Femoral Nerve Block: Anatomical Insertion Point - A Prospective Randomised Double-Blind Controlled Trial (FNB)
Primary Purpose
Femoral Nerve Disease
Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Sartorius Muscle Twitch
Quadriceps Muscle Twitch
Sponsored by
About this trial
This is an interventional diagnostic trial for Femoral Nerve Disease focused on measuring FNB, Femoral Nerve, Sartorius Twitch, Quadriceps Twitch, Analgesia, Anesthesia
Eligibility 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.
Sites / Locations
- Sunnybrook Health Sciences Centre
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Sartorius Twitch
Quadriceps Twitch
Arm Description
Femoral Nerve detection using Sartorius Twitch
Femoral Nerve detection using Quadriceps Twitch
Outcomes
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT00732706
First Posted
August 8, 2008
Last Updated
August 11, 2008
Sponsor
Sunnybrook Health Sciences Centre
Collaborators
The Physicians' Services Incorporated Foundation
1. Study Identification
Unique Protocol Identification Number
NCT00732706
Brief Title
Femoral Nerve Block: Anatomical Insertion Point - A Prospective Randomised Double-Blind Controlled Trial
Acronym
FNB
Official Title
Femoral Nerve Block: Anatomical Insertion Point - A Prospective Randomised Double-Blind Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
August 2008
Overall Recruitment Status
Unknown status
Study Start Date
August 2008 (undefined)
Primary Completion Date
February 2009 (Anticipated)
Study Completion Date
February 2009 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Sunnybrook Health Sciences Centre
Collaborators
The Physicians' Services Incorporated Foundation
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Femoral Nerve Disease
Keywords
FNB, Femoral Nerve, Sartorius Twitch, Quadriceps Twitch, Analgesia, Anesthesia
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Sartorius Twitch
Arm Type
Other
Arm Description
Femoral Nerve detection using Sartorius Twitch
Arm Title
Quadriceps Twitch
Arm Type
Other
Arm Description
Femoral Nerve detection using Quadriceps Twitch
Intervention Type
Procedure
Intervention Name(s)
Sartorius Muscle Twitch
Intervention Description
Stimulation of the femoral nerve branch responsible for activating the Sartorius Muscle fascia with the lowest possible current.
Intervention Type
Procedure
Intervention Name(s)
Quadriceps Muscle Twitch
Intervention Description
Stimulation of the femoral nerve branch responsible for activating the Quadriceps Muscle fascia with the lowest possible current.
Primary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Imad Awad, MD
Phone
4164804864
Email
imad.awad@sunnybrook.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Imad Awad, MD
Organizational Affiliation
Sunnybrook Health Sciences Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sunnybrook Health Sciences Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4Y 1H1
Country
Canada
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Imad Awad, MD
Phone
4164804864
Email
imad.awad@sunnybrook.ca
First Name & Middle Initial & Last Name & Degree
Jonathan Anns, MBChB
12. IPD Sharing Statement
Learn more about this trial
Femoral Nerve Block: Anatomical Insertion Point - A Prospective Randomised Double-Blind Controlled Trial
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