Clinical trial NCT05716061: A Cadaveric and Radiologic Study of Sacral Erector Spinae Plane Block (ESPB)
Official title: Comparison of Median, Intermediate and Lateral Approach to Sacral Erector Spinae Plane Block: a Cadaveric and Radiologic Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nerve Block
Keywords: cadaver study
erector spinae plane block
anatomic dissection
Lead sponsor: Giresun University
Sponsor class: OTHER
Collaborators: name: Karadeniz Technical University
name: Ankara University
First posted: 2023-02-08
Enrollment: 4
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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

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

Eligibility criteria: Inclusion Criteria:

* Embalmed cadaver

Exclusion Criteria:

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

Primary outcomes:
measure: Completion of blocks for 4 cadavers
timeFrame: 3 days
measure: Completion of computed tomography of 4 cadavers
timeFrame: 3 day
Secondary outcomes:
measure: Completion of dissection of 4 cadavers
timeFrame: 3 days
Other outcomes:
Locations:
city: Giresun
country: Turkey
facility: Bilge Olgun Keleş
state: Merkez
Study officials:
affiliation: Ankara University
name: Necati Salman
role: STUDY_CHAIR
affiliation: Beytepe Hospital
name: Selami İnce
role: STUDY_CHAIR
affiliation: Giresun University
name: Elvan Tekir Yılmaz
role: STUDY_CHAIR
affiliation: Giresun University
name: Habip Birinci
role: STUDY_CHAIR
affiliation: Karadeniz Technical University
name: Ali Faruk Özyaşar
role: STUDY_CHAIR
affiliation: Ankara University
name: Aysun Uz
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.