Adductor Canal Block In Anterior Cruciate Ligament (ACL) Repair

Neuromuscular Block Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01791036
• Other study ID #: 12-5231-B
• Status: Completed
• Phase: N/A
• First received: February 11, 2013
• Last updated: March 2, 2015
• Start date: May 2013
• Est. completion date: March 2015

Study information

• Verified date: March 2015
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Neuromuscular Block

Intervention

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.
• 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.

Locations

Country	Name	City	State
Canada	Women's College Hospital	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Block procedure time	Block procedure time from probe placement on the skin to time of needle exit	min	No
Other	Block success	1 or 0 on both sensory and motor block testing after 30 min for success	30 min	No
Primary	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	No
Primary	Motor Blockade	The degree of motor blockade 30 minutes following the block procedure	30 minutes	No
Primary	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	No
Secondary	Sensory blockade	The degree of sensory blockade 30 minutes following the block procedure	30 min	No
Secondary	Spread of local anesthetic	Spread of local anesthetic from the injection site	30 min	No