Perioperative Analgesia with Erector Spinae Plane Block in Liver Transplant Recipients

February 26, 2025 updated by: Nazarii Mysynchuk, Bogomolets National Medical University

Optimization of Perioperative Analgesia with Erector Spinae Plane Block During Major Abdominal Surgeries in Patients with Impaired Liver Function

The goal of this clinical trial is to learn if ESP block is safe and effective for perioperative analgesia in patients undergoing liver transplant. The main question it aims to answer are Is ESP block safe and has a minimum side effects, like hematoma? Is it effective for perioperative analgesia? Researchers will compare the results to a group of patients who underwent liver transplants without any regional anaesthesia techniques.

Participants will receive bilateral thoracic ESP block on the day of the transplantation with a subsequent bilateral catheterization.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

50

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 Contact

Study Locations

  • Ukraine
      • Kyiv, Ukraine
        • Recruiting
        • Universal Hospital Oberig
        • Contact:
        • Contact:
          • Nazarii Mysynchuk

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • impaired liver function - cirrhosis or chronic liver disease with the development of hypocoagulation (APTT > 35 sec, INR > 1.5), thrombocytopenia, patients requiring major abdominal surgery, age > 18 years, written consent to participate in the study was obtained

Exclusion Criteria:

  • Platelet count <50x109, failed ESP catheterization unilateral or bilateral, failed epidural anesthesia attempt, history of allergy or hypersensitivity to local anesthetics, hepatopulmonary syndrome, patients on mechanical ventilation before surgery, patients on CRRT before surgery, refusal to participate in the study

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: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Liver transplant recipients without regional anesthesia
Experimental: Liver transplant recipients with regional anesthesia (ESP)
ESP bilateral thoracic with a subsequent catheterization.
Procedure: Erector Spinae Plane Block using 0.2% ropivacaine
Bilateral thoracic ESP block on the day of the transplantation with a subsequent catheterization will be suggested for the patients. In case of their written consent for the participation in the study this procedure will be performed on the day of the operation. 0.2% ropivacaine is going to be used throughout all the perioperative period.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain reduction postoperative
Time Frame: from enrollment to the 2nd postoperative day
Pain assessment with scores
from enrollment to the 2nd postoperative day
Opioid reduction intraoperatively
Time Frame: from enrollment to the end of the operation
The amount of intraoperative fentanyl
from enrollment to the end of the operation
Need for opioids postoperatively
Time Frame: from enrollment to the 2nd postoperative day
Need for opioids postoperatively
from enrollment to the 2nd postoperative day

Collaborators and Investigators

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

Sponsor

Bogomolets National Medical 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)

May 5, 2024

Primary Completion (Estimated)

September 30, 2025

Study Completion (Estimated)

December 10, 2025

Study Registration Dates

First Submitted

February 26, 2025

First Submitted That Met QC Criteria

February 26, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 26, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 190

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

product manufactured in and exported from the U.S.

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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