A Cadaveric and Radiologic Study of Sacral Erector Spinae Plane Block (ESPB) (ESPB)

August 3, 2023 updated by: Bilge Olgun Keles, Giresun University

Comparison of Median, Intermediate and Lateral Approach to Sacral Erector Spinae Plane Block: a Cadaveric and Radiologic Study

The goal of this cadaveric study is to learn about the distribution of contrast agent in ultrasound-guided sacral ESPB. The main questions it aims to answer are

  1. Which nerves are affected by this block.
  2. Which approach is the best for optimal analgesia in human

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

4 embalmed cadavers will be divided into groups of 2 and sacral ESPB will be made with 2 different methods. The cadavers will be removed from the solution 48 hours before and will be placed in the prone position, there will be no history of trauma or surgery in the sacral region of the cadavers, and no dissection will be performed from the sacral regions.

In the median approach, the probe will be placed on the cadaver, which was previously placed in the prone position, using a 12-18 megahertz high-frequency linear probe with ultrasound to form a right angle to the sacral crest. After being placed parallel to the sacrum and observing the median crest, a 50 mm echogenic needle will be inserted by advancing the implant towards the second sacral level. After touching the crest, the distribution will be observed by retreating 1mm and making 1 cc of serum physiologic. Then all 40 ml of methylene blue and radiocontrast solution will be given. In the intermediate approach; From the second sacral level, 20 ml of red acrylic dye and a solution containing radiocontrast will be given to the right and left by entering the sulcus between the median and intermedian crests with the same technique, using the same technique, under the guidance of ultrasound. After the procedure, sacral tomography will be performed on the cadavers. The spread of radiocontrast material will be observed and their reconstruction will be performed. Later, anatomical dissection will be performed on the cadavers and the spread of the dyes given will be observed. Which of the sacral intervention methods is more effective in clinical practice will be evaluated.

Estimated durations of the study;

  1. Removing the cadavers from the solution 48 hours before, performing the block, going to the radiology and performing the CT scan, coming to the anatomy laboratory and performing the dissection: 3 days
  2. Reconstruction and interpretation of radiology images: 1 week
  3. Interpretation of anatomical dissection: 1 week
  4. Evaluation and writing of the study: 1 month

Study Type

Interventional

Enrollment (Actual)

4

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

  • Turkey
    • Merkez
      • Giresun, Merkez, Turkey, 28100
        • Bilge Olgun Keleş

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Embalmed cadaver

Exclusion Criteria:

  • None of the cadavers had a history of trauma or surgery in the sacral region

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: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: median approach
Sacral ESPB performed from the median sacral crest of 2.level of sacrum.
Procedure: Sacral ESPB
Cadaver study
Active Comparator: intermediate approach
Sacral ESPB performed bilateral and between the median and intermediate sacral crest of 2.level of sacrum.
Procedure: Sacral ESPB
Cadaver study

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Completion of blocks for 4 cadavers
Time Frame: 3 days
Ultrasound guided sacral ESPB will be performed on 4 cadavers in 2 different approaches
3 days
Completion of computed tomography of 4 cadavers
Time Frame: 3 day
Computed tomography will be taken in 4 cadavers to observe the distribution of the radiocontrast material given to 2 different regions.
3 day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Completion of dissection of 4 cadavers
Time Frame: 3 days
Four cadaveric specimens will be dissected in order to detect dye spread through tissue compartments
3 days

Collaborators and Investigators

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

Sponsor

Giresun University

Collaborators

Ankara University
Karadeniz Technical University

Investigators

  • Study Chair: Necati Salman, Ankara University
  • Study Chair: Selami İnce, Beytepe Hospital
  • Study Chair: Elvan Tekir Yılmaz, Giresun University
  • Study Chair: Habip Birinci, Giresun University
  • Study Chair: Ali Faruk Özyaşar, Karadeniz Technical University
  • Study Chair: Aysun Uz, Ankara University

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 (Actual)

February 17, 2023

Primary Completion (Actual)

March 3, 2023

Study Completion (Actual)

March 18, 2023

Study Registration Dates

First Submitted

January 21, 2023

First Submitted That Met QC Criteria

January 28, 2023

First Posted (Actual)

February 8, 2023

Study Record Updates

Last Update Posted (Actual)

August 7, 2023

Last Update Submitted That Met QC Criteria

August 3, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2022/229 -13

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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