Dispersion of Local Anesthetic on the Erector Spinae Plane Block in Cadavers

May 22, 2018 updated by: Marcelo Vaz Perez, Federal University of São Paulo

Determination of Relationship Between Volume and Dispersion of Local Anesthetic on Ultrasound-guided Erector Spinae Plane Block in Cadavers

This study aims to better understand the dispersion of local anesthetic on the Erector Spinae Block, a new technique developed for analgesia. It consists on injection of local anesthetic around the posterior muscles of the Spine. In this study, the investigators will make the injection with coloring solution on cadavers and by dissection will note the dispersion of the solution according to injectate volume. The investigators hypothesize more volume allows bigger spread and will allow new indications of this technique in perioperative analgesia and treatment of chronic Pain

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The study's methodology will include performing ultrasound guided erector spinae block in cadavers included in the study according to eligibility criteria. After signing of written consent form, the participants will be randomized on the height of the block (vertebral level - T3, T12 and L4) and the volume to be injected (10, 20 and 30ml). The block will be performed by experienced physicians on the technique by ultrasound guidance and fixed pressure measured with an in-line pressure monitor (15 psi) with the cadaver in the lateral position. The cadavers will be submitted to autopsy by standard thoracoabdominal midline incision, with the viscera removed for analysis. The cadavers will have their paraspinal muscles removed (quadratus lumborum and psoas major), the medial parietal pleura opened and the number of levels with colored solution registered, noting the spread to ventral rami of spinal nerves and to the paravertebral space.

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • SP
      • São Paulo, SP, Brazil, 01221-010
        • Irmandade Da Santa Casa De Misericordia De Sao Paulo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Fresh Cadavers (not subject to formaldehyde fixation process or frozen > 24h)
  • Age > 18 years
  • Written informed consent signed by responsible party
  • Height > 150cm and < 190cm

Exclusion Criteria:

  • Previous spinal surgery
  • Severe spinal deformity
  • BMI > 35 kg/m2
  • Absence of a responsible party to sign the written informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: T3 10ml
The cadaver will receive an ultrasound-guided Erector Spinae Plane Block with 10ml of coloring solution at the T3 vertebral level
Procedure: Erector Spinae Plane Block
Ultrasound guided injection of coloring solution (methylene blue diluted in water) with a 18G echogenic tuohy needle deep to the plane of the erector spinae muscles.
EXPERIMENTAL: T3 20ml
The cadaver will receive an ultrasound-guided Erector Spinae Plane Block with 20ml of coloring solution at the T3 vertebral level
Procedure: Erector Spinae Plane Block
Ultrasound guided injection of coloring solution (methylene blue diluted in water) with a 18G echogenic tuohy needle deep to the plane of the erector spinae muscles.
EXPERIMENTAL: T3 30ml
The cadaver will receive an ultrasound-guided Erector Spinae Plane Block with 30ml of coloring solution at the T3 vertebral level
Procedure: Erector Spinae Plane Block
Ultrasound guided injection of coloring solution (methylene blue diluted in water) with a 18G echogenic tuohy needle deep to the plane of the erector spinae muscles.
EXPERIMENTAL: T12 10ml
The cadaver will receive an ultrasound-guided Erector Spinae Plane Block with 10ml of coloring solution at the T12 vertebral level
Procedure: Erector Spinae Plane Block
Ultrasound guided injection of coloring solution (methylene blue diluted in water) with a 18G echogenic tuohy needle deep to the plane of the erector spinae muscles.
EXPERIMENTAL: T12 20ml
The cadaver will receive an ultrasound-guided Erector Spinae Plane Block with 20ml of coloring solution at the T12 vertebral level
Procedure: Erector Spinae Plane Block
Ultrasound guided injection of coloring solution (methylene blue diluted in water) with a 18G echogenic tuohy needle deep to the plane of the erector spinae muscles.
EXPERIMENTAL: T12 30ml
The cadaver will receive an ultrasound-guided Erector Spinae Plane Block with 30ml of coloring solution at the T12 vertebral level
Procedure: Erector Spinae Plane Block
Ultrasound guided injection of coloring solution (methylene blue diluted in water) with a 18G echogenic tuohy needle deep to the plane of the erector spinae muscles.
EXPERIMENTAL: L4 10ml
The cadaver will receive an ultrasound-guided Erector Spinae Plane Block with 10ml of coloring solution at the L4 vertebral level
Procedure: Erector Spinae Plane Block
Ultrasound guided injection of coloring solution (methylene blue diluted in water) with a 18G echogenic tuohy needle deep to the plane of the erector spinae muscles.
EXPERIMENTAL: L4 20ml
The cadaver will receive an ultrasound-guided Erector Spinae Plane Block with 20ml of coloring solution at the L4 vertebral level
Procedure: Erector Spinae Plane Block
Ultrasound guided injection of coloring solution (methylene blue diluted in water) with a 18G echogenic tuohy needle deep to the plane of the erector spinae muscles.
EXPERIMENTAL: L4 30ml
The cadaver will receive an ultrasound-guided Erector Spinae Plane Block with 30ml of coloring solution at the L4 vertebral level
Procedure: Erector Spinae Plane Block
Ultrasound guided injection of coloring solution (methylene blue diluted in water) with a 18G echogenic tuohy needle deep to the plane of the erector spinae muscles.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Spread of Coloring Solution secondary to volume injected and vertebral level of injection
Time Frame: 3 hours
Observation of coloring solution around the spinal nerves as they exit the vertebral foramen. Comparison of number of spinal nerves colored according to the volume injected and injection site.
3 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Spread of coloring solution to paravertebral space
Time Frame: 3 hours
Observation of coloring solution on the paravertebral space. Comparison of number of levels of the paravertebral space colored according to volume injected and injection site.
3 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Federal University of São Paulo

Collaborators

Irmandade da Santa Casa de Misericordia de Sao Paulo

Investigators

  • Principal Investigator: Andre L Casale, MD, Post Graduate

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

August 1, 2018

Primary Completion (ANTICIPATED)

April 30, 2019

Study Completion (ANTICIPATED)

May 31, 2019

Study Registration Dates

First Submitted

May 12, 2018

First Submitted That Met QC Criteria

May 22, 2018

First Posted (ACTUAL)

June 4, 2018

Study Record Updates

Last Update Posted (ACTUAL)

June 4, 2018

Last Update Submitted That Met QC Criteria

May 22, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • erector spinae plane block

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The research results will be published on indexed scientific journals, maintaining participant identity confidential

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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