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Clinical Trials/NCT06857331
NCT06857331RecruitingNot Applicable

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

Bogomolets National Medical University1 site in 1 country50 target enrollmentStarted: May 5, 2024Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
50
Locations
1
Primary Endpoint
Opioid reduction intraoperatively

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

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.

Intervention: Erector Spinae Plane Block using 0.2% ropivacaine (Procedure)

Outcomes

Primary Outcomes

Opioid reduction intraoperatively

Time Frame: from enrollment to the end of the operation

The amount of intraoperative fentanyl

Need for opioids postoperatively

Time Frame: from enrollment to the 2nd postoperative day

Need for opioids postoperatively

Pain reduction postoperative

Time Frame: from enrollment to the 2nd postoperative day

Pain assessment with scores

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Nazarii Mysynchuk

MD

Bogomolets National Medical University

Study Sites (1)

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