ESP Volunteer LA Spread Controlled by MRI (ESP-MRI)
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|ClinicalTrials.gov Identifier: NCT03751358|
Recruitment Status : Terminated (Problem with MRI interpretation)
First Posted : November 23, 2018
Last Update Posted : May 20, 2020
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.
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|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||8 participants|
|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)|
|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|
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
- Magnetic resonnance Imaging spread [ Time Frame: 40 minutes after injection ]spread of the local anesthetic
- Sensory blockade evaluation [ Time Frame: 4 hours after local anesthetic injection ]Pinprick testing from cervical dermatomes to T12 dermatome
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
|VinMec INternational hospital|
|Hanoi, Vietnam, 100000|
|Study Chair:||Huyen Vu Xuan, MD||Vinmec Healthcare System|