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Sponsors and Collaborators: |
Sunnybrook Health Sciences Centre The Physicians' Services Incorporated Foundation |
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Information provided by: | Sunnybrook Health Sciences Centre |
ClinicalTrials.gov Identifier: | NCT00732706 |
Nerve blocks are an effective way to control pain after surgery. There are two major nerves that provide sensation to the knee: the femoral nerve provides sensation to the front of the knee and sciatic nerve provides sensation to the back of the knee. The femoral nerve has two branches. To locate the nerve, we use a machine called (Nerve stimulator) which is attached to the needle used for nerve block. Use of a nerve stimulator is standard practice for this procedure. Ultrasound is being increasingly used to locate nerves but is not used universally. We will use the nerve stimulator and ultrasound to locate the femoral nerve but patients will randomly be selected to enter a group looking at the stimulation of one or the other branches of the femoral nerve. The two branches when stimulated produce different muscle contractions in the thigh. We do not know from research which is the optimal contraction to position the needle to get the best block. After the knee replacement patients will still have the same analgesic medication available as patients would have received if they were not in the study.
Condition | Intervention |
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Femoral Nerve Disease |
Procedure: Sartorius Muscle Twitch Procedure: Quadriceps Muscle Twitch |
Study Type: | Interventional |
Study Design: | Diagnostic, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study |
Official Title: | Femoral Nerve Block: Anatomical Insertion Point - A Prospective Randomised Double-Blind Controlled Trial |
Estimated Enrollment: | 60 |
Study Start Date: | August 2008 |
Estimated Study Completion Date: | February 2009 |
Estimated Primary Completion Date: | February 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Sartorius Twitch
Femoral Nerve detection using Sartorius Twitch
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Procedure: Sartorius Muscle Twitch
Stimulation of the femoral nerve branch responsible for activating the Sartorius Muscle fascia with the lowest possible current.
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Quadriceps Twitch
Femoral Nerve detection using Quadriceps Twitch
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Procedure: Quadriceps Muscle Twitch
Stimulation of the femoral nerve branch responsible for activating the Quadriceps Muscle fascia with the lowest possible current.
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To determine if needle insertion at the inguinal crease with stimulation of sartorius muscle (anterior branch) causes an equivalent block to the classical method with stimulation of the quadriceps femoris muscle (posterior branch), for femoral nerve blockade. To test this hypothesis, we plan to conduct a randomised controlled double-blind study comparing success of femoral never block (motor and sensory) using sartorius twitch versus quadriceps femoris twitch as an end point. We will also evaluate the local anesthetic distribution under the facia iliaca sheath using ultrasound imaging.
Methods: Following institutional ethical approval and obtaining written informed consent, we plan to recruit 60 patients aged 18-80, ASA I-III scheduled to undergo unilateral total knee arthroplastly in this prospective, randomised, double blinded controlled trial.
Ages Eligible for Study: | 18 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Imad Awad, MD | 4164804864 | imad.awad@sunnybrook.ca |
Canada, Ontario | |
Sunnybrook Health Sciences Centre | |
Toronto, Ontario, Canada, M4Y 1H1 |
Principal Investigator: | Imad Awad, MD | Sunnybrook Health Sciences Centre |
Responsible Party: | Sunnybrook Health Sciences Centre ( Dr. Imad Awad ) |
Study ID Numbers: | SHSCHOACFNB |
Study First Received: | August 8, 2008 |
Last Updated: | August 11, 2008 |
ClinicalTrials.gov Identifier: | NCT00732706 History of Changes |
Health Authority: | Canada: Health Canada |
FNB Femoral Nerve Sartorius Twitch |
Quadriceps Twitch Analgesia Anesthesia |
Neuromuscular Diseases Femoral Neuropathy Peripheral Nervous System Diseases Anesthetics Mononeuropathies |
Neuromuscular Diseases Femoral Neuropathy Peripheral Nervous System Diseases Nervous System Diseases Mononeuropathies |