NCT05716061

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 21, 2023

Completed
18 days until next milestone

First Posted

Study publicly available on registry

February 8, 2023

Completed
9 days until next milestone

Study Start

First participant enrolled

February 17, 2023

Completed
14 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 3, 2023

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 18, 2023

Completed
Last Updated

August 7, 2023

Status Verified

August 1, 2023

Enrollment Period

14 days

First QC Date

January 21, 2023

Last Update Submit

August 3, 2023

Conditions

Nerve Block

Keywords

cadaver studyerector spinae plane blockanatomic dissection

Outcome Measures

Primary Outcomes (2)

  • Completion of blocks for 4 cadavers

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

    3 days

  • Completion of computed tomography of 4 cadavers

    Computed tomography will be taken in 4 cadavers to observe the distribution of the radiocontrast material given to 2 different regions.

    3 day

Secondary Outcomes (1)

  • Completion of dissection of 4 cadavers

    3 days

Study Arms (2)

median approach

EXPERIMENTAL

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

Procedure: Sacral ESPB

intermediate approach

ACTIVE COMPARATOR

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

Procedure: Sacral ESPB

Interventions

Sacral ESPBPROCEDURE

Cadaver study

intermediate approachmedian approach

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Embalmed cadaver

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bilge Olgun Keleş

Giresun, Merkez, 28100, Turkey (Türkiye)

Location

Related Publications (7)

  • 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.

    PMID: 30999197RESULT

  • 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.

    PMID: 31203111RESULT

  • 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.

    PMID: 31935572RESULT

  • 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.

    PMID: 33831768RESULT

  • 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.

    PMID: 29746445RESULT

  • 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.

    PMID: 31119551RESULT

  • 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.

    PMID: 37964515DERIVED

Study Officials

  • 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

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

January 21, 2023

First Posted

February 8, 2023

Study Start

February 17, 2023

Primary Completion

March 3, 2023

Study Completion

March 18, 2023

Last Updated

August 7, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)