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
1 other identifier
interventional
100
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started May 2013
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 11, 2013
CompletedFirst Posted
Study publicly available on registry
February 13, 2013
CompletedStudy Start
First participant enrolled
May 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2015
CompletedMarch 4, 2015
March 1, 2015
1.8 years
February 11, 2013
March 2, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Opioid consumption
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
The degree of motor blockade 30 minutes following the block procedure
30 minutes
Pain Scores
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 Outcomes (2)
Sensory blockade
30 min
Spread of local anesthetic
30 min
Other Outcomes (2)
Block procedure time
min
Block success
30 min
Study Arms (2)
Adductor Canal Block Group
EXPERIMENTALAdductor Canal Block
Femoral Nerve Block Group
ACTIVE COMPARATORFemoral Nerve Block
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Women's College Hospital
Toronto, Ontario, M5S 1B2, Canada
Related Publications (3)
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.
PMID: 16436852BACKGROUNDDauri 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.
PMID: 19282706BACKGROUNDSakura 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.
PMID: 20225073BACKGROUND
Study Officials
- PRINCIPAL INVESTIGATOR
Vincent Chan, MD
University of Toronto
- PRINCIPAL INVESTIGATOR
Richard Brull, MD
UHN - Women's College Hospital and Toronto Western Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 11, 2013
First Posted
February 13, 2013
Study Start
May 1, 2013
Primary Completion
March 1, 2015
Study Completion
March 1, 2015
Last Updated
March 4, 2015
Record last verified: 2015-03