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LILAC: Location of Injection of Local Anesthetics in the Adductor Canal Block

Sponsor
Women's College Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT02554864
Collaborator
(none)
108
Enrollment
1
Location
3
Arms
22.3
Actual Duration (Months)
4.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
108 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Location of Injection of Local Anesthetics in the Adductor Canal Block: A Randomized Controlled Trial of the Effect on Postoperative Analgesia and Motor Power
Actual Study Start Date :
Feb 22, 2016
Actual Primary Completion Date :
Dec 15, 2017
Actual Study Completion Date :
Jan 2, 2018

Arms and Interventions

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

Drug: lidocaine
Local anesthetic
Other Names:
  • Xylocaine

    • Drug: ropivacaine
    Local anesthetic
    Other Names:
  • Naropin

    		•
    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

    Drug: lidocaine
    Local anesthetic
    Other Names:
  • Xylocaine

    • Drug: ropivacaine
    Local anesthetic
    Other Names:
  • Naropin

    		•
    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

    Drug: lidocaine
    Local anesthetic
    Other Names:
  • Xylocaine

    • Drug: ropivacaine
    Local anesthetic
    Other Names:
  • Naropin

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Cumulative 24 Hour Oral Morphine Equivalent Consumption [24 hours]

      Post-Operative Analgesia

    2. Motor Power - Peak Force as measured by a dynamometer [30 Minutes post Block]

      Percentage decrease in quadriceps motor strength at 30 minutes following adductor canal block compare to baseline

    Secondary Outcome Measures

    1. Opioid Consumption [During surgical procedure]

      Intra-operative opioid consumption

    2. Total opioids in Post Anesthetics (PAC) [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

    3. Pain Scores - Questionnaire [24 hours post block]

      Area under the curve for rest pain scores plotted against time during the first 24 hours

    4. Quality of Recovery (QoR-15) [24 hours postoperatively]

      Quality of recovery measured using the QoR-15 at 24 hours postoperatively

    5. Patient Satisfaction - Questionnaire [24 hours postoperatively]

      Patient satisfaction with analgesia - NRS Pain Scale 0(no pain to 10(worst pain)

    6. Hospital Discharge (Time to hospital discharge) [Same day as surgical procedure]

      Time to hospital discharge

    7. Nerve Block Complications [24 hours postoperatively and 2 weeks postoperatively]

      Presence/absence of nerve block complications during the first 24 hours postoperatively and 2 weeks after surgery

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 50 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Women's College Hospital Toronto Ontario Canada M5S 1B2

    Sponsors and Collaborators

    • Women's College Hospital

    Investigators

    • Principal Investigator: Richard Brull, MD, University of Toronto, Women's College Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Women's College Hospital
    ClinicalTrials.gov Identifier:
    NCT02554864
    Other Study ID Numbers:
    • 2015-0046-B
    First Posted:
    Sep 18, 2015
    Last Update Posted:
    Feb 27, 2019
    Last Verified:
    Feb 1, 2019
    Additional relevant MeSH terms:
    Lidocaine
    Ropivacaine

    Study Results

    No Results Posted as of Feb 27, 2019