Determination Of Dispersion In Ultrasound Guided Quadratus Lumborum Block In Cadavers

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

Determination Of The Relationship Between Local Anesthetic Volume And Its Dispersion In Ultrasound Guided Quadratus Lumborum Block In Cadavers

Lumbar Quadrant Blockade is a recent analgesic technique consisting of the injection of local anesthetic around the lumbar square muscle. It was initially described as a technique for abdominal wall analgesia, but later studies have increased the range of indications for laparoscopic and lower limb surgeries. There are several techniques described but with differences in the literature at the point of injection and volume of anesthetic. The exact mechanism of visceral analgesia has not yet been determined. The objective of this study is to determine the dispersion of local anesthetic as a variable dependent on the volume of local anesthetic and injection site and elucidate the mechanisms of analgesia.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

After the free and informed consent signed by the family authorizing the procedure, demographic and clinical data will be collected from the medical records of the deceased. The corpse will be weighed, measured and placed on the autopsy table. Blockade randomization (QLB 2 or QLB 3) and volume of local anesthetic (10ml, 20ml, 30ml) will be performed for each side. Injection in the anterior or posterior plane to the Lumbar Quadrant muscle will be performed by anesthesiologists experienced in the technique with ultrasound aid. A colouring solution will be used. After confirming the correct needle position, the previously randomized volumes will be injected. After the blockage, the corpse will be placed in the supine position and will be submitted to autopsy by standard procedure. After removal of the thoracic and abdominal viscera, the investigators will verify the dispersion of the local anesthetic. Photographic records will be made and the number of levels by which the solution dispersed will be annotated, calculating the number of cranial and caudal levels. The corpse will then have its autopsy procedure completed, with the placement of the viscera and incision closure according to the service standard.

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
      • Sao Paulo, SP, Brazil, 01221020
        • Irmandade de Misericórdia da Santa Casa De São Paulo
        • Contact:
        • Principal Investigator:
          • Marilia Tassinari Gonçalves Preza, MD
        • Sub-Investigator:
          • Andre L Valsecchi Casale, MD

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 corpses - not subjected to a formaldehyde process or frozen for more than 24 hours
  • Age ≥ 18 years.
  • Free, informed and informed consent signed by relatives or guardians of the body.
  • Height> 150 cm and <190 cm

Exclusion Criteria:

  • Previous spinal surgery.
  • Significant spinal deformity
  • Body mass index (BMI) ≥ 35 kg / m2
  • Absence of relatives or guardians who can sign the written 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 Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: QLB 2 10ml
The cadaver will receive an ultrasound- guided Quadratus Lumborum Block type 2 with 10 ml coloring solution
Procedure: Quadratus Lumborum Block type 2
Ultrasound guided injection of coloring solution using a 18g Tuohy echogenic needle, posterior to the Quadratus Lumborum muscle
Experimental: QLB 2 20ml
The cadaver will receive an ultrasound- guided Quadratus Lumborum Block type 2 with 20 ml coloring solution
Procedure: Quadratus Lumborum Block type 2
Ultrasound guided injection of coloring solution using a 18g Tuohy echogenic needle, posterior to the Quadratus Lumborum muscle
Experimental: QLB 2 30ml
The cadaver will receive an ultrasound- guided Quadratus Lumborum Block type 2 with 30 ml coloring solution
Procedure: Quadratus Lumborum Block type 2
Ultrasound guided injection of coloring solution using a 18g Tuohy echogenic needle, posterior to the Quadratus Lumborum muscle
Experimental: QLB 3 10ml
The cadaver will receive an ultrasound- guided Quadratus Lumborum Block type 3 with 10 ml coloring solution
Procedure: Quadratus Lumborum Block type 3
Ultrasound guided injection of coloring solution using a 18g Tuohy echogenic needle, anterior to the Quadratus Lumborum muscle
Experimental: QLB 3 20ml
The cadaver will receive an ultrasound- guided Quadratus Lumborum Block type 3 with 20 ml coloring solution
Procedure: Quadratus Lumborum Block type 3
Ultrasound guided injection of coloring solution using a 18g Tuohy echogenic needle, anterior to the Quadratus Lumborum muscle
Experimental: QLB 3 30ml
The cadaver will receive an ultrasound- guided Quadratus Lumborum Block type 3 with 30 ml coloring solution
Procedure: Quadratus Lumborum Block type 3
Ultrasound guided injection of coloring solution using a 18g Tuohy echogenic needle, anterior to the Quadratus Lumborum muscle

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Spread of coloring solution according to the volume injected
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.
3 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Spread of coloring solution to the paravertebral space
Time Frame: 3 hours
Observation of coloring solution on the paravertebral space. Comparison of spread to the paravertebral space according to the volume injected.
3 hours
Comparison of spread of the coloring solution between QLB 2 and QLB3
Time Frame: 3 hours
Observation of coloring solution around the spinal nerves as they exit the vertebral foramen and spread to the paravertebral space. Comparison of number of spinal nerves colored according to the technique used.
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: Marilia Tassinari Gonçalves Preza, 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

  • Quadratus lumborum block

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

The research results will be published in indexed scientific journals, maintaining participants 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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