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

Primary Purpose

Regional Anesthesia, Femoral Nerve Block

Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Femoral nerve block using Ultrasound and neurostimulator
Femoral nerve block using Ultrasound
Ropivacaine 0.5%
Sponsored by
Maisonneuve-Rosemont Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Regional Anesthesia focused on measuring Knee surgery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hopital Maisonneuve-RosemontRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Femoral nerve block using Ultrasound and neurostimulator

Femoral nerve block using femoral artery target

Arm Description

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 block using the alternate technique of aiming for the inferolateral aspect of the femoral artery and injecting 20cc of Ropivacaine 0.5%.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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The number of time for each patients using either techniques that the needle will have been withdrawn.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

Full Information

First Posted
March 15, 2016
Last Updated
August 29, 2019
Sponsor
Maisonneuve-Rosemont Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02721290
Brief Title
Comparison of the Sensitive Cutaneous Block Distribution Following Femoral Nerve Block Using Two Femoral Block Techniques
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.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Unknown status
Study Start Date
January 2016 (undefined)
Primary Completion Date
December 2020 (Anticipated)
Study Completion Date
December 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Maisonneuve-Rosemont Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Regional Anesthesia, Femoral Nerve Block
Keywords
Knee surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Femoral nerve block using Ultrasound and neurostimulator
Arm Type
Active Comparator
Arm Description
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%.
Arm Title
Femoral nerve block using femoral artery target
Arm Type
Experimental
Arm Description
Femoral block using the alternate technique of aiming for the inferolateral aspect of the femoral artery and injecting 20cc of Ropivacaine 0.5%.
Intervention Type
Procedure
Intervention Name(s)
Femoral nerve block using Ultrasound and neurostimulator
Intervention Type
Procedure
Intervention Name(s)
Femoral nerve block using Ultrasound
Intervention Type
Drug
Intervention Name(s)
Ropivacaine 0.5%
Intervention Description
Ropivacaine 0.5% (20cc total) will be injected for the performance of the block in the two arms of the study.
Primary Outcome Measure Information:
Title
Sensitive cutaneous block distribution area for the two techniques
Description
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.
Time Frame
45 minutes
Secondary Outcome Measure Information:
Title
Time of block completion
Description
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)
Time Frame
45 minutes
Title
Ease of ultrasound visualization of the femoral nerve
Description
This will be assessed by the anesthesiologist making the femoral nerve block from a scale of 1 (no visualization) to 10 (excellent visualization).
Time Frame
45 minutes
Title
Ease of ultrasound visualization of the femoral artery
Description
This will be assessed by the anesthesiologist making the femoral nerve block from a scale of 1 (no visualization) to 10 (excellent visualization).
Time Frame
45 minutes
Title
Numbers of needle redirection
Description
The number of time for each patients using either techniques that the needle will have been withdrawn.
Time Frame
45 minutes
Title
Vascular puncture
Description
Presence or absence of blood return at anytime in the tubing while performing the block.
Time Frame
45 minutes
Title
Paresthesia
Description
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
Time Frame
45 minutes
Title
Patient Satisfaction
Description
Satisfaction expressed by the patient after the completion of the femoral nerve block using a scale from 1 to 4.
Time Frame
45 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Issam Tanoubi, MD
Phone
1 844 634-3400
Ext
3808
Email
i.tanoubi@icloud.com
First Name & Middle Initial & Last Name or Official Title & Degree
Cédric Godbout-Simard, MD
Phone
1 844 634-3400
Ext
3808
Email
cedric.godboutsimard@mail.mcgill.ca
Facility Information:
Facility Name
Hopital Maisonneuve-Rosemont
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H1T 2M4
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cédric Godbout-Simard, MD
Phone
5147151723
Email
cedric.godboutsimard@mail.mcgill.ca

12. IPD Sharing Statement

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

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