Skip to content

Sympatholytic Effects of High Thoracic Erector Spinae Plane Block: Changes in Optic Nerve Sheath Diameter

Sympatholytic Effects of High Thoracic Erector Spinae Plane Block: A Prospective Observational Study on Changes in Optic Nerve Sheath Diameter

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06468384
Enrollment
15
Registered
2024-06-21
Start date
2024-06-20
Completion date
2024-09-20
Last updated
2024-06-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Complex Regional Pain Syndromes

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.

Interventions

PROCEDUREthoracic 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.

Sponsors

Pamukkale University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Optic nerve sheath diameter (ONSD)Before the block and 30 minutes after the block.To investigate the change in optic nerve sheath diameter (ONSD) following the thoracic erector spinae plane (ESP) block.

Secondary

MeasureTime frameDescription
Pain relief Visual Analog Scale (VAS)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.The Visual Analog Scale (VAS) is a tool for measuring pain intensity, using a line marked with no pain (0) at one end and worst pain imaginable (10) at the other. Patients mark a point on the line that reflects their pain level, and the distance from the no pain end to the mark is recorded as the VAS score. This straightforward, subjective measure provides a quantitative assessment of pain, useful for tracking changes over time, evaluating treatment effectiveness, and enhancing communication between patients and healthcare providers.
Monitoring of Perfusion Index (PI)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.The perfusion index (PI) is a numerical value that reflects the pulsatile blood flow in peripheral tissues, measured non-invasively using a pulse oximeter. It indicates the strength of the blood flow at the sensor site, providing valuable information about peripheral perfusion.

Contacts

Primary Contactismet çopur, MD
cpr.ismet@gmail.com05318469060
Backup Contactseher İlhan, Ass. prof
seheri@pau.edu.tr5326061086

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026