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

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.

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.

Study Overview

• Status: Unknown
• Conditions: Regional Anesthesia; Femoral Nerve Block
• Intervention / Treatment: Procedure: Femoral nerve block using Ultrasound and neurostimulator; Drug: Ropivacaine 0.5%; Procedure: Femoral nerve block using Ultrasound

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Issam Tanoubi, MD; Phone Number: 3808 1 844 634-3400; Email: i.tanoubi@icloud.com
• Study Contact Backup: Name: Cédric Godbout-Simard, MD; Phone Number: 3808 1 844 634-3400; Email: cedric.godboutsimard@mail.mcgill.ca

Study Locations

• Canada
  • Quebec
    • Montréal, Quebec, Canada, H1T 2M4
      • Recruiting
      • Hopital Maisonneuve-Rosemont
      • Contact: Cédric Godbout-Simard, MD; Phone Number: 5147151723; Email: cedric.godboutsimard@mail.mcgill.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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%.	Procedure: Femoral nerve block using Ultrasound and neurostimulator; 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.
Experimental: Femoral nerve block using femoral artery target; Femoral block using the alternate technique of aiming for the inferolateral aspect of the femoral artery and injecting 20cc of Ropivacaine 0.5%.	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.; Procedure: Femoral nerve block using Ultrasound

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
Numbers of needle redirection	The number of time for each patients using either techniques that the needle will have been withdrawn.	45 minutes
Vascular puncture	Presence or absence of blood return at anytime in the tubing while performing the block.	45 minutes
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
Patient Satisfaction	Satisfaction expressed by the patient after the completion of the femoral nerve block using a scale from 1 to 4.	45 minutes

Collaborators and Investigators

• Sponsor: Maisonneuve-Rosemont Hospital

Study record dates

Study Major Dates

• Study Start: January 1, 2016
• Primary Completion (Anticipated): December 1, 2020
• Study Completion (Anticipated): December 1, 2020

Study Registration Dates

• First Submitted: March 15, 2016
• First Submitted That Met QC Criteria: March 22, 2016
• First Posted (Estimate): March 29, 2016

Study Record Updates

• Last Update Posted (Actual): August 30, 2019
• Last Update Submitted That Met QC Criteria: August 29, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Keywords: Knee surgery
• Additional Relevant MeSH Terms: Immune System Diseases; Hypersensitivity; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Ropivacaine
• Other Study ID Numbers: 20160112