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Femoral Nerve Block: Anatomical Insertion Point - A Prospective Randomised Double-Blind Controlled Trial (FNB)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified August 2008 by Sunnybrook Health Sciences Centre.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00732706
First Posted: August 12, 2008
Last Update Posted: August 12, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
The Physicians' Services Incorporated Foundation
Information provided by:
Sunnybrook Health Sciences Centre
  Purpose
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
Femoral Nerve Disease Procedure: Sartorius Muscle Twitch Procedure: Quadriceps Muscle Twitch

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Femoral Nerve Block: Anatomical Insertion Point - A Prospective Randomised Double-Blind Controlled Trial

Further study details as provided by Sunnybrook Health Sciences Centre:

Primary Outcome Measures:
  • 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 ]

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
Sartorius Twitch
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.
Quadriceps Twitch
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.

Detailed Description:

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Patients aged 18-80
  • ASA Status I-III
  • Unilateral total knee arthroplasty Patients

Exclusion Criteria:

  • Patients with a history of significant medical or psychiatric problems
  • Patients with BMI > 35
  • Unable to cooperate with the study protocol or unable to understand English
  • Had allergy to local anaesthetics or fentanyl
  • Prior surgery in the inguinal region
  • Sensory or motor disease
  • Diabetic neuropathy.
  Contacts and Locations
Information from the National Library of Medicine

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


Contacts
Contact: Imad Awad, MD 4164804864 imad.awad@sunnybrook.ca

Locations
Canada, Ontario
Sunnybrook Health Sciences Centre Not yet recruiting
Toronto, Ontario, Canada, M4Y 1H1
Contact: Imad Awad, MD    4164804864    imad.awad@sunnybrook.ca   
Sub-Investigator: Jonathan Anns, MBChB         
Sponsors and Collaborators
Sunnybrook Health Sciences Centre
The Physicians' Services Incorporated Foundation
Investigators
Principal Investigator: Imad Awad, MD Sunnybrook Health Sciences Centre
  More Information

Responsible Party: Dr. Imad Awad, Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier: NCT00732706     History of Changes
Other Study ID Numbers: SHSCHOACFNB
First Submitted: August 8, 2008
First Posted: August 12, 2008
Last Update Posted: August 12, 2008
Last Verified: August 2008

Keywords provided by Sunnybrook Health Sciences Centre:
FNB
Femoral Nerve
Sartorius Twitch
Quadriceps Twitch
Analgesia
Anesthesia

Additional relevant MeSH terms:
Nervous System Diseases
Femoral Neuropathy
Mononeuropathies
Peripheral Nervous System Diseases
Neuromuscular Diseases