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Completed

NCT Number: NCT05716061

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

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

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Key information

Conditions

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bilge Olgun Keleş

Giresun, Merkez, 28100, Turkey (Türkiye)

About this study

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;

  • 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
  • Reconstruction and interpretation of radiology images: 1 week
  • Interpretation of anatomical dissection: 1 week
  • Evaluation and writing of the study: 1 month

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Embalmed cadaver

Exclusion criteria

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

Treatment and study plan

sacral ESPB

Procedure

Cadaver study

Primary outcomes

  1. Completion of blocks for 4 cadavers

    Time frame: 3 days

    Ultrasound guided sacral ESPB will be performed on 4 cadavers in 2 different approaches

  2. 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.

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Giresun University

Other

Collaborators

  • Ankara University
  • Karadeniz Technical University

Registry information

Official study title

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

Acronym: ESPB

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Feb 8, 2023
Registry last updated
Aug 7, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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