Comparison of the Sensitive Cutaneous Block Distribution Following Femoral Nerve Block Using Two Femoral Block Techniques

Not Applicable

• Conditions: Femoral Nerve Block; Regional Anesthesia
• Interventions: Procedure: Femoral nerve block using Ultrasound and neurostimulator; Procedure: Femoral nerve block using Ultrasound; Drug: Ropivacaine 0.5%

• Registration Number: NCT02721290
• Lead Sponsor: Maisonneuve-Rosemont Hospital

Brief Summary

In this study, we will be comparing two approaches to the femoral block. The first or classical approach and one that is the most popular in our institution is used by combining ultrasound guidance and neurostimulator to do the block. The second is performed with the ultrasound alone aiming at the inferolateral aspect of the femoral artery with the needle and injecting. The primary endpoint of the study is the sensitive cutaneous block distribution using both techniques.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-01
• Study First Submitted: 2016-03-15
• Study First Submitted QC: 2016-03-22
• Study First Posted: 2016-03-29
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-29
• Last Update Posted: 2019-08-30
• Primary Completion: 2020-12
• Study Completion: 2020-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• Patients scheduled for an elective surgery for which the anesthesiologist planned to do a single shot or continuous femoral nerve block.

Exclusion Criteria

• Any contraindication to the femoral nerve block (coagulopathy, infection, pre-existing neuropathy, local anesthetic allergy and refusal of local anesthesia).
• Refusal to participate in the study
• Inability to understand or communicate the effect of local anesthesia secondary to the femoral nerve bloc.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Femoral nerve block using Ultrasound and neurostimulator	Ropivacaine 0.5%	Femoral block using the standard technique of ultrasound for femoral nerve identification and neurostimulator set at between 0.3-0.5 mA with quads muscle response for needle placement confirmation before injecting 20cc of Ropivacaine 0.5%.
Femoral nerve block using Ultrasound and neurostimulator	Femoral nerve block using Ultrasound and neurostimulator	Femoral block using the standard technique of ultrasound for femoral nerve identification and neurostimulator set at between 0.3-0.5 mA with quads muscle response for needle placement confirmation before injecting 20cc of Ropivacaine 0.5%.
Femoral nerve block using femoral artery target	Femoral nerve block using Ultrasound	Femoral block using the alternate technique of aiming for the inferolateral aspect of the femoral artery and injecting 20cc of Ropivacaine 0.5%.
Femoral nerve block using femoral artery target	Ropivacaine 0.5%	Femoral block using the alternate technique of aiming for the inferolateral aspect of the femoral artery and injecting 20cc of Ropivacaine 0.5%.

Primary Outcome Measures

Name	Time	Method
Sensitive cutaneous block distribution area for the two techniques	45 minutes	After performance of a femoral nerve block, ice will be applied on the skin to plot the anesthetized area at times 15, 30 and 45 mn. The sensation will be compared on a scale from 0 (no sensation) to 2 (no anesthesia) with the contralateral leg. An area in cm2 will be calculated for each of the patients and the two techniques will then be compared.

Secondary Outcome Measures

Name	Time	Method
Time of block completion	45 minutes	Time recorded from the end of the cutaneous local anesthetic injection to the end of the 20cc injection of the 0.5% Ropivacaine (time of block completion)
Ease of ultrasound visualization of the femoral artery	45 minutes	This will be assessed by the anesthesiologist making the femoral nerve block from a scale of 1 (no visualization) to 10 (excellent visualization).
Numbers of needle redirection	45 minutes	The number of time for each patients using either techniques that the needle will have been withdrawn.
Ease of ultrasound visualization of the femoral nerve	45 minutes	This will be assessed by the anesthesiologist making the femoral nerve block from a scale of 1 (no visualization) to 10 (excellent visualization).
Vascular puncture	45 minutes	Presence or absence of blood return at anytime in the tubing while performing the block.
Paresthesia	45 minutes	Presence or absence of the sensation of electrical shock felt by the patient in the territory of the femoral nerve at any point while performing the block
Patient Satisfaction	45 minutes	Satisfaction expressed by the patient after the completion of the femoral nerve block using a scale from 1 to 4.

Trial Locations

Locations (1)

Hopital Maisonneuve-Rosemont; 🇨🇦 Montréal, Quebec, Canada