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

Regional Anesthesia Clinical Trial

Official title:

Comparison of the Sensitive Cutaneous Block Distribution Following Femoral Nerve Block Using an Ultrasound Plus Neurostimulator Technique Versus an Approach Based on the Localization of the Femoral Artery.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02721290
• Other study ID #: 20160112
• Status: Recruiting
• Phase: N/A
• Start date: January 2016
• Est. completion date: December 2020

Study information

• Verified date: August 2019
• Source: Maisonneuve-Rosemont Hospital
• Contact: Issam Tanoubi, MD
• Phone: 1 844 634-3400
• Email: i.tanoubi[@]icloud.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: December 2020
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Femoral Nerve Block
• Hypersensitivity
• Regional Anesthesia

Intervention

Procedure:
• Femoral nerve block using Ultrasound and neurostimulator

• Femoral nerve block using Ultrasound

Drug:
• Ropivacaine 0.5%
Ropivacaine 0.5% (20cc total) will be injected for the performance of the block in the two arms of the study.

Locations

Country	Name	City	State
Canada	Hopital Maisonneuve-Rosemont	Montréal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Maisonneuve-Rosemont Hospital

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensitive cutaneous block distribution area for the two techniques	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.	45 minutes
Secondary	Time of block completion	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)	45 minutes
Secondary	Ease of ultrasound visualization of the femoral nerve	This will be assessed by the anesthesiologist making the femoral nerve block from a scale of 1 (no visualization) to 10 (excellent visualization).	45 minutes
Secondary	Ease of ultrasound visualization of the femoral artery	This will be assessed by the anesthesiologist making the femoral nerve block from a scale of 1 (no visualization) to 10 (excellent visualization).	45 minutes
Secondary	Numbers of needle redirection	The number of time for each patients using either techniques that the needle will have been withdrawn.	45 minutes
Secondary	Vascular puncture	Presence or absence of blood return at anytime in the tubing while performing the block.	45 minutes
Secondary	Paresthesia	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	45 minutes
Secondary	Patient Satisfaction	Satisfaction expressed by the patient after the completion of the femoral nerve block using a scale from 1 to 4.	45 minutes