Role of Left Stellate Ganglion Block in Offering Myocardial Protection in On-pump Mitral Valve Replacement? A Histopathological and Clinical Assessment

February 19, 2026 updated by: Mina Maher, Minia University
Can pre-operative left stellate ganglion block offer myocardial protection in on-pump mitral valve replacement? A histopathological and clinical assessment.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

62

Phase

  • Not Applicable

Contacts and Locations

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

Study Locations

  • Egypt
    • Minya Governorate
      • Minya, Minya Governorate, Egypt, 61511
        • Mina Raouf

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

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Adult population of both sex, between 25-50 years, will undergo elective on pump mitral valve replacement

Exclusion Criteria:

  • -Combined valve replacement ( mitral and aortic or mitral and tricuspid valves replacement).
  • Emergency valve replacement ( stuck valve, infective endocarditis).
  • Pre-operative cardiomyopathy (Ejection fraction less than 45%).
  • Recent myocardial infarction ( within 6 months)
  • Redo mitral valve replacement.
  • Pre-operative pacing, or cardioverter, any form arrhythmia ( tachy or brady).
  • Previous history of carotid endarterectomy or presence of carotid stent.
  • On thrombolytic therapy.
  • Severe chronic obstructive airway disease,
  • Patient refusal

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

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Control group
Sonar guided stellate ganglion injection of 8 ml of sterile saline 0.9% using high frequency probe as a placebo. Stellate ganglion is identified at the level of C6 just under the pulsation of the ipsilateral carotid artery
Procedure: sonar guided stellate ganglion injection
using high frequency probe, sonar guided stellate ganglion block with 8 ml saline 0.9%
Active Comparator: Stellate ganglion
Sonar guided stellate ganglion injection of 8ml bupivacaine 0.25% using high frequency probe. . Stellate ganglion is identified at the level of C6 just under the pulsation of the ipsilateral carotid artery
Procedure: sonar guided stellate ganglion block
using high frequency probe, sonar guided stellate ganglion block with 8 ml bupivacaine 0.25%

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of patients with microscopic myocardial injury
Time Frame: intra-operative
Biopsy from left papillary muscle to investigate microscopic evidence of cellular injury ( cytoplasmic oedema, hemorrhage and necrosis).
intra-operative

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intra-operative arrhythmia
Time Frame: intraoperatively
incidence of intraoperative atrial fibrillation
intraoperatively
postoperative arrhythmia
Time Frame: first, second and third day after bypass
Incidence of post operative atrial or ventricular arrhythmia
first, second and third day after bypass
Troponin I
Time Frame: before operation, immediately after ICU admission and 3 days post-operative
Serum troponin I to diagnose myocardial injury
before operation, immediately after ICU admission and 3 days post-operative
Myocardial function
Time Frame: pre-operative, one week
Ejection fraction
pre-operative, one week
weaning from mechanical ventilation
Time Frame: 24 hours post-operative
Time from ICU admission till successful extubation
24 hours post-operative
Time of cardiopulmonary bypass
Time Frame: Intraoperative
Intraoperative
Length of ICU stay
Time Frame: one week
one week
Need for pacing
Time Frame: intraoperative and one week after
intraoperative and one week after

Collaborators and Investigators

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

Sponsor

Minia University

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 (Actual)

July 15, 2024

Primary Completion (Actual)

March 15, 2025

Study Completion (Actual)

March 20, 2025

Study Registration Dates

First Submitted

June 18, 2024

First Submitted That Met QC Criteria

June 23, 2024

First Posted (Actual)

June 27, 2024

Study Record Updates

Last Update Posted (Actual)

February 23, 2026

Last Update Submitted That Met QC Criteria

February 19, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1130/4/2024

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.

Clinical Trials on Open Mitral Cardiac Surgery

Clinical Trials on sonar guided stellate ganglion injection

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Malta

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe