Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2008 by Sunnybrook Health Sciences Centre.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
The Physicians' Services Incorporated Foundation
Information provided by:
Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier:
NCT00732706
First received: August 8, 2008
Last updated: August 11, 2008
Last verified: August 2008

August 8, 2008
August 11, 2008
August 2008
February 2009   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00732706 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Femoral Nerve Block: Anatomical Insertion Point - A Prospective Randomised Double-Blind Controlled Trial
Femoral Nerve Block: Anatomical Insertion Point - A Prospective Randomised Double-Blind Controlled Trial

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Diagnostic
Femoral Nerve Disease
  • Procedure: Sartorius Muscle Twitch
    Stimulation of the femoral nerve branch responsible for activating the Sartorius Muscle fascia with the lowest possible current.
  • Procedure: Quadriceps Muscle Twitch
    Stimulation of the femoral nerve branch responsible for activating the Quadriceps Muscle fascia with the lowest possible current.
  • Sartorius Twitch
    Femoral Nerve detection using Sartorius Twitch
    Intervention: Procedure: Sartorius Muscle Twitch
  • Quadriceps Twitch
    Femoral Nerve detection using Quadriceps Twitch
    Intervention: Procedure: Quadriceps Muscle Twitch
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
60
February 2009
February 2009   (final data collection date for primary outcome measure)

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.
Both
18 Years to 80 Years
Yes
Contact: Imad Awad, MD 4164804864 imad.awad@sunnybrook.ca
Canada
 
NCT00732706
SHSCHOACFNB
No
Dr. Imad Awad, Sunnybrook Health Sciences Centre
Sunnybrook Health Sciences Centre
The Physicians' Services Incorporated Foundation
Principal Investigator: Imad Awad, MD Sunnybrook Health Sciences Centre
Sunnybrook Health Sciences Centre
August 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP