 Minutes post Block
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Opioid Consumption
Time Frame: During surgical procedure
|
Intra-operative opioid consumption
|
During surgical procedure
|
|
Total opioids in Post Anesthetics (PAC)
Time Frame: Total length of time in PACU (total time in minutes from arrival in PACU to discharge to the Surgical Day Care is between 60-180 minutes
|
Cumulative oral morphine equivalent consumption in PACU
|
Total length of time in PACU (total time in minutes from arrival in PACU to discharge to the Surgical Day Care is between 60-180 minutes
|
|
Pain Scores - Questionnaire
Time Frame: 24 hours post block
|
Area under the curve for rest pain scores plotted against time during the first 24 hours
|
24 hours post block
|
|
Quality of Recovery (QoR-15)
Time Frame: 24 hours postoperatively
|
Quality of recovery measured using the QoR-15 at 24 hours postoperatively
|
24 hours postoperatively
|
|
Patient Satisfaction - Questionnaire
Time Frame: 24 hours postoperatively
|
Patient satisfaction with analgesia - NRS Pain Scale 0(no pain to 10(worst pain)
|
24 hours postoperatively
|
|
Hospital Discharge (Time to hospital discharge)
Time Frame: Same day as surgical procedure
|
Time to hospital discharge
|
Same day as surgical procedure
|
|
Nerve Block Complications
Time Frame: 24 hours postoperatively and 2 weeks postoperatively
|
Presence/absence of nerve block complications during the first 24 hours postoperatively and 2 weeks after surgery
|
24 hours postoperatively and 2 weeks postoperatively
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Richard Brull, MD, University of Toronto, Women's College Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Jaeger P, Nielsen ZJ, Henningsen MH, Hilsted KL, Mathiesen O, Dahl JB. Adductor canal block versus femoral nerve block and quadriceps strength: a randomized, double-blind, placebo-controlled, crossover study in healthy volunteers. Anesthesiology. 2013 Feb;118(2):409-15. doi: 10.1097/ALN.0b013e318279fa0b.
- Grevstad U, Mathiesen O, Valentiner LS, Jaeger P, Hilsted KL, Dahl JB. Effect of adductor canal block versus femoral nerve block on quadriceps strength, mobilization, and pain after total knee arthroplasty: a randomized, blinded study. Reg Anesth Pain Med. 2015 Jan-Feb;40(1):3-10. doi: 10.1097/AAP.0000000000000169.
- Hanson NA, Derby RE, Auyong DB, Salinas FV, Delucca C, Nagy R, Yu Z, Slee AE. Ultrasound-guided adductor canal block for arthroscopic medial meniscectomy: a randomized, double-blind trial. Can J Anaesth. 2013 Sep;60(9):874-80. doi: 10.1007/s12630-013-9992-9. Epub 2013 Jul 3.
- Jaeger P, Zaric D, Fomsgaard JS, Hilsted KL, Bjerregaard J, Gyrn J, Mathiesen O, Larsen TK, Dahl JB. Adductor canal block versus femoral nerve block for analgesia after total knee arthroplasty: a randomized, double-blind study. Reg Anesth Pain Med. 2013 Nov-Dec;38(6):526-32. doi: 10.1097/AAP.0000000000000015.
- Jenstrup MT, Jaeger P, Lund J, Fomsgaard JS, Bache S, Mathiesen O, Larsen TK, Dahl JB. Effects of adductor-canal-blockade on pain and ambulation after total knee arthroplasty: a randomized study. Acta Anaesthesiol Scand. 2012 Mar;56(3):357-64. doi: 10.1111/j.1399-6576.2011.02621.x. Epub 2012 Jan 4.
- Espelund M, Fomsgaard JS, Haraszuk J, Mathiesen O, Dahl JB. Analgesic efficacy of ultrasound-guided adductor canal blockade after arthroscopic anterior cruciate ligament reconstruction: a randomised controlled trial. Eur J Anaesthesiol. 2013 Jul;30(7):422-8. doi: 10.1097/EJA.0b013e328360bdb9.
- Andersen HL, Andersen SL, Tranum-Jensen J. The spread of injectate during saphenous nerve block at the adductor canal: a cadaver study. Acta Anaesthesiol Scand. 2015 Feb;59(2):238-45. doi: 10.1111/aas.12451. Epub 2014 Dec 14.
- Davis JJ, Bond TS, Swenson JD. Adductor canal block: more than just the saphenous nerve? Reg Anesth Pain Med. 2009 Nov-Dec;34(6):618-9. doi: 10.1097/AAP.0b013e3181bfbf00. No abstract available.
- Bendtsen TF, Moriggl B, Chan V, Pedersen EM, Borglum J. Redefining the adductor canal block. Reg Anesth Pain Med. 2014 Sep-Oct;39(5):442-3. doi: 10.1097/AAP.0000000000000119. No abstract available.
- Saranteas T, Anagnostis G, Paraskeuopoulos T, Koulalis D, Kokkalis Z, Nakou M, Anagnostopoulou S, Kostopanagiotou G. Anatomy and clinical implications of the ultrasound-guided subsartorial saphenous nerve block. Reg Anesth Pain Med. 2011 Jul-Aug;36(4):399-402. doi: 10.1097/AAP.0b013e318220f172.
- Kapoor R, Adhikary SD, Siefring C, McQuillan PM. The saphenous nerve and its relationship to the nerve to the vastus medialis in and around the adductor canal: an anatomical study. Acta Anaesthesiol Scand. 2012 Mar;56(3):365-7. doi: 10.1111/j.1399-6576.2011.02645.x.
- Manickam B, Perlas A, Duggan E, Brull R, Chan VW, Ramlogan R. Feasibility and efficacy of ultrasound-guided block of the saphenous nerve in the adductor canal. Reg Anesth Pain Med. 2009 Nov-Dec;34(6):578-80. doi: 10.1097/aap.0b013e3181bfbf84.
- Mariano ER, Perlas A. Adductor canal block for total knee arthroplasty: the perfect recipe or just one ingredient? Anesthesiology. 2014 Mar;120(3):530-2. doi: 10.1097/ALN.0000000000000121. No abstract available.
- Ilfeld BM, Hadzic A. Walking the tightrope after knee surgery: optimizing postoperative analgesia while minimizing quadriceps weakness. Anesthesiology. 2013 Feb;118(2):248-50. doi: 10.1097/ALN.0b013e318279fa3a. No abstract available.
- Krombach J, Gray AT. Sonography for saphenous nerve block near the adductor canal. Reg Anesth Pain Med. 2007 Jul-Aug;32(4):369-70. doi: 10.1016/j.rapm.2007.04.006. No abstract available. Erratum In: Reg Anesth Pain Med. 2007 Nov-Dec;32(6):536.
- Tsui BC, Ozelsel T. Ultrasound-guided transsartorial perifemoral artery approach for saphenous nerve block. Reg Anesth Pain Med. 2009 Mar-Apr;34(2):177-8; author reply 178. doi: 10.1097/AAP.0b013e31819a273e. No abstract available.
- Mariano ER, Kim TE, Wagner MJ, Funck N, Harrison TK, Walters T, Giori N, Woolson S, Ganaway T, Howard SK. A randomized comparison of proximal and distal ultrasound-guided adductor canal catheter insertion sites for knee arthroplasty. J Ultrasound Med. 2014 Sep;33(9):1653-62. doi: 10.7863/ultra.33.9.1653.
- Horn JL, Pitsch T, Salinas F, Benninger B. Anatomic basis to the ultrasound-guided approach for saphenous nerve blockade. Reg Anesth Pain Med. 2009 Sep-Oct;34(5):486-9. doi: 10.1097/AAP.0b013e3181ae11af.
- Chi J, Chiu B, Cao Y, Liu X, Wang J, Balu N, Yuan C, Xu J. Assessment of femoral artery atherosclerosis at the adductor canal using 3D black-blood MRI. Clin Radiol. 2013 Apr;68(4):e213-21. doi: 10.1016/j.crad.2012.12.002. Epub 2013 Jan 17.
- Head SJ, Leung RC, Hackman GP, Seib R, Rondi K, Schwarz SK. Ultrasound-guided saphenous nerve block--within versus distal to the adductor canal: a proof-of-principle randomized trial. Can J Anaesth. 2015 Jan;62(1):37-44. doi: 10.1007/s12630-014-0255-1. Epub 2014 Oct 22.
- Shah NA, Jain NP. Is continuous adductor canal block better than continuous femoral nerve block after total knee arthroplasty? Effect on ambulation ability, early functional recovery and pain control: a randomized controlled trial. J Arthroplasty. 2014 Nov;29(11):2224-9. doi: 10.1016/j.arth.2014.06.010. Epub 2014 Jun 19.
- Kirkpatrick JD, Sites BD, Antonakakis JG. Preliminary experience with a new approach to performing an ultrasound-guided saphenous nerve block in the mid to proximal femur. Reg Anesth Pain Med. 2010 Mar-Apr;35(2):222-3. doi: 10.1097/AAP.0b013e3181d24589. No abstract available.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 22, 2016
Primary Completion (Actual)
December 15, 2017
Study Completion (Actual)
January 2, 2018
Study Registration Dates
First Submitted
September 9, 2015
First Submitted That Met QC Criteria
September 17, 2015
First Posted (Estimate)
September 18, 2015
Study Record Updates
Last Update Posted (Actual)
February 27, 2019
Last Update Submitted That Met QC Criteria
February 25, 2019
Last Verified
February 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Arrhythmia Agents
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Sensory System Agents
- Anesthetics
- Membrane Transport Modulators
- Anesthetics, Local
- Voltage-Gated Sodium Channel Blockers
- Sodium Channel Blockers
- Lidocaine
- Ropivacaine
Other Study ID Numbers
- 2015-0046-B
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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