NCT07547280

Brief Summary

The primary aim of this study was to investigate the effects of the external oblique intercostal plane block and the subcostal transversus abdominis plane block on postoperative pain scores and opioid consumption in patients undergoing laparoscopic sleeve gastrectomy.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
12mo left

Started Apr 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 Progress9%
Apr 2026May 2027

First Submitted

Initial submission to the registry

March 25, 2026

Completed
7 days until next milestone

Study Start

First participant enrolled

April 1, 2026

Completed
22 days until next milestone

First Posted

Study publicly available on registry

April 23, 2026

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2027

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2027

Last Updated

April 23, 2026

Status Verified

April 1, 2026

Enrollment Period

1 year

First QC Date

March 25, 2026

Last Update Submit

April 20, 2026

Conditions

Sleeve GastrectomyExternal Oblique Intercostal Plane BlockSubcostal Transverse Abdominis Plane Block

Keywords

Ultrasound guided · External oblique intercostal plane block · Sleeve gastrectomy Bariatric surgery Postoperative · Analgesia

Outcome Measures

Primary Outcomes (1)

  • Postoperative Acute Pain Scores

    Postoperative acute pain scores assingment with Visual Analog Scores

    postoperative T1: 0. hours, T2:4.hours,T3:12.hours,T4: 24.hours

Secondary Outcomes (3)

  • Total Opioid Consumption

    POSTOPERATİVE T1:0 HOURS T2:4. HOURS T3:12.HOURS T4:24.HOURS

  • PATIENT SATISFACTION (Likert Scale) Not satisfied at all 1 Slightly satisfied 2 Moderately satisfied3 Satisfied4 Excellent5 SURGEON SATISFACTION (Likert Scale) Not satisfied at all 1 Slightly satisfied 2 Moderately satisfied3 Satisfied4 Excellent5

    Postoperative 24.hours

  • Postoperative Nause and Vomiting

    Postoperative first 24.hours

Study Arms (3)

External Oblique Intercostal Block

EXPERIMENTAL

patient receive block that External Oblique Intercostal Blcok

Procedure: Ultrasound-guided external oblique intercostal plane block

Subcostal Transversus Abdominis Plane Block (s-TAP)

EXPERIMENTAL

Patient receive that OSTAP

Procedure: Subcostal Transversus Abdominis Plane Block (s-TAP)

Local anesthetic infiltration

EXPERIMENTAL

Surgeon implement local anesthetic to port site

Procedure: Local anesthetic infiltration

Interventions

Ultrasound-guided external oblique intercostal plane blockPROCEDURE

Ultrasound-guided external oblique intercostal plane block will be performed at the T6 level using 20 ml of 0.25% bupivacaine at the Immediately after intubation

External Oblique Intercostal Block
Local anesthetic infiltrationPROCEDURE

Port-site local anesthetic infiltration will be performed with bupivacain after intubation by surgeon.

Local anesthetic infiltration
Subcostal Transversus Abdominis Plane Block (s-TAP)PROCEDURE

Ultrasound-guided OSTAP block will be performed using 20 ml of 0.25% bupivacaine immediately after intubation.

Subcostal Transversus Abdominis Plane Block (s-TAP)

Eligibility Criteria

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

You may qualify if:

  • Adult patients aged between 18 and 65 years
  • Patients classified as American Society of Anesthesiologists (ASA) physical status I-III

You may not qualify if:

  • Patients younger than 18 years or older than 65 years
  • Inability to cooperate or comply with study procedures
  • Liver and kidney failure
  • American Society of Anesthesiologists (ASA) IV-V patient
  • External oblique intercostal block(EOİB) and the Subcostal Transversus Abdominis Plane block(s-TAB) are contraindicated

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sanliurfa Education and Research Hospital

Sanliurfa, Şanlıurfa, 63200, Turkey (Türkiye)

Location

Study Officials

  • Melike Bostancı Erkmen, M.D.

    Sanliurfa Education and Research Hospital

    PRINCIPAL INVESTIGATOR

  • Tolga Karaçay, M.D.

    Sanliurfa Education and Research Hospital

    PRINCIPAL INVESTIGATOR

  • Servet Sürmeli, M.D.

    Sanliurfa Education and Research Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

MELİKE BOSTANCI ERKMEN, MD

CONTACT

+905355708530mlkbstnci@gmail.com

Tolga Karaçay, MD

CONTACT

+905458718351tkaracay35@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Specialist

Study Record Dates

First Submitted

March 25, 2026

First Posted

April 23, 2026

Study Start

April 1, 2026

Primary Completion (Estimated)

April 1, 2027

Study Completion (Estimated)

May 1, 2027

Last Updated

April 23, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

No Ethics committee approval covers only aggregate data analysis; there is no permission to share individual participant data.

Locations

TU(1)