NCT07366138

Brief Summary

This study aims to compare the analgesic efficacy, duration of analgesia, and overall opioid consumption between the external oblique intercostal plane (EOIP) block and subcostal transversus abdominis plane (TAP) block in patients undergoing laparoscopic sleeve gastrectomy.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
6mo left

Started Nov 2025

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 Progress51%
Nov 2025Nov 2026

Study Start

First participant enrolled

November 1, 2025

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 17, 2026

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 26, 2026

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2026

Last Updated

January 26, 2026

Status Verified

January 1, 2026

Enrollment Period

1 year

First QC Date

January 17, 2026

Last Update Submit

January 17, 2026

Conditions

Subcostal Transversus Abdominis Plane BlockPerioperative AnalgesiaLaparoscopic Sleeve GastrectomyUltrasoundExternal Oblique Intercostal Plane Block

Outcome Measures

Primary Outcomes (1)

  • Total morphine consumption

    Patient-controlled analgesia (PCA) using intravenous morphine (1 mg bolus, 10-minute lockout) will be available for rescue analgesia when visual analogue score ( VAS ) \> 3.

    24 hours postoperatively

Secondary Outcomes (7)

  • Time to first rescue analgesia

    24 hours postoperatively

  • Degree of pain

    24 hours postoperatively

  • Heart rate

    Till the end of surgery (Up to two hours)

  • Mean arterial blood pressure

    Till the end of surgery (Up to two hours)

  • Incidence of postoperative nausea and vomiting

    24 hours postoperatively

  • +2 more secondary outcomes

Study Arms (2)

EOIP Group (Group A )

EXPERIMENTAL

Patients will receive an ultrasound-guided bilateral external oblique intercostal plane (EOIP) block using 20 mL of 0.25% bupivacaine in each side after induction of anesthesia and prior to surgical incision.

Other: External oblique intercostal plane block

Subcostal TAP Group (Group T)

EXPERIMENTAL

Patients will receive a bilateral subcostal transversus abdominis plane (TAP) block using 20 mL of 0.25% bupivacaine in each side, under ultrasound guidance and identical conditions.

Other: Subcostal transversus abdominis plane block

Interventions

External oblique intercostal plane blockOTHER

Patients will receive an ultrasound-guided bilateral external oblique intercostal plane (EOIP) block using 20 mL of 0.25% bupivacaine in each side after induction of anesthesia and prior to surgical incision.

EOIP Group (Group A )
Subcostal transversus abdominis plane blockOTHER

Patients will receive a bilateral subcostal transversus abdominis plane (TAP) block using 20 mL of 0.25% bupivacaine in each side, under ultrasound guidance and identical conditions.

Subcostal TAP Group (Group T)

Eligibility Criteria

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

You may qualify if:

  • Age from 18 to 65 years.
  • Both genders.
  • American Society of Anesthesiologists (ASA) class I or II
  • Body mass index (BMI) between 30-50 kg/m².
  • Scheduled for elective laparoscopic sleeve gastrectomy under general anesthesia.
  • Written informed consent from patients or surrogate decision makers.

You may not qualify if:

  • Patient refusal.
  • Allergy to local anesthetics.
  • Coagulation disorders or anticoagulant therapy.
  • Local infection or scar at the injection site.
  • Severe hepatic or renal dysfunction.
  • Chronic opioid use or psychiatric illness interfering with pain assessment.
  • Conversion to open surgery or intraoperative complications requiring re-exploration.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Benha University

Banhā, Benha, 13518, Egypt

RECRUITING

Central Study Contacts

Ahmed A Ali, MBBCH

CONTACT

00201067850909macisosevo@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
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident of Anesthesiology, Egypt.

Study Record Dates

First Submitted

January 17, 2026

First Posted

January 26, 2026

Study Start

November 1, 2025

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

November 1, 2026

Last Updated

January 26, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will share

The data will be available upon a reasonable request from the corresponding author after the end of study for one year.

Shared Documents
STUDY PROTOCOL
Time Frame
After the end of study for one year.
Access Criteria
The data will be available upon a reasonable request from the corresponding author.

Locations

EG(1)