NCT07233096

Brief Summary

Postoperative pain control plays a crucial role in enhancing recovery and improving early mobilization in living liver donors. The rectus-intercostal fascial plane (RIFP) block is a novel ultrasound-guided regional anesthesia technique that provides anterior abdominal wall analgesia by targeting the intercostal nerves between the rectus abdominis and intercostal muscle fascia. This prospective, randomized controlled clinical study aims to evaluate the postoperative analgesic efficacy and opioid-sparing effects of the RIFP block compared with standard intravenous analgesia in living liver donors undergoing donor hepatectomy. Participants will be randomly assigned to two groups: Group 1 (RIFP Block): Patients receiving an ultrasound-guided rectus-intercostal fascial plane block using 20 mL of 0.25% bupivacaine at the end of surgery, in addition to standard IV PCA (morphine). Group 2 (Control): Patients receiving only standard IV PCA (morphine) without regional block.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
0mo left

Started Dec 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress85%
Dec 2025Jun 2026

First Submitted

Initial submission to the registry

November 14, 2025

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 18, 2025

Completed
1 month until next milestone

Study Start

First participant enrolled

December 22, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2026

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2026

Expected
Last Updated

January 8, 2026

Status Verified

November 1, 2025

Enrollment Period

4 months

First QC Date

November 14, 2025

Last Update Submit

January 6, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Morphine consumption

    The amount of morphine required by the patient and given by the device will be recorded for the first 24 hours.

    Postoperative 24 hours

Secondary Outcomes (3)

  • Postoperative visual analog scale scores

    Postoperative 24 hours

  • Rescue analgesic drug consumption

    postoperative 24 hours

  • Incidence of postoperative nausea and vomiting

    postoperative 24 hours

Study Arms (2)

Rectus Intercostal Plane Block Group

ACTIVE COMPARATOR

Rectus Intercostal Plane Block Group The patients in the Rectus Intercostal Plane Block group will receive a bilateral rectus intercostal plane block and patient-controlled analgesia (PCA) with morphine for postoperative analgesia.

Other: Rectus Intercostal Plane Block

Control Group

ACTIVE COMPARATOR

The patients in the Control group will not receive any regional block and will receive PCA with morphine for postoperative analgesia.

Other: Control (No Block)

Interventions

Rectus intercostal plane block will be administered bilaterally at the end of the surgery and after skin closure under ultrasound guidance

Rectus Intercostal Plane Block Group

Ultrasound probe placement on the same region without needle insertion or local anesthetic injection to maintain blinding.

Control Group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age between 18 and 75 years
  • Patients with American Society of Anesthesiology (ASA) physical status I-II
  • Patients scheduled for a living donor hepatectomy

You may not qualify if:

  • Allergy to local anesthetics
  • Coagulopathy
  • Skin infection at the block area
  • Advanced renal failure
  • Chronic pain syndromes
  • Alcohol or drug abuse
  • Psychiatric disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

istinye University

Istanbul, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 14, 2025

First Posted

November 18, 2025

Study Start

December 22, 2025

Primary Completion

May 1, 2026

Study Completion (Estimated)

June 1, 2026

Last Updated

January 8, 2026

Record last verified: 2025-11

Locations