NCT07502833

Brief Summary

This study aims to evaluate whether an ultrasound-guided recto-intercostal fascial plane block performed before surgical incision in patients undergoing laparoscopic cholecystectomy reduces intraoperative opioid and volatile anesthetic consumption. Additionally, the study assesses its effects on postoperative pain and the incidence of nausea and vomiting.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2026

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 3, 2026

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 15, 2026

Completed
5 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 20, 2026

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2026

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 31, 2026

Completed
Last Updated

March 31, 2026

Status Verified

March 1, 2026

Enrollment Period

3 months

First QC Date

March 15, 2026

Last Update Submit

March 30, 2026

Conditions

Pain ManagementRecto Intercostal Nerve Block

Keywords

cholecystektomyrectointercostal facial plane blockopioid consumptionpostoperative pain

Outcome Measures

Primary Outcomes (1)

  • Intraoperative volatile anesthetic consumption

    Total intraoperative volatile anesthetic consumption per patient, measured in milliliters (mL).

    During surgery (up to 3 hours)

Secondary Outcomes (1)

  • Intraoperative opioid consumption

    During surgery (up to 3 hours)

Study Arms (2)

block group

ACTIVE COMPARATOR

block group bilateral 30 mlbupivacaine 0.25%

Procedure: Procedure: Recto-intercostal fascial plane block

control group

NO INTERVENTION

Interventions

Procedure: Recto-intercostal fascial plane blockPROCEDURE

A total of 30 mL of 0.25% bupivacaine is administered bilaterally under ultrasound guidance into the recto-intercostal fascial plane prior to surgical incision.

block group

Eligibility Criteria

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

You may qualify if:

  • Adult patients aged 18-65 years
  • Scheduled for elective laparoscopic cholecystectomy
  • American Society of Anesthesiologists (ASA) physical status I-III
  • Ability to provide written informed consent

You may not qualify if:

  • Refusal to participate
  • Known allergy to local anesthetics
  • Coagulopathy or anticoagulant therapy
  • Infection at the injection site
  • Body weight less than 75 kg
  • Severe hepatic or renal dysfunction
  • Pregnancy or breastfeeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Etlik City Hospital

Ankara, Türkiye, 06170, Turkey (Türkiye)

RECRUITING

Related Publications (2)

  • Rehab OM, Bakr DM, El Malla DA, Helal RAEF, Morsy I, Eloraby M. The analgesic effects of ultrasound-guided recto-intercostal fascial plane block in laparoscopic hiatus hernia repair: A randomized double-blind controlled study. Anaesth Crit Care Pain Med. 2025 Dec 3;45(3):101724. doi: 10.1016/j.accpm.2025.101724. Online ahead of print.

    PMID: 41349840BACKGROUND

  • Tulgar S, Ciftci B, Ahiskalioglu A, Bilal B, Alver S, Sakul BU, Ansen G, Pence KB, Alici HA. Recto-intercostal fascial plane block: Another novel fascial plane block. J Clin Anesth. 2023 Oct;89:111163. doi: 10.1016/j.jclinane.2023.111163. Epub 2023 Jun 7. No abstract available.

    PMID: 37295124BACKGROUND

MeSH Terms

Conditions

AgnosiaPain, Postoperative

Condition Hierarchy (Ancestors)

Perceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsPostoperative ComplicationsPathologic ProcessesPain

Central Study Contacts

Oya Kale, specialist anesthesiology

CONTACT

+90 0506 408 21 70oyakale@yahoo.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
The block procedure is performed after induction of general anesthesia, and participants are unaware of group allocation. Postoperative outcome assessment is conducted by an investigator who is blinded to group assignment.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
specialist anesthesia

Study Record Dates

First Submitted

March 15, 2026

First Posted

March 31, 2026

Study Start

January 3, 2026

Primary Completion

March 20, 2026

Study Completion

March 30, 2026

Last Updated

March 31, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Individual participant data (IPD) will not be shared. All data will be de-identified to protect participant confidentiality and will be accessible only to the study investigators.

Locations

TU(1)