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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02721290
Other study ID # 20160112
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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