Adductor Canal Block In Anterior Cruciate Ligament (ACL) Repair

Sponsor
University Health Network, Toronto (Other)
Overall Status
Completed
CT.gov ID
NCT01791036
Collaborator
(none)
100
1
2
22
4.5

Study Details

Study Description

Brief Summary

Adductor canal block will provide adequate analgesia to patients undergoing arthroscopic ACL reconstruction surgery, yet result in less motor blockade than a femoral block.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Adductor Canal Block
  • Procedure: Femoral Nerve Block
N/A

Detailed Description

This study is designed to demonstrate that postoperative analgesia produced by the adductor canal block is not inferior to that produced by femoral nerve block in patients undergoing arthroscopic ACL reconstruction surgery. The study will also compare the degree of motor blockade of the adductor canal block to that of the femoral nerve block.

Study Design

Study Type:
Interventional
Actual Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Postoperative Analgesia Produced by Adductor Canal (Distal Femoral Artery Compartment) Block Is Not Inferior to Femoral Nerve Block In Outpatient Arthroscopic Anterior Cruciate Ligament Repair
Study Start Date :
May 1, 2013
Actual Primary Completion Date :
Mar 1, 2015
Actual Study Completion Date :
Mar 1, 2015

Arms and Interventions

Arm Intervention/Treatment
Experimental: Adductor Canal Block Group

Adductor Canal Block

Procedure: Adductor Canal Block
Examination of the adductor canal using ultrasound will be performed using a high frequency linear probe. Following this the ultrasound probe will be positioned perpendicular to the skin in the medial upper-thigh region. The ultrasound probe will be moved either cephalad or caudad from its initial position in order to visualize the femoral artery immediately deep to the middle of the sartorius muscle. This point will then be selected as the appropriate level for needle insertion. Sham blocks using subcutaneous injection of normal saline will be used in both groups to maintain patient blinding.

Active Comparator: Femoral Nerve Block Group

Femoral Nerve Block

Procedure: Femoral Nerve Block
Examination of the femoral nerve using ultrasound will be performed using a high frequency linear probe. Following this the ultrasound probe will be positioned perpendicular to the skin at the level of the femoral crease. The femoral artery will be identified and the femoral nerve will then be located immediately lateral to the artery, deep to the fascia iliaca and superficial to the iliopsoas muscle. The needle will be positioned next to the femoral nerve. Following this 20 ml of 0.25% bupivacaine with epinephrine will be injected incrementally over a 1 to 2 minute period. Sham blocks using subcutaneous injection of normal saline will be used in both groups to maintain patient blinding.

Outcome Measures

Primary Outcome Measures

  1. Opioid consumption [24 hours]

    Postoperative cumulative opioid consumption during the first 24 hours. All doses of supplemental (PRN) oral and parenteral opioid analgesics required will be converted into equivalent doses of oral morphine

  2. Motor Blockade [30 minutes]

    The degree of motor blockade 30 minutes following the block procedure

  3. Pain Scores [12,24 and 48 hours]

    Visual Analog Pain scores at rest and with movement at admisssion and discharge from post-anesthesia care unit (PACU), AT DISCHARGE FROM same day surgery unit (SDC) and at 12, 24 and 48 hours

Secondary Outcome Measures

  1. Sensory blockade [30 min]

    The degree of sensory blockade 30 minutes following the block procedure

  2. Spread of local anesthetic [30 min]

    Spread of local anesthetic from the injection site

Other Outcome Measures

  1. Block procedure time [min]

    Block procedure time from probe placement on the skin to time of needle exit

  2. Block success [30 min]

    1 or 0 on both sensory and motor block testing after 30 min for success

Eligibility Criteria

Criteria

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

American Society of Anesthesiologists(ASA)classification I-III, Patients 18 to 50 years of age, BMI 18 - 40. Patients scheduled for anterior cruciate ligament reconstruction surgery under general anesthesia and nerve blocks.

Exclusion Criteria:

Refusal or inability to provide informed consent. Any contraindication to regional anesthesia including coagulopathy or bleeding diathesis, allergy to local anesthetics, infection, nerve injury or malignancy at the site of the block.

History of alcohol/drug dependence. History of long term opioid intake or chronic pain disorder. History of preexisting 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 the multimodal analgesic regimen.

Contacts and Locations

Locations

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

Sponsors and Collaborators

  • University Health Network, Toronto

Investigators

  • Principal Investigator: Vincent Chan, MD, University of Toronto
  • Principal Investigator: Richard Brull, MD, UHN - Women's College Hospital and Toronto Western Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT01791036
Other Study ID Numbers:
  • 12-5231-B
First Posted:
Feb 13, 2013
Last Update Posted:
Mar 4, 2015
Last Verified:
Mar 1, 2015
Keywords provided by University Health Network, Toronto

Study Results

No Results Posted as of Mar 4, 2015