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

June 15, 2024 updated by: ismet çopur, Pamukkale University

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

15

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Optic nerve sheath diameter (ONSD)
Time Frame: 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.
Before the block and 30 minutes after the block.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain relief Visual Analog Scale (VAS)
Time Frame: 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.
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.
Monitoring of Perfusion Index (PI)
Time Frame: 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.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pamukkale University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 20, 2024

Primary Completion (Estimated)

August 20, 2024

Study Completion (Estimated)

September 20, 2024

Study Registration Dates

First Submitted

June 15, 2024

First Submitted That Met QC Criteria

June 15, 2024

First Posted (Actual)

June 21, 2024

Study Record Updates

Last Update Posted (Actual)

June 21, 2024

Last Update Submitted That Met QC Criteria

June 15, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PAU-ANEST-SI-IC-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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