Trial record 3 of 89 for:    Open Studies | root canal

Adductor Canal Block In Anterior Cruciate Ligament (ACL) Repair

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2013 by University Health Network, Toronto
Sponsor:
Information provided by (Responsible Party):
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT01791036
First received: February 11, 2013
Last updated: July 9, 2014
Last verified: February 2013
  Purpose

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 Intervention
Neuromuscular Block
Procedure: Adductor Canal Block
Procedure: Femoral Nerve Block

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Further study details as provided by University Health Network, Toronto:

Primary Outcome Measures:
  • Opioid consumption [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    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


Secondary Outcome Measures:
  • Motor blockade [ Time Frame: 30 min ] [ Designated as safety issue: No ]
    The degree of motor blockade 30 minutes following the block procedure

  • Sensory blockade [ Time Frame: 30 min ] [ Designated as safety issue: No ]
    The degree of sensory blockade 30 minutes following the block procedure

  • Spread of local anesthetic [ Time Frame: 30 min ] [ Designated as safety issue: No ]
    Spread of local anesthetic from the injection site

  • Pain scores [ Time Frame: 12, 24 and 48 hours ] [ Designated as safety issue: No ]
    Visual Analogue Pain scores at rest and with movement at admission and discharge from post-anesthesia care unit (PACU), at discharge from same day surgery, and at 12, 24 and 48 hours


Other Outcome Measures:
  • Block procedure time [ Time Frame: min ] [ Designated as safety issue: No ]
    Block procedure time from probe placement on the skin to time of needle exit

  • Block success [ Time Frame: 30 min ] [ Designated as safety issue: No ]
    1 or 0 on both sensory and motor block testing after 30 min for success


Estimated Enrollment: 180
Study Start Date: May 2013
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01791036

Contacts
Contact: Richard Brull, MD 416-715-6657 richard.brull@uhn.ca
Contact: Vincent Chan, MD 416-790-6440 vincent.chan@uhn.ca

Locations
Canada, Ontario
Women's College Hospital Recruiting
Toronto, Ontario, Canada, M5S 1B2
Contact: Stephanie Oldfield    416-323 6008    stephanie.oldfield@wchospital.ca   
Sub-Investigator: Vincent WS Chan, MD         
Principal Investigator: Richard Brull, MD         
Sponsors and Collaborators
University Health Network, Toronto
Investigators
Principal Investigator: Vincent Chan, MD University of Toronto
Principal Investigator: Richard Brull, MD UHN - Wpmen's College Hospital and Toronto Western Hospital