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

NCT02721290 | Unknown

• 1 other identifier: 20160112
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Regional Anesthesia; Femoral Nerve Block

Keywords

Knee surgery

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Time of block completion

  45 minutes

• Ease of ultrasound visualization of the femoral nerve

  45 minutes

• Ease of ultrasound visualization of the femoral artery

  45 minutes

• Numbers of needle redirection

  45 minutes

• Vascular puncture

  45 minutes

Study Arms (2)

Femoral nerve block using Ultrasound and neurostimulator

ACTIVE COMPARATOR

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%

Femoral nerve block using femoral artery target

EXPERIMENTAL

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

Procedure: Femoral nerve block using Ultrasound; Drug: Ropivacaine 0.5%

Interventions

Femoral nerve block using Ultrasound and neurostimulator PROCEDURE

Femoral nerve block using Ultrasound and neurostimulator

Femoral nerve block using Ultrasound PROCEDURE

Femoral nerve block using femoral artery target

Ropivacaine 0.5% DRUG

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

Femoral nerve block using Ultrasound and neurostimulator; Femoral nerve block using femoral artery target

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Maisonneuve-Rosemont Hospital: lead

Study Sites (1)

Hopital Maisonneuve-Rosemont

Montreal, Quebec, H1T 2M4, Canada

RECRUITING

Central Study Contacts

Issam Tanoubi, MD

CONTACT

1 844 634-3400; i.tanoubi@icloud.com

Cédric Godbout-Simard, MD

CONTACT

1 844 634-3400; cedric.godboutsimard@mail.mcgill.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: March 15, 2016
• First Posted: March 29, 2016
• Study Start: January 1, 2016
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2020
• Last Updated: August 30, 2019

Record last verified: 2019-08

Locations

CA (1)