ESP Volunteer LA Spread Controlled by MRI

NCT03751358 | Terminated DMC

• 1 other identifier: VINMECTC
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Regional Anesthesia

Keywords

ESP Thoracic; Spread Local anesthetic; Volunteer; Magnetic résonance imaging

Outcome Measures

Primary Outcomes (2)

• Magnetic resonnance Imaging spread

  spread of the local anesthetic

  40 minutes after injection

• Sensory blockade evaluation

  Pinprick testing from cervical dermatomes to T12 dermatome

  4 hours after local anesthetic injection

Study Arms (1)

Unilateral Erector spinae plane block

EXPERIMENTAL

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

Interventions

Unilateral Erector spinae plane block PROCEDURE

Magnetic résonance imaging

Also known as: Injection of Low volume of local anesthetic

Unilateral Erector spinae plane block

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy volunteers aged between 18 and 45 year old

You may not qualify if:

• 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

Sponsors & Collaborators

• Vinmec Healthcare System: lead

Study Sites (1)

VinMec INternational hospital

Hanoi, 100000, Vietnam

Location

Related Publications (9)

• Forero M, Adhikary SD, Lopez H, Tsui C, Chin KJ. The Erector Spinae Plane Block: A Novel Analgesic Technique in Thoracic Neuropathic Pain. Reg Anesth Pain Med. 2016 Sep-Oct;41(5):621-7. doi: 10.1097/AAP.0000000000000451.

  PMID: 27501016 BACKGROUND

• Ivanusic J, Konishi Y, Barrington MJ. A Cadaveric Study Investigating the Mechanism of Action of Erector Spinae Blockade. Reg Anesth Pain Med. 2018 Aug;43(6):567-571. doi: 10.1097/AAP.0000000000000789.

  PMID: 29746445 BACKGROUND

• Taketa Y, Irisawa Y, Fujitani T. Ultrasound-guided erector spinae plane block elicits sensory loss around the lateral, but not the parasternal, portion of the thorax. J Clin Anesth. 2018 Jun;47:84-85. doi: 10.1016/j.jclinane.2018.03.023. Epub 2018 Apr 6. No abstract available.

  PMID: 29631112 BACKGROUND

• Schwartzmann A, Peng P, Maciel MA, Forero M. Mechanism of the erector spinae plane block: insights from a magnetic resonance imaging study. Can J Anaesth. 2018 Oct;65(10):1165-1166. doi: 10.1007/s12630-018-1187-y. Epub 2018 Aug 3. No abstract available.

  PMID: 30076575 BACKGROUND

• Marhofer D, Marhofer P, Kettner SC, Fleischmann E, Prayer D, Schernthaner M, Lackner E, Willschke H, Schwetz P, Zeitlinger M. Magnetic resonance imaging analysis of the spread of local anesthetic solution after ultrasound-guided lateral thoracic paravertebral blockade: a volunteer study. Anesthesiology. 2013 May;118(5):1106-12. doi: 10.1097/ALN.0b013e318289465f.

  PMID: 23442752 BACKGROUND

• Andreae MH, Andreae DA. Regional anaesthesia to prevent chronic pain after surgery: a Cochrane systematic review and meta-analysis. Br J Anaesth. 2013 Nov;111(5):711-20. doi: 10.1093/bja/aet213. Epub 2013 Jun 28.

  PMID: 23811426 BACKGROUND

• Perkins FM, Kehlet H. Chronic pain as an outcome of surgery. A review of predictive factors. Anesthesiology. 2000 Oct;93(4):1123-33. doi: 10.1097/00000542-200010000-00038. No abstract available.

  PMID: 11020770 BACKGROUND

• Fletcher D, Martinez V. Opioid-induced hyperalgesia in patients after surgery: a systematic review and a meta-analysis. Br J Anaesth. 2014 Jun;112(6):991-1004. doi: 10.1093/bja/aeu137.

  PMID: 24829420 BACKGROUND

• Gan TJ, Robinson SB, Oderda GM, Scranton R, Pepin J, Ramamoorthy S. Impact of postsurgical opioid use and ileus on economic outcomes in gastrointestinal surgeries. Curr Med Res Opin. 2015 Apr;31(4):677-86. doi: 10.1185/03007995.2015.1005833. Epub 2015 Feb 10.

  PMID: 25586296 BACKGROUND

Study Officials

• Huyen Vu Xuan, MD

  Vinmec Healthcare System

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Healthy volunteers accepting to have a Unilateral ESP block with an MRI after injection of Low volume of local anesthetic

Study Record Dates

• First Submitted: November 19, 2018
• First Posted: November 23, 2018
• Study Start: February 1, 2019
• Primary Completion: April 30, 2019
• Study Completion: June 30, 2019
• Last Updated: May 20, 2020

Record last verified: 2020-05

Locations

VN (1)