- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01791036
Adductor Canal Block In Anterior Cruciate Ligament (ACL) Repair
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 Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Ontario
-
Toronto, Ontario, Canada, M5S 1B2
- Women's College Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
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 |
|---|---|
|
Experimental: Adductor Canal Block Group
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
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Opioid consumption
Time Frame: 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
|
24 hours
|
|
Motor Blockade
Time Frame: 30 minutes
|
The degree of motor blockade 30 minutes following the block procedure
|
30 minutes
|
|
Pain Scores
Time Frame: 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
|
12,24 and 48 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Sensory blockade
Time Frame: 30 min
|
The degree of sensory blockade 30 minutes following the block procedure
|
30 min
|
|
Spread of local anesthetic
Time Frame: 30 min
|
Spread of local anesthetic from the injection site
|
30 min
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Block procedure time
Time Frame: min
|
Block procedure time from probe placement on the skin to time of needle exit
|
min
|
|
Block success
Time Frame: 30 min
|
1 or 0 on both sensory and motor block testing after 30 min for success
|
30 min
|
Collaborators and Investigators
Investigators
- Principal Investigator: Vincent Chan, MD, University of Toronto
- Principal Investigator: Richard Brull, MD, UHN - Women's College Hospital and Toronto Western Hospital
Publications and helpful links
General Publications
- Williams BA, Kentor ML, Vogt MT, Irrgang JJ, Bottegal MT, West RV, Harner CD, Fu FH, Williams JP. Reduction of verbal pain scores after anterior cruciate ligament reconstruction with 2-day continuous femoral nerve block: a randomized clinical trial. Anesthesiology. 2006 Feb;104(2):315-27. doi: 10.1097/00000542-200602000-00018.
- Dauri M, Fabbi E, Mariani P, Faria S, Carpenedo R, Sidiropoulou T, Coniglione F, Silvi MB, Sabato AF. Continuous femoral nerve block provides superior analgesia compared with continuous intra-articular and wound infusion after anterior cruciate ligament reconstruction. Reg Anesth Pain Med. 2009 Mar-Apr;34(2):95-9. doi: 10.1097/AAP.0b013e31819baf98.
- Sakura S, Hara K, Ota J, Tadenuma S. Ultrasound-guided peripheral nerve blocks for anterior cruciate ligament reconstruction: effect of obturator nerve block during and after surgery. J Anesth. 2010 Jun;24(3):411-7. doi: 10.1007/s00540-010-0916-3. Epub 2010 Mar 12.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 12-5231-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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