Sympatholytic Effects of High Thoracic Erector Spinae Plane Block: Changes in Optic Nerve Sheath Diameter
NCT ID: NCT06468384
Last Updated: 2024-06-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
NOT_YET_RECRUITING
15 participants
OBSERVATIONAL
2024-06-20
2024-09-20
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
The Evaluation of Erector Spinae Plane Block for the Pain Control of Thoracic Postherpetic Neuralgia
NCT03595046
Comparison of the Efficacy of Two Different Suprascapular Nerve Block Techniques in Patients With Chronic Shoulder Pain
NCT04938037
Cervical Epidural and Stellate Ganglion Block in Upper Limb Complex Regional Pain Syndrome
NCT05970146
Efficacy of Cervical Epidural Injection and Selective Nerve Root Block
NCT05340179
Clinical Efficacy of Axillary Block in Cervical Radiculopathy
NCT05723354
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
The stellate ganglion, an important component of the sympathetic nervous system, plays a crucial role in the regulation of several autonomic functions. It has been suggested that the ESP block may affect the stellate ganglion through its injection at the upper thoracic levels. Changes in the optic nerve sheath diameter (ONSD) have been used as an important indicator of intracranial pressure changes. Any potential changes in ONSD following stellate ganglion blockade could help elucidate the effects of the ESP block, thus aiding in the understanding of its safety and potential benefits for analgesia.
The aim of this study is to investigate the changes in optic nerve sheath diameter in patients undergoing the thoracic ESP block, which could provide more information on the impact of the ESP block on the stellate ganglion. By doing so, we aim to gain further insights into the potential analgesic effects and safety of the ESP block.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Patients Undergoing Thoracic Erector Spinae Plane Block
The study focuses on a cohort of adult patients who are receiving the thoracic erector spinae plane (ESP) block for pain management. These patients include individuals experiencing pain in the shoulder, arm, or neck, as well as those with complex regional pain syndrome. The patients are generally healthy adults, categorized under ASA I-II (American Society of Anesthesiologists Physical Status Classification System). The primary aim of the study is to observe changes in optic nerve sheath diameter (ONSD) following the ESP block and to investigate the potential impact on the stellate ganglion. Data will be collected through clinical examinations and ultrasound performed before and after the ESP block procedure. The study aims to enhance understanding of the ESP block's safety and potential autonomic effects.
thoracic erector spinae plane (ESP) block
The thoracic erector spinae plane (ESP) block is a regional anesthesia technique used for pain management in complex regional pain syndrome. This procedure involves injecting 20 ml of 0.25% bupivacaine into the deep layers of the erector spinae muscles. The patient is positioned appropriately, and the injection site is identified using anatomical landmarks and ultrasound guidance, at the T2 level. A needle is then inserted perpendicularly until it contacts the transverse process, at which point the local anesthetic is administered. The primary objective is to provide significant pain relief.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
thoracic erector spinae plane (ESP) block
The thoracic erector spinae plane (ESP) block is a regional anesthesia technique used for pain management in complex regional pain syndrome. This procedure involves injecting 20 ml of 0.25% bupivacaine into the deep layers of the erector spinae muscles. The patient is positioned appropriately, and the injection site is identified using anatomical landmarks and ultrasound guidance, at the T2 level. A needle is then inserted perpendicularly until it contacts the transverse process, at which point the local anesthetic is administered. The primary objective is to provide significant pain relief.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Those with complex regional pain syndrome
The study will include 15 adult patients who are planned to receive T2-ESP block treatment.
* Age between 18-65 years
* Both genders
* ASA physical status I-II
Exclusion Criteria
* Individuals with conditions that can increase intracranial pressure
* Those with severe heart failure
* Individuals with second or third-degree atrioventricular block
* Those with a history of unstable angina
* Individuals with COPD or chronic asthma
* Those who have experienced a myocardial infarction (MI) within the last 6 weeks
* Individuals with a heart rate below 50 beats per minute
* Those with systolic blood pressure below 90 mmHg
* Individuals with liver failure
* Those with kidney failure
* Individuals for whom a supraclavicular block is anatomically impossible
* Those with neurological or psychological conditions that complicate test evaluation
* Individuals allergic to any of the study medications
* Pregnant individuals
18 Years
65 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Pamukkale University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
ismet çopur
principal investigator
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
References
Explore related publications, articles, or registry entries linked to this study.
Chin KJ, El-Boghdadly K. Mechanisms of action of the erector spinae plane (ESP) block: a narrative review. Can J Anaesth. 2021 Mar;68(3):387-408. doi: 10.1007/s12630-020-01875-2. Epub 2021 Jan 6.
Shirodkar CG, Munta K, Rao SM, Mahesh MU. Correlation of measurement of optic nerve sheath diameter using ultrasound with magnetic resonance imaging. Indian J Crit Care Med. 2015 Aug;19(8):466-70. doi: 10.4103/0972-5229.162465.
Kim E, Lim JA, Choi CH, Lee SY, Kwak S, Kim J. Assessment of the changes in cardiac sympathetic nervous activity using the pupil size changes measured in seated patients whose stellate ganglion is blocked by interscalene brachial plexus block. Korean J Anesthesiol. 2023 Apr;76(2):116-127. doi: 10.4097/kja.22324. Epub 2022 Oct 24.
Maissan IM, Dirven PJ, Haitsma IK, Hoeks SE, Gommers D, Stolker RJ. Ultrasonographic measured optic nerve sheath diameter as an accurate and quick monitor for changes in intracranial pressure. J Neurosurg. 2015 Sep;123(3):743-7. doi: 10.3171/2014.10.JNS141197. Epub 2015 May 8.
Kim MS, Yoon KB, Yoon DM, Kim DH. Effect of cervical sympathetic block on optic nerve sheath diameter measured by ultrasonography. Ultrasound Med Biol. 2015 Jun;41(6):1599-604. doi: 10.1016/j.ultrasmedbio.2015.01.025. Epub 2015 Mar 5.
Dautzenberg KHW, Zegers MJ, Bleeker CP, Tan ECTH, Vissers KCP, van Geffen GJ, van der Wal SEI. Unpredictable Injectate Spread of the Erector Spinae Plane Block in Human Cadavers. Anesth Analg. 2019 Nov;129(5):e163-e166. doi: 10.1213/ANE.0000000000004187.
Forero M, Peng P, Chan P. Horner syndrome following high thoracic erector spinae plane block. Can J Anaesth. 2022 Mar;69(3):400-401. doi: 10.1007/s12630-021-02177-x. Epub 2021 Dec 13. No abstract available.
Elkoundi A, Eloukkal Z, Bensghir M, Belyamani L. Priapism following erector spinae plane block for the treatment of a complex regional pain syndrome. Am J Emerg Med. 2019 Apr;37(4):796.e3-796.e4. doi: 10.1016/j.ajem.2019.01.012. Epub 2019 Jan 11.
Hong JH, Park JH, Park KB, Lee JY. Sympatholytic Effect of the High Thoracic Erector Spinae Plane Block. Pain Physician. 2024 Jan;27(1):43-49.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
PAU-ANEST-SI-IC-01
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.