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

NCT07123740 | Recruiting

• 1 other identifier: AEŞH-EK-2025-155
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Liver Transplantation; Pain Management

Keywords

Liver Transplantation; Intrathecal Morphine; Erector Spinae Plane Block

Outcome Measures

Primary Outcomes (1)

• Pain Scores

  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 Outcomes (2)

• Intraoperative opioid consumption

  Intraoperative period

• Postoperative Opioid Consumption

  On the operation day

Study Arms (2)

Intrathecal Morphine

ACTIVE COMPARATOR

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

Bi-level Erector Spinae Plane Block

ACTIVE COMPARATOR

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 Next, the needle will be withdrawn till subcutaneously and the linear US probe will be placed 2-3 cm lateral to the T10 spinous process.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

Interventions

Intrathecal Morphine PROCEDURE

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.

Intrathecal Morphine

Bi-level Erector Spinae Plane Block PROCEDURE

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.

Bi-level Erector Spinae Plane Block

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ankara Etlik City Hospital: lead

Study Sites (1)

Ankara Etlik City Hospital

Altındağ, Ankara, 06000, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Atakan Sezgi

CONTACT

00905323327000; kansezgi@gmail.com

Jülide Ergil

CONTACT

00905323469216; julideergil@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 8, 2025
• First Posted: August 14, 2025
• Study Start: August 18, 2025
• Primary Completion (Estimated): July 10, 2026
• Study Completion (Estimated): July 24, 2026
• Last Updated: August 19, 2025

Record last verified: 2025-08

Locations

TU (1)