NCT07252063

Brief Summary

Living liver donor hepatectomy at our institution routinely includes ultrasound-guided interfascial plane blocks as part of postoperative analgesia. Although these blocks have become increasingly used in donor hepatectomy, their cutaneous sensory distributions and block-related dermatomal coverage have not been systematically evaluated, with only anecdotal reports available in the literature. This prospective observational study aims to assess both the sensory blockade patterns and the early postoperative analgesic performance of interfascial plane blocks administered to living liver donors. Following surgery, all consenting donors receive the institution's standard block protocol. Cutaneous sensory mapping is performed in the post-anesthesia care unit (PACU) at the second postoperative hour. Pain intensity and analgesic requirements within the first 24 hours are also recorded. The study is designed to provide objective data on the dermatomal coverage and postoperative analgesic effects of contemporary ultrasound-guided interfascial plane blocks used in living liver donor surgery.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2025

Shorter than P25 for all trials

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 Start

First participant enrolled

November 1, 2025

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

November 19, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 26, 2025

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2026

Completed
Last Updated

November 26, 2025

Status Verified

November 1, 2025

Enrollment Period

2 months

First QC Date

November 19, 2025

Last Update Submit

November 19, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Cutaneous sensory block area mapping for different regional anesthesia techniques in liver donor surgery

    The cutaneous sensory block area produced by the regional anesthesia technique will be evaluated at the 120th minute post-block using a standardized pinprick test. Sensory borders will be identified radially and marked on the skin with a UV-visible marker. Each mapped region will be photographed with a calibrated reference scale placed on the skin. These images will be processed using a predefined digital template to calculate the total blocked surface area in square centimeters. The resulting measurements will be used to characterize the sensory distribution of the interfascial plane blocks in living liver donors.

    At 120 minutes after block administration in the post-anesthesia care unit (PACU).

Interventions

Ultrasound-guided interfascial plane blocks are administered at the end of surgery. Block selection and needle entry points are determined according to the surgical incision line and the location of abdominal drains. All blocks are performed under real-time ultrasound guidance using the institution's standardized protocol.

Intravenous patient-controlled analgesia is initiated in the postoperative period according to the institution's standard protocol. PCA settings, opioid type, basal infusion (if applicable), and bolus doses follow routine clinical practice and are recorded for analysis. PCA use during the first 24 hours is monitored to assess postoperative analgesic requirements.

Cutaneous sensory mapping is performed in the post-anesthesia care unit (PACU) at the second postoperative hour. Sensory blockade is assessed using a standardized pinprick test applied radially from medial to lateral directions. The borders of the blocked and unblocked regions are marked on the skin using a UV-visible dermatographic pen. Mapping is conducted over the mid-abdominal and lateral abdominal regions, and the total cutaneous coverage areas are subsequently calculated for analysis.

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study population consists of adult living liver donors undergoing elective donor hepatectomy at a tertiary care center. All participants receive ultrasound-guided interfascial plane blocks as part of the institution's routine postoperative analgesia protocol. Eligible donors are aged 18 to 65 years, classified as ASA physical status I-II, and able to cooperate with postoperative cutaneous sensory mapping procedures. Individuals with contraindications to regional anesthesia, conditions preventing accurate sensory assessment, or those who decline participation are excluded.

You may qualify if:

  • Adult living liver donors undergoing elective donor hepatectomy
  • Age 18 to 65 years
  • ASA physical status I-II
  • Patients who have received ultrasound-guided interfascial plane blocks as part of their postoperative analgesia
  • Ability to cooperate with postoperative sensory mapping procedures
  • Patients who agree to participate and provide written informed consent

You may not qualify if:

  • Patients who refuse to participate or do not provide written informed consent
  • Patients who have not received any ultrasound-guided interfascial plane block
  • ASA physical status \> II
  • Presence of surgical incisions or wound complications preventing reliable sensory mapping
  • Prior major abdominal surgery that may alter cutaneous innervation patterns
  • Cognitive impairment limiting the ability to cooperate with sensory testing
  • Known psychiatric disorders (e.g., major depression, mania, schizophrenia) that may interfere with postoperative assessment
  • Local infection, skin disease, or dermatologic condition preventing accurate cutaneous mapping
  • Allergy or contraindication to local anesthetics used in the block

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bahcesehir Unişversity Medicalpark Goztepe hospital

Istanbul, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Department of Anesthesiology

Study Record Dates

First Submitted

November 19, 2025

First Posted

November 26, 2025

Study Start

November 1, 2025

Primary Completion

December 31, 2025

Study Completion

January 1, 2026

Last Updated

November 26, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations