Nerve BlockESPBNCT05716061
A Cadaveric and Radiologic Study of Sacral Erector Spinae Plane Block (ESPB)
A study testing Sacral ESPB in people with Nerve Block, run by Giresun University at 1 site in Turkey (Türkiye).
Trial 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 Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Nerve Block
- What is being tested?
- Sacral ESPB
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 17 Feb 2023to 18 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Embalmed cadaver
Who cannot join
- None of the cadavers had a history of trauma or surgery in the sacral region
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
- Which nerves are affected by this block.
- Which approach is the best for optimal analgesia in human
Read the 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;
- 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
- Conditions
- Nerve Block
- Being tested
- Sacral ESPB
- Keywords
- cadaver study, erector spinae plane block, anatomic dissection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sacral ESPBProcedure or surgery
Cadaver study
| Study group | Role | What they receive |
|---|---|---|
| median approach | Experimental | Sacral ESPB performed from the median sacral crest of 2.level of sacrum. Receives: Procedure: Sacral ESPB |
| intermediate approach | Active comparator | Sacral ESPB performed bilateral and between the median and intermediate sacral crest of 2.level of sacrum. Receives: Procedure: Sacral ESPB |
What is being measured
The primary outcome is the main question the study is designed to answer.
Completion of blocks for 4 cadavers
Ultrasound guided sacral ESPB will be performed on 4 cadavers in 2 different approaches
Measured: 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.
Measured: 3 day
Secondary outcomes (1)
Completion of dissection of 4 cadavers
Four cadaveric specimens will be dissected in order to detect dye spread through tissue compartments
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2023
- Study start17 Feb 2023
- Primary completion3 Mar 2023
- Study completion18 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Nerve BlockStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Giresun University
- Sponsor type
- University, hospital or other
- Collaborators
- Karadeniz Technical University, Ankara University
- Responsible party
- Principal investigator, Bilge Olgun Keles, Giresun University
- Investigators
- Necati Salman, Study chair, Ankara UniversitySelami İnce, Study chair, Beytepe HospitalElvan Tekir Yılmaz, Study chair, Giresun UniversityHabip Birinci, Study chair, Giresun UniversityAli Faruk Özyaşar, Study chair, Karadeniz Technical UniversityAysun Uz, Study chair, Ankara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05716061
- Sponsor's protocol ID
- 2022/229 -13
- Acronym
- ESPB
- Status last verified
- Aug 2023
- First submitted
- 21 Jan 2023
- Last updated
- 7 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 30999197Aksu 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.
PubMed 31203111Hamilton 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.
PubMed 31935572Nanda 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.
PubMed 33831768Ivanusic 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.
PubMed 29746445Aponte 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.
PubMed 31119551Keles 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.
PubMed 37964515
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Median, Intermediate and Lateral Approach to Sacral Erector Spinae Plane Block: a Cadaveric and Radiologic Study
- ClinicalTrials.gov ID
- NCT05716061
- Acronym / sponsor ID
- ESPB / 2022/229 -13
- Conditions
- Nerve Block
- Keywords
- cadaver study, erector spinae plane block, anatomic dissection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Giresun UniversityUniversity, hospital or other
- Collaborators
- Karadeniz Technical University, Ankara University
- Study start
- 17 Feb 2023 (actual)
- Primary completion
- 3 Mar 2023 (actual)
- Study completion
- 18 Mar 2023 (actual)
- First posted
- 8 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Which nerves are affected by this block.
- 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;
- 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
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| median approach | Experimental | Procedure: Sacral ESPBSacral ESPB performed from the median sacral crest of 2.level of sacrum. |
| intermediate approach | Active comparator | Procedure: Sacral ESPBSacral ESPB performed bilateral and between the median and intermediate sacral crest of 2.level of sacrum. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Embalmed cadaver
Key exclusion criteria (1 listed)
- None of the cadavers had a history of trauma or surgery in the sacral region
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sacral ESPBCadaver study | Procedure or surgery | intermediate approach, median approach |
Primary outcome
Completion of blocks for 4 cadavers
Time frame: 3 days
Ultrasound guided sacral ESPB will be performed on 4 cadavers in 2 different approaches
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.
1 secondary outcome
Completion of dissection of 4 cadavers
Time frame: 3 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2023.
- Results publication: PubMed 30999197Tulgar 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.
- Results publication: PubMed 31203111Aksu 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.
- Results publication: PubMed 31935572Hamilton 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.
- Results publication: PubMed 33831768Nanda 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.
- Results publication: PubMed 29746445Ivanusic 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.
- Results publication: PubMed 31119551Aponte 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.
- Derived from this study: PubMed 37964515Keles 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.
- Individual participant dataSharing planned: No
Related trials for Nerve Block
RecruitingPhase 1
IL-17 Blockade to Decrease irAEs (REPLAY)
Metastatic Melanoma
Recruiting
Minimum Effective Local Anesthetic Volume for Ultrasound Guided Superior Trunk Block
Musculoskeletal Diseases or Conditions
Active, not recruiting
Efficacy of Laparoscopic-Assisted TAP Block in Laparoscopic Appendectomy
Appendectomy, Laparoscopic, Blockades Neuromuscular
Recruiting
SIRI Levels Following PENG Block in Pediatric Hip Surgery
Hip Dysplasia
Not yet recruiting
Effect of Pectoral Nerve Block (PECS) Using Magnesium Sulfate Added to Dexamethasone on Quality of Recovery and Chronic Post-Mastectomy Pain
Breast Cancer, Postoperative Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Necati Salman study chair
Ankara University
Selami İnce study chair
Beytepe Hospital
Elvan Tekir Yılmaz study chair
Giresun University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sacral ESPB in people with Nerve Block, run by Giresun University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Completion of blocks for 4 cadavers (time frame: 3 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05716061, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2023.