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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Federal University of São Paulo

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Irmandade da Santa Casa de Misericordia de Sao Paulo

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2018

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 30, 2019

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 31, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 12, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 22, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 4, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 4, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 22, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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