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

NCT ID: NCT07123740

Last Updated: 2025-08-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-08-18

Study Completion Date

2026-07-24

Brief Summary

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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.

Detailed Description

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Conditions

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Liver Transplantation Pain Management

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Intrathecal Morphine

Intervention Type 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.

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.

Group Type ACTIVE_COMPARATOR

Bi-level Erector Spinae Plane Block

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ankara Etlik City Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Atakan Sezgi

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Ankara Etlik City Hospital

Altındağ, Ankara, Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Atakan Sezgi

Role: CONTACT

00905323327000

Jülide Ergil

Role: CONTACT

00905323469216

Facility Contacts

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Atakan Sezgi, M.D.

Role: primary

00905323327000

Jülide Ergil, Professor

Role: backup

00905323469216

Other Identifiers

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AEŞH-EK-2025-155

Identifier Type: -

Identifier Source: org_study_id

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