NCT07615231

Brief Summary

This study aims to compare the analgesic efficacy of two different ultrasound-guided nerve blocks-the External Oblique Intercostal (EOI) block and the Subcostal Transversus Abdominis Plane (TAP) block-in patients undergoing minimally invasive hepatectomy. All participants will receive standardized general anesthesia and perioperative care at Seoul National University Hospital. Following anesthesia induction, patients will be randomly assigned to receive either an EOI block or a subcostal TAP block with 0.375% ropivacaine to provide regional pain relief. Postoperative pain will be managed using a combination of scheduled non-opioid analgesics and a fentanyl-based patient-controlled analgesia (PCA) device. The primary objective is to evaluate which regional technique more effectively reduces cumulative opioid consumption during the first 24 hours after surgery. Additionally, the study will assess pain intensity using the Numerical Rating Scale (NRS), the incidence of postoperative nausea and vomiting, and the overall recovery profile, including the time to first ambulation.

Trial Health

63
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Trial Health Score

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

Enrollment
140

participants targeted

Target at P50-P75 for not_applicable

Timeline
13mo left

Started Jun 2026

Geographic Reach
1 country

1 active site

Status
not yet 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 Progress4%
Jun 2026Jun 2027

First Submitted

Initial submission to the registry

May 22, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 29, 2026

Completed
3 days until next milestone

Study Start

First participant enrolled

June 1, 2026

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2027

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2027

Last Updated

June 8, 2026

Status Verified

June 1, 2026

Enrollment Period

12 months

First QC Date

May 22, 2026

Last Update Submit

June 4, 2026

Conditions

Keywords

minimally invasive hepatectomyTAP blockEOI block

Outcome Measures

Primary Outcomes (1)

  • Cumulative opioid consumption at 24 hours postoperatively

    The total amount of intravenous fentanyl administered via patient-controlled analgesia (PCA) and as rescue boluses will be recorded and converted to intravenous morphine equivalents for standardized comparison.

    From the end of surgery up to 24 hours postoperatively

Secondary Outcomes (5)

  • Cumulative Opioid Consumption at 1, 6, 12, and 48 hours postoperatively

    1, 6, 12, and 48 hours after surgery completion.

  • Postoperative pain intensity measured by Numerical Rating Scale (NRS)

    During Post-Anesthesia Care Unit (PACU) stay, and at 24 and 48 hours postoperatively.

  • Total dose of intraoperative remifentanil

    During the intraoperative period (from induction to skin closure).

  • Incidence of Postoperative Nausea and Vomiting

    Up to 48 hours postoperatively.

  • Time to first ambulation

    From the end of surgery up to 48 hours postoperatively (or until the first occurrence).

Study Arms (2)

External Oblique Intercostal (EOI) block group

EXPERIMENTAL

patients who receive EOI block

Procedure: External Oblique Intercostal Block

Transversus Abdominis Plane (TAP) block group

ACTIVE COMPARATOR

Patients who receive TAP block

Procedure: TAP Block

Interventions

Following the induction of general anesthesia, patients in this group will receive an ultrasound-guided bilateral external intercostal fascial plane block. A total of 40 mL of 0.375% ropivacaine (20 mL per side) will be injected into the plane between the external intercostal muscle and the internal intercostal muscle at the T6-7 or T7-8 level.

External Oblique Intercostal (EOI) block group
TAP BlockPROCEDURE

Following the induction of general anesthesia, patients in this group will receive an ultrasound-guided bilateral subcostal transversus abdominis plane block. A total of 40 mL of 0.375% ropivacaine (20 mL per side) will be injected into the fascial plane between the internal oblique and transversus abdominis muscles along the subcostal margin.

Transversus Abdominis Plane (TAP) block group

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Scheduled to undergo elective robotic or laparoscopic minimally invasive hepatectomy

You may not qualify if:

  • American Society of Anesthesiologists physical status IV or higher
  • History of chronic pain or current use of analgesics, antidepressants, or anticonvulsants for pain management
  • Known hypersensitivity to general anesthetics, opioids, or local anesthetics
  • Conversion to open hepatectomy
  • Requirement for mechanical ventilation for more than 2 hours within 48 hours postoperatively
  • Any other clinical condition that makes the patient unsuitable for participation in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SNUH

Seoul, 03080, South Korea

Location

Study Officials

  • Hyun-Kyu Yoon, MD/PhD

    Seoul National University Hospital

    STUDY CHAIR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Associate Professor

Study Record Dates

First Submitted

May 22, 2026

First Posted

May 29, 2026

Study Start

June 1, 2026

Primary Completion (Estimated)

May 31, 2027

Study Completion (Estimated)

June 30, 2027

Last Updated

June 8, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Deidentified individual participant data and a data dictionary will be made available to researchers for specified analyses upon reasonable request to the corresponding author via email.

Locations