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

NCT ID: NCT05716061

Last Updated: 2023-08-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

4 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-17

Study Completion Date

2023-03-18

Brief Summary

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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

Detailed Description

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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

Conditions

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Nerve Block

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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median approach

Sacral ESPB performed from the median sacral crest of 2.level of sacrum.

Group Type EXPERIMENTAL

Sacral ESPB

Intervention Type PROCEDURE

Cadaver study

intermediate approach

Sacral ESPB performed bilateral and between the median and intermediate sacral crest of 2.level of sacrum.

Group Type ACTIVE_COMPARATOR

Sacral ESPB

Intervention Type PROCEDURE

Cadaver study

Interventions

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Sacral ESPB

Cadaver study

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Embalmed cadaver

Exclusion Criteria

* None of the cadavers had a history of trauma or surgery in the sacral region
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Karadeniz Technical University

OTHER

Sponsor Role collaborator

Ankara University

OTHER

Sponsor Role collaborator

Giresun University

OTHER

Sponsor Role lead

Responsible Party

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Bilge Olgun Keles

Assistant professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Necati Salman

Role: STUDY_CHAIR

Ankara University

Selami İnce

Role: STUDY_CHAIR

Beytepe Hospital

Elvan Tekir Yılmaz

Role: STUDY_CHAIR

Giresun University

Habip Birinci

Role: STUDY_CHAIR

Giresun University

Ali Faruk Özyaşar

Role: STUDY_CHAIR

Karadeniz Technical University

Aysun Uz

Role: STUDY_CHAIR

Ankara University

Locations

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Bilge Olgun Keleş

Giresun, Merkez, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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Tulgar S, Senturk O, Thomas DT, Deveci U, Ozer Z. A new technique for sensory blockage of posterior branches of sacral nerves: Ultrasound guided sacral erector spinae plane block. J Clin Anesth. 2019 Nov;57:129-130. doi: 10.1016/j.jclinane.2019.04.014. Epub 2019 Apr 15. No abstract available.

Reference Type RESULT
PMID: 30999197 (View on PubMed)

Aksu C, Gurkan Y. Sacral Erector Spinae Plane Block with longitudinal midline approach: Could it be the new era for pediatric postoperative analgesia? J Clin Anesth. 2020 Feb;59:38-39. doi: 10.1016/j.jclinane.2019.06.007. Epub 2019 Jun 13. No abstract available.

Reference Type RESULT
PMID: 31203111 (View on PubMed)

Hamilton DL. The erector spinae plane block: Time for clarity over anatomical nomenclature. J Clin Anesth. 2020 Jun;62:109699. doi: 10.1016/j.jclinane.2020.109699. Epub 2020 Jan 11. No abstract available.

Reference Type RESULT
PMID: 31935572 (View on PubMed)

Nanda M, Allan JD, Rojas A, Steele PJ, McMillan DT, Park J, Arora H, Grant SA. Anatomic evaluation of the sacral multifidus block. J Clin Anesth. 2021 Sep;72:110263. doi: 10.1016/j.jclinane.2021.110263. Epub 2021 Apr 5. No abstract available.

Reference Type RESULT
PMID: 33831768 (View on PubMed)

Ivanusic J, Konishi Y, Barrington MJ. A Cadaveric Study Investigating the Mechanism of Action of Erector Spinae Blockade. Reg Anesth Pain Med. 2018 Aug;43(6):567-571. doi: 10.1097/AAP.0000000000000789.

Reference Type RESULT
PMID: 29746445 (View on PubMed)

Aponte A, Sala-Blanch X, Prats-Galino A, Masdeu J, Moreno LA, Sermeus LA. Anatomical evaluation of the extent of spread in the erector spinae plane block: a cadaveric study. Can J Anaesth. 2019 Aug;66(8):886-893. doi: 10.1007/s12630-019-01399-4. Epub 2019 May 21.

Reference Type RESULT
PMID: 31119551 (View on PubMed)

Keles BO, Salman N, Yilmaz ET, Birinci HR, Apan A, Ince S, Ozyasar AF, Uz A. Comparison of the median and intermediate approaches to the ultrasound-guided sacral erector spinae plane block: a cadaveric and radiologic study. Korean J Anesthesiol. 2024 Feb;77(1):156-163. doi: 10.4097/kja.23604. Epub 2023 Nov 15.

Reference Type DERIVED
PMID: 37964515 (View on PubMed)

Other Identifiers

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2022/229 -13

Identifier Type: -

Identifier Source: org_study_id

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