Perioperative Analgesia With Erector Spinae Plane Block in Liver Transplant Recipients

NCT06857331 | Recruiting DMC

• 1 other identifier: 190
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Liver Transplant; Erector Spina Plan Block

Outcome Measures

Primary Outcomes (3)

• Pain reduction postoperative

  Pain assessment with scores

  from enrollment to the 2nd postoperative day

• Opioid reduction intraoperatively

  The amount of intraoperative fentanyl

  from enrollment to the end of the operation

• Need for opioids postoperatively

  Need for opioids postoperatively

  from enrollment to the 2nd postoperative day

Study Arms (2)

Liver transplant recipients without regional anesthesia

NO INTERVENTION

Liver transplant recipients without regional anesthesia

Liver transplant recipients with regional anesthesia (ESP)

EXPERIMENTAL

ESP bilateral thoracic with a subsequent catheterization.

Procedure: Erector Spinae Plane Block using 0.2% ropivacaine

Interventions

Erector Spinae Plane Block using 0.2% ropivacaine PROCEDURE

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.

Liver transplant recipients with regional anesthesia (ESP)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bogomolets National Medical University: lead

Study Sites (1)

Universal Hospital Oberig

Kyiv, Ukraine

RECRUITING

MeSH Terms

Interventions

Ropivacaine

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Central Study Contacts

Nazarii Mysynchuk

CONTACT

+380731624586; n.mysynchuk@oberig.ua

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: February 26, 2025
• First Posted: March 4, 2025
• Study Start: May 5, 2024
• Primary Completion: September 30, 2025
• Study Completion: December 10, 2025
• Last Updated: March 4, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

UA (1)