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

NCT ID: NCT00732706

Last Updated: 2008-08-12

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-08-31
• Study Completion Date: 2009-02-28

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.

Conditions

Femoral Nerve Disease

Keywords

FNB; Femoral Nerve; Sartorius Twitch; Quadriceps Twitch; Analgesia; Anesthesia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: TRIPLE

Study Groups

Sartorius Twitch

Femoral Nerve detection using Sartorius Twitch

Group Type: OTHER

Sartorius Muscle Twitch

Intervention Type: PROCEDURE

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

Group Type: OTHER

Quadriceps Muscle Twitch

Intervention Type: PROCEDURE

Stimulation of the femoral nerve branch responsible for activating the Quadriceps Muscle fascia with the lowest possible current.

Interventions

Sartorius Muscle Twitch

Stimulation of the femoral nerve branch responsible for activating the Sartorius Muscle fascia with the lowest possible current.

Intervention Type: PROCEDURE

Quadriceps Muscle Twitch

Stimulation of the femoral nerve branch responsible for activating the Quadriceps Muscle fascia with the lowest possible current.

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

The Physicians' Services Incorporated Foundation

OTHER

Sponsor Role: collaborator

Sunnybrook Health Sciences Centre

OTHER

Sponsor Role: lead

Responsible Party

Sunnybrook Health Sciences Centre

Principal Investigators

Imad Awad, MD

Role: PRINCIPAL_INVESTIGATOR

Sunnybrook Health Sciences Centre

Locations

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

Countries

Canada

Central Contacts

Imad Awad, MD

Role: CONTACT

Phone: 4164804864

Email: imad.awad@sunnybrook.ca

Facility Contacts

Imad Awad, MD

Role: primary

Other Identifiers

SHSCHOACFNB

Identifier Type: -

Identifier Source: org_study_id