Femoral Nerve Block: Anatomical Insertion Point - A Prospective Randomised Double-Blind Controlled Trial (FNB)
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|ClinicalTrials.gov Identifier: NCT00732706|
Recruitment Status : Unknown
Verified August 2008 by Sunnybrook Health Sciences Centre.
Recruitment status was: Not yet recruiting
First Posted : August 12, 2008
Last Update Posted : August 12, 2008
|Condition or disease||Intervention/treatment||Phase|
|Femoral Nerve Disease||Procedure: Sartorius Muscle Twitch Procedure: Quadriceps Muscle Twitch||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||Femoral Nerve Block: Anatomical Insertion Point - A Prospective Randomised Double-Blind Controlled Trial|
|Study Start Date :||August 2008|
|Estimated Primary Completion Date :||February 2009|
|Estimated Study Completion Date :||February 2009|
Femoral Nerve detection using Sartorius Twitch
Procedure: Sartorius Muscle Twitch
Stimulation of the femoral nerve branch responsible for activating the Sartorius Muscle fascia with the lowest possible current.
Femoral Nerve detection using Quadriceps Twitch
Procedure: Quadriceps Muscle Twitch
Stimulation of the femoral nerve branch responsible for activating the Quadriceps Muscle fascia with the lowest possible current.
- Comparing success of femoral never block (motor and sensory) using sartorius twitch versus quadriceps femoris twitch as an end point, using Motor and Sensory Scores. [ Time Frame: 30 minutes ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00732706
|Contact: Imad Awad, MDemail@example.com|
|Sunnybrook Health Sciences Centre||Not yet recruiting|
|Toronto, Ontario, Canada, M4Y 1H1|
|Contact: Imad Awad, MD 4164804864 firstname.lastname@example.org|
|Sub-Investigator: Jonathan Anns, MBChB|
|Principal Investigator:||Imad Awad, MD||Sunnybrook Health Sciences Centre|