Clinical trial NCT06468384: Sympatholytic Effects of High Thoracic Erector Spinae Plane Block: Changes in Optic Nerve Sheath Diameter
Official title: Sympatholytic Effects of High Thoracic Erector Spinae Plane Block: A Prospective Observational Study on Changes in Optic Nerve Sheath Diameter
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Complex Regional Pain Syndromes
Lead sponsor: Pamukkale University
Sponsor class: OTHER
First posted: 2024-06-21
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: * Adults with neck, shoulder, and arm pain
* 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

Brief summary: The thoracic erector spinae plane (ESP) block is suggested to potentially affect the stellate ganglion, a key component of the sympathetic nervous system, thereby influencing autonomic functions. Changes in optic nerve sheath diameter (ONSD) are used as indicators of intracranial pressure changes. This study aims to investigate the effects of the ESP block on ONSD, providing insights into its impact on the stellate ganglion and enhancing the understanding of the ESP block's safety and efficacy.

Detailed description: The thoracic erector spinae plane (ESP) block is a regional anesthesia technique. This technique involves the injection of local anesthetics into the deep layers of the erector spinae muscles, blocking both somatic and visceral pain pathways. Although various studies have been conducted on the effectiveness of this technique in different clinical situations over the years, further research is needed to understand the precise mechanisms behind its neuroanatomical effects.

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.

Eligibility criteria: Inclusion Criteria:

* Adults with neck, shoulder, and arm pain
* 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:

* Those who refuse procedures and tests
* 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

Primary outcomes:
measure: Optic nerve sheath diameter (ONSD)
timeFrame: Before the block and 30 minutes after the block.
Secondary outcomes:
measure: Pain relief Visual Analog Scale (VAS)
timeFrame: Pain levels will be assessed using the VAS before the block, 30 minutes after the block, and 24 hours later to evaluate the effectiveness of the intervention.
measure: Monitoring of Perfusion Index (PI)
timeFrame: All perfusion index (PI) values will be measured at 3-minute intervals using 2 pulse oximeter sensors on both the blocked and contralateral unblocked upper extremities up to 30 minutes after local anesthetic injection.
Other outcomes:
Locations:
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.