Erector Spinae Plane Block in Liver Transplantation Donors

August 3, 2023 updated by: Tumay Uludag Yanaral, Medipol University

Ultrasound-guided Bilateral Erector Spinalis Plane Block on Postoperative Pain Management in Liver Transplantation Donors

Living donor liver transplantation has become a common treatment option for patients with end-stage liver disease. Donor hepatectomy is associated with significant postoperative pain due to inverted L-shaped incision. Therefore adequate analgesia is important for recovery.

Erector Spinae Plane Block (ESPB) is a safe anesthesia technique used to provide postoperative analgesia. This study aimed to compare the novel ultrasound-guided ESPB technique with controls in terms of postoperative opioid consumption and postoperative pain control on donor patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

41

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

  • Turkey
      • Istanbul, Turkey, 34070
        • Istanbul Medipol University Hospital

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

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Donor patients scheduled for elective hepatectomy in liver transplantation surgery
  • ASA I-II
  • Patients who are aged between 18-65

Exclusion Criteria:

  • Patients who do not accept the procedure
  • Skin infection at the site of Erector Spina Plan Block area
  • Coagulation disorder or using anticoagulant drugs
  • Known local anesthetics and opioid allergy
  • Severe pulmonary and/or cardiovascular problems
  • Substance addiction or known psychiatric or mental problems
  • Chronic painkiller usage
  • Pregnancy or lactation

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Erector Spinae Plane Block
Erector Spinae Plane Block for Postoperative Analgesia
Procedure: Erector Spinae Plane Block
Intravenous fentanyl patient control device 48-hour fentanyl consumption will be recorded.
Active Comparator: Control group
No regional anesthesia technique will be applied to the control group.
Procedure: Intravenous fentanyl patient control device
Intravenous fentanyl patient control device 48-hour fentanyl consumption will be recorded.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Opioid consumption
Time Frame: Change from baseline opioid consumption at postoperative 0, 2, 4, 6, 12, 24, 36 and 48 hours
The amount of fentanyl required by the patient and given by the device will be recorded for the first 48 hours.
Change from baseline opioid consumption at postoperative 0, 2, 4, 6, 12, 24, 36 and 48 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual Analog Scale
Time Frame: Change from baseline pain scores at postoperative 0, 2, 4, 6, 12, 24, 36 and 48 hours
Pain of patients will be evaluated and recorded according to the Visual Analog Scale.
Change from baseline pain scores at postoperative 0, 2, 4, 6, 12, 24, 36 and 48 hours

Collaborators and Investigators

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

Sponsor

Medipol University

Investigators

  • Principal Investigator: Tumay Uludag Yanaral, Medipol 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 (Actual)

December 24, 2020

Primary Completion (Actual)

May 1, 2023

Study Completion (Actual)

August 1, 2023

Study Registration Dates

First Submitted

June 1, 2022

First Submitted That Met QC Criteria

June 1, 2022

First Posted (Actual)

June 6, 2022

Study Record Updates

Last Update Posted (Actual)

August 7, 2023

Last Update Submitted That Met QC Criteria

August 3, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MEDIPOLU-973

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.

Clinical Trials on Pain, Postoperative

Clinical Trials on Erector Spinae Plane Block

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Azerbaijan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe