Anesthesia, LocalESPNCT05674006
Ultrasound Guided Sacral Erector Spina Plane Block as a Main Anesthetic Method
An observational study of Anesthesia, Local, run by Samsun University at 1 site in Turkey (Türkiye).
Trial summary
The goal of this retrospective observational study is to demonstrate investigators' experience of Ultrasound guided Sacral Erector Spina Plane Block as an anesthetic technique in patients underwent sacral plastic and reconstructive surgeries. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anesthesia, Local
- How many people
- 10 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 Jan 2023to 16 Mar 2023
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All ASA1-4 patients of age older than18 going for a sacral surgery
Who may be able to join
- being going for a sacral surgery
- American Society of Anesthesiology status (ASA) 1 - 4
Who cannot join
- emergency
- ASA-5
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ultrasound Guided Sacral Erector Spina Plane Block as a Main Anesthetic Method: Single Center Experience
The goal of this retrospective observational study is to demonstrate investigators' experience of Ultrasound guided Sacral Erector Spina Plane Block as an anesthetic technique in patients underwent sacral plastic and reconstructive surgeries.
The main question[s] it aims to answer are:
- block indication, level
- results, side effects and complications
Read the detailed description
Erector Spina Plane Block is an interfascial plane block that is performed by injecting the local anesthetic solution between transverse process of the vertebra and erector spina muscle. It is found to be an inexpensive,easily applied, effective and safe technique for chronic pain.(1) Ultrasound guided Erector Spina Plane Block(ESP) is getting more and more widely used for analgesia and as an anesthetic technique.(2,3) Regional anesthesia techniques provide safer, more stable and advantageous anesthetic management, especially in high-risk patients. Ultrasound guided Sacral ESP is described by Tulgar et all.in 2019 and can be used either for analgesia or as an anesthetic technique. (4) In this retrospective study investigators planed to demonstrate one year of experience of this block for sacral plastic and reconstructive surgery. Demographic data of patients who underwent sacral surgery with sacral ESP block, indication of block, level of block, drug dose concentration, effect, side effect and results that were recorded will be analyzed.
- Conditions
- Anesthesia, Local
- Keywords
- Anesthesia, ESP, Sacral
What is being measured
The primary outcome is the main question the study is designed to answer.
Block success
Effectiveness of Sacral Erector Spinae Plane Block as an Anesthetic technique
Measured: up to 1 year
Secondary outcomes (1)
Number and amount of required perioperative analgesic/anesthetic drugs
The number and amount of drugs administered will be determined from the anesthesia file records when the patient feels pain or shows dissatisfaction with anesthesia.
Measured: up to 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2023
- Study start25 Jan 2023
- Primary completion16 Mar 2023
- Study completion16 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Anesthesia, LocalStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsun University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Serkan Tulgar, Study chair, Samsun University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05674006
- Sponsor's protocol ID
- SamsunU_sakral_ESP
- Acronym
- ESP
- Status last verified
- Mar 2023
- First submitted
- 30 Dec 2022
- Last updated
- 17 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Unal Artik HA, Gulpinar TO, Halis A, Celebi N. Erector spinae plane block in chronic pain: a retrospective study. Turk J Med Sci. 2022 Aug;52(4):1408-1410. doi: 10.55730/1300-0144.5449. Epub 2022 Aug 10.
PubMed 36326408Kaya C, Dost B, Tulgar S. Sacral Erector Spinae Plane Block Provides Surgical Anesthesia in Ambulatory Anorectal Surgery: Two Case Reports. Cureus. 2021 Jan 9;13(1):e12598. doi: 10.7759/cureus.12598.
PubMed 33585088Ahiskalioglu A, Tulgar S, Celik M, Ozer Z, Alici HA, Aydin ME. Lumbar Erector Spinae Plane Block as a Main Anesthetic Method for Hip Surgery in High Risk Elderly Patients: Initial Experience with a Magnetic Resonance Imaging. Eurasian J Med. 2020 Feb;52(1):16-20. doi: 10.5152/eurasianjmed.2020.19224.
PubMed 32158307Tulgar 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 30999197
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Guided Sacral Erector Spina Plane Block as a Main Anesthetic Method: Single Center Experience
- ClinicalTrials.gov ID
- NCT05674006
- Acronym / sponsor ID
- ESP / SamsunU_sakral_ESP
- Conditions
- Anesthesia, Local
- Keywords
- Anesthesia, ESP, Sacral
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Samsun UniversityUniversity, hospital or other
- Study start
- 25 Jan 2023 (actual)
- Primary completion
- 16 Mar 2023 (actual)
- Study completion
- 16 Mar 2023 (actual)
- First posted
- 6 Jan 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 retrospective observational study is to demonstrate investigators' experience of Ultrasound guided Sacral Erector Spina Plane Block as an anesthetic technique in patients underwent sacral plastic and reconstructive surgeries.
The main question[s] it aims to answer are:
- block indication, level
- results, side effects and complications
Detailed description
Erector Spina Plane Block is an interfascial plane block that is performed by injecting the local anesthetic solution between transverse process of the vertebra and erector spina muscle. It is found to be an inexpensive,easily applied, effective and safe technique for chronic pain.(1) Ultrasound guided Erector Spina Plane Block(ESP) is getting more and more widely used for analgesia and as an anesthetic technique.(2,3) Regional anesthesia techniques provide safer, more stable and advantageous anesthetic management, especially in high-risk patients. Ultrasound guided Sacral ESP is described by Tulgar et all.in 2019 and can be used either for analgesia or as an anesthetic technique. (4) In this retrospective study investigators planed to demonstrate one year of experience of this block for sacral plastic and reconstructive surgery. Demographic data of patients who underwent sacral surgery with sacral ESP block, indication of block, level of block, drug dose concentration, effect, side effect and results that were recorded will be analyzed.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All ASA1-4 patients of age older than18 going for a sacral surgery
Key inclusion criteria (2 listed)
- being going for a sacral surgery
- American Society of Anesthesiology status (ASA) 1 - 4
Key exclusion criteria (2 listed)
- emergency
- ASA-5
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Block success
Time frame: up to 1 year
Effectiveness of Sacral Erector Spinae Plane Block as an Anesthetic technique
1 secondary outcome
Number and amount of required perioperative analgesic/anesthetic drugs
Time frame: up to 2 hours
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 17 Mar 2023.
- Background: PubMed 36326408Unal Artik HA, Gulpinar TO, Halis A, Celebi N. Erector spinae plane block in chronic pain: a retrospective study. Turk J Med Sci. 2022 Aug;52(4):1408-1410. doi: 10.55730/1300-0144.5449. Epub 2022 Aug 10.
- Background: PubMed 33585088Kaya C, Dost B, Tulgar S. Sacral Erector Spinae Plane Block Provides Surgical Anesthesia in Ambulatory Anorectal Surgery: Two Case Reports. Cureus. 2021 Jan 9;13(1):e12598. doi: 10.7759/cureus.12598.
- Background: PubMed 32158307Ahiskalioglu A, Tulgar S, Celik M, Ozer Z, Alici HA, Aydin ME. Lumbar Erector Spinae Plane Block as a Main Anesthetic Method for Hip Surgery in High Risk Elderly Patients: Initial Experience with a Magnetic Resonance Imaging. Eurasian J Med. 2020 Feb;52(1):16-20. doi: 10.5152/eurasianjmed.2020.19224.
- Background: 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.
- Individual participant dataSharing planned: No
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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.
Serkan Tulgar study chair
Samsun University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anesthesia, Local, run by Samsun 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 2 inclusion and 2 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 17 Mar 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?
Block success (time frame: up to 1 year). 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 NCT05674006, which also lists 4 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 17 Mar 2023.