NCT07617545

Brief Summary

This study aims to compare between ultrasound guided external oblique intercostal plane block and ultrasound guided erector spinae plane block in paediatric upper abdominal surgeries.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
3mo left

Started May 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 Progress79%
May 2025Oct 2026

Study Start

First participant enrolled

May 1, 2025

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

May 24, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 1, 2026

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2026

Last Updated

June 1, 2026

Status Verified

May 1, 2026

Enrollment Period

1.4 years

First QC Date

May 24, 2026

Last Update Submit

May 24, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Degree of pain

    Postoperative pain will be assessed using Faces pain score revised. The Faces Pain Scale revised (FPS-R) is a validated self-report instrument designed to measure pain intensity in pediatric populations. The scale comprises a series of facial expressions, ranging from a smiling face at 0, indicating "no pain," to a crying face at 10, indicating "very much pain". Children are instructed to select the face that most accurately reflects their current pain level. The faces are scored (0, 2, 4, 6, 8, 10), providing a quantifiable measure of pain intensity.

    12 hours after surgery

Secondary Outcomes (6)

  • Heart rate

    Every 15 minutes intraoperative

  • Mean arterial blood pressure

    Every 15 minutes intraoperative

  • Peripheral oxygen saturation

    Every 15 minutes intraoperative

  • Duration of analgesia

    12 hours after surgery

  • Total rescue analgesia requirement

    12 hours after surgery

  • +1 more secondary outcomes

Study Arms (2)

Group I

EXPERIMENTAL

Patients will receive ultrasound-guided external oblique intercostal plane block.

Other: External oblique intercostal plane block

Group II

EXPERIMENTAL

Patients will receive ultrasound-guided erector spinae plane block.

Other: Erector spinae plane block

Interventions

Patients will receive ultrasound-guided external oblique intercostal plane block.

Group I

Patients will receive ultrasound-guided erector spinae plane block.

Group II

Eligibility Criteria

Age6 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Children aged between 6 and 12 years of both sex.
  • Patients with the American Society of Anesthesiologists (ASA) physical status I/II.
  • Patients undergoing upper abdominal surgeries involving upper abdominal incisions.

You may not qualify if:

  • Guardian refusal.
  • Allergy to local anesthetics.
  • Surgical procedures exceeding 3 hours.
  • Infection at the area planned for the block injection.
  • Prolonged opioid medication.
  • Patients preoperatively medicated by Beta blockers

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Alexandria University

Alexandria, 21526, Egypt

RECRUITING

Central Study Contacts

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 Anaesthesia, Surgical Intensive Care and Pain Management, Alexandria University, Alexandria, Egypt.

Study Record Dates

First Submitted

May 24, 2026

First Posted

June 1, 2026

Study Start

May 1, 2025

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

October 1, 2026

Last Updated

June 1, 2026

Record last verified: 2026-05

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