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ESP Volunteer LA Spread Controlled by MRI (ESP-MRI)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03751358
Recruitment Status : Terminated (Problem with MRI interpretation)
First Posted : November 23, 2018
Last Update Posted : May 20, 2020
Sponsor:
Information provided by (Responsible Party):
Vinmec Healthcare System

Brief Summary:

Background and Objectives: The Thoracic Erector Spinae Plane Blockade (ESPB) is a regional anesthesia technique recently described by Forero M in November 2016 , whereby local anesthetic (LA) is injected in the inter Fascial space between posteriorly the fascia of Erector Spinae Muscles (IFS-ESP) (the iliocostalis, longissimus, and spinalis muscles ) and anteriorly the inter-transverse ligament to achieve multi-metameric analgesia for thoracic or upper abdominal surgery.

Recent studies published showed controversies on the spread of the local anesthetic and also the clinical efficiency .

The clarification of mechanism of the paravertebral block is one example for the effectiveness of Magnetic Resonance imaging (MRI) in this context We therefore designed a prospective study in volunteers to examine the spread of LA via MRI investigation in correlation with the extent of somatic block after a standardized ultrasound (US) guided ESPB. Our study will study the spread at T4 or T5 level which is the level used for most of thoracic, cardiac and breast surgeries to determine if dye would spread anteriorly to the involve or igins of the ventral and dorsal branches of the spinal nerves.

Methods:

After ethical committee approval we will select 10 Healthy volunteers to perform Unilateral ESP single shot block with a very low dose of Local anesthetic (LA) (Ropivacaine 0.5% 1 mg/kg (Maximal dose recommended = 3 mg/kg ) mixed with 0,1ml gadolinium After injection an ultrasound image of the spread of the LA with an easy 3 Dimension will be acquired. 10 and 30 minutes after injection a MRI will be performed to analyze the ultrasound spread. An Evaluation of the extension of Sensory Blockade.

Patient will be kept under monitoring for 1,5 hours to assess any complication Sensory block will be assessed. At 1 week after the study day, all volunteers will undergo an investigation of the puncture sites to exclude puncture- related infection or hematoma.

Statistical analysis will be done The cranio-caudal spread of LA will be recorded (US + MRI) and described for each of the volunteers.


Condition or disease Intervention/treatment Phase
Regional Anesthesia Procedure: Unilateral Erector spinae plane block Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Healthy volunteers accepting to have a Unilateral ESP block with an MRI after injection of Low volume of local anesthetic
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Magnetic Resonance Imaging Analysis of the Spread of Local Anesthetic Solution After Ultrasound-guided Erector Spinae Plane Blockade
Actual Study Start Date : February 1, 2019
Actual Primary Completion Date : April 30, 2019
Actual Study Completion Date : June 30, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Unilateral Erector spinae plane block
Thoracic unilateral Erector spinae plane block performed on the volunteer and analyse of the spread of local anesthetic by magnetic resonance imaging
Procedure: Unilateral Erector spinae plane block
Magnetic résonance imaging
Other Name: Injection of Low volume of local anesthetic




Primary Outcome Measures :
  1. Magnetic resonnance Imaging spread [ Time Frame: 40 minutes after injection ]
    spread of the local anesthetic

  2. Sensory blockade evaluation [ Time Frame: 4 hours after local anesthetic injection ]
    Pinprick testing from cervical dermatomes to T12 dermatome



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy volunteers aged between 18 and 45 year old

Exclusion Criteria:

  • Refusal of the volunteer
  • Anatomical abnormalities of the thoracic spine identified by physical examination.
  • Body mass index ≥30 kg/m2
  • Medical contra-indication for Conscious MRI
  • Claustrophobia
  • Metal implants (pacemaker and others)
  • Known allergy or hypersensitivity against Ropivacaine or other amino-amide LAs
  • Participation in another clinical study within the last 4 weeks prior to study
  • Coagulopathies in the medical history
  • Abnormalities in electrocardiography that are considered clinically relevant such as atrio-ventricular block or bradycardia

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03751358


Locations
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Vietnam
VinMec INternational hospital
Hanoi, Vietnam, 100000
Sponsors and Collaborators
Vinmec Healthcare System
Investigators
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Study Chair: Huyen Vu Xuan, MD Vinmec Healthcare System
Publications:

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Responsible Party: Vinmec Healthcare System
ClinicalTrials.gov Identifier: NCT03751358    
Other Study ID Numbers: VINMECTC
First Posted: November 23, 2018    Key Record Dates
Last Update Posted: May 20, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Vinmec Healthcare System:
ESP Thoracic
Spread Local anesthetic
Volunteer
Magnetic résonance imaging
Additional relevant MeSH terms:
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Anesthetics
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents