Comparison of the Postoperative Analgesic Effects of ITM and Bi-level ESPB in Liver Transplantation Donors

August 18, 2025 updated by: Atakan Sezgi, Ankara Etlik City Hospital

Comparison of the Postoperative Analgesic Effects of Intrathecal Morphine and Bi-level Erector Spinae Plane Block in Liver Transplantation Donors

Liver transplantation is a life-saving procedure for patients with end-stage liver disease, and postoperative pain management is critical for optimizing donor recovery and overall outcomes. Poorly controlled pain following donor hepatectomy may reduce quality of life, delay mobilization, and contribute to the development of chronic pain syndromes.

Regional anesthesia techniques, such as intrathecal morphine and erector spinae plane block, have been utilized to enhance postoperative analgesia and reduce perioperative opioid requirements, potentially minimizing opioid-related adverse effects.

In this study, we aimed to compare the postoperative analgesic efficacy of intrathecal morphine and Bi-level erector spinae plane block in living liver donors.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

60

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 Contact Backup

Study Locations

  • Turkey
    • Ankara
      • Altındağ, Ankara, Turkey, 06000
        • Recruiting
        • Ankara Etlik City Hospital
        • Contact:
        • Contact:

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
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients aged 18-65 years
  • American Society of Anesthesiologists (ASA) score I-II
  • Body Mass Index (BMI) between 18-30 kg/m2

Exclusion Criteria:

  • Patients under 18 and over 65 years of age
  • ASA score III and above
  • Patients with a history of bleeding diathesis
  • BMI below 18 or above 30 kg/m2

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: Intrathecal Morphine

An intrathecal injection of morphine 300μg will be administered at the L3-L4 or L4-L5 level.

In the intraoperative period, intravenous meperidine 0.5 mg/kg will be given 30min before the end of surgery.
Procedure: Intrathecal Morphine

An intrathecal injection of morphine 300μg will be administered at the L3-L4 or L4-L5 level.

Additionally, in the postoperative period a dexketoprofen dose of 50 mg twice daily were administered iv for multimodal analgesia.
Active Comparator: Bi-level Erector Spinae Plane Block

After the linear ultrasound (US) probe will be placed 2-3 cm lateral to the T8 spinous process, 10 ml of 0.25% bupivacaine hydrochloride will be injected cauda-cranially into the interfacial space below the erector spinae muscle, above the transverse process. Next, the needle will be withdrawn till subcutaneously and the linear US probe will be placed 2-3 cm lateral to the T10 spinous process. Finally, 10 ml of 0.25% bupivacaine hydrochloride will be injected cranio-caudally into the interfacial space below the erector spinae muscle, above the transverse process.

This procedure will be performed bilaterally. A total of 40 ml of 0.25% bupivacaine will be injected for bilateral and bi-level ESPB application.

In the intraoperative period, intravenous meperidine 0.5 mg/kg will be given 30min before the end of surgery.
Procedure: Bi-level Erector Spinae Plane Block

Bi-level erector spinae plane block will be performed on the patients using a total of 40 ml of 0.25% bupivacaine under ultrasound guidance.

Additionally, in the postoperative period a dexketoprofen dose of 50 mg twice daily were administered iv for multimodal analgesia.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain Scores
Time Frame: On the operation day
Pain will be assessed at rest and while coughing using the visual analog scale on a scale from 0 (no pain) to 10 (worst pain). Pain assessment will be done at 0st, 1st, 2nd,4th, 12th, and 24th hours after surgery.
On the operation day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intraoperative opioid consumption
Time Frame: Intraoperative period
Remifentanil consumption for intraoperative period will be recorded
Intraoperative period
Postoperative Opioid Consumption
Time Frame: On the operation day
Opioid consumption for 24 hours will be recorded
On the operation day

Collaborators and Investigators

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

Sponsor

Ankara Etlik City Hospital

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)

August 18, 2025

Primary Completion (Estimated)

July 10, 2026

Study Completion (Estimated)

July 24, 2026

Study Registration Dates

First Submitted

August 8, 2025

First Submitted That Met QC Criteria

August 8, 2025

First Posted (Actual)

August 14, 2025

Study Record Updates

Last Update Posted (Actual)

August 19, 2025

Last Update Submitted That Met QC Criteria

August 18, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AEŞH-EK-2025-155

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 Liver Transplantation

Clinical Trials on Intrathecal Morphine

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Burundi

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe