NCT07618650

Brief Summary

This study aims to compare the effectiveness of ultrasound-guided Transversalis Fascia Plane block versus Quadratus Lumborum block for postoperative pain relief in pediatrics undergoing appendectomy. Primary outcomes:

  • Proportion of patients needing rescue analgesia within the first 24 postoperative hours. Secondary outcomes:
  • Visual Analogue Scale pain intensity measurements.
  • Intraoperative Heart rate and mean arterial blood pressure will be recorded.
  • Time to first analgesic request for patients needing rescue analgesia (Fentanyl).
  • Block-related complications (e.g., hematoma, local anesthetic toxicity, lower limb weakness).
  • Parents' satisfaction score.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2025

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

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

June 30, 2025

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 20, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 20, 2026

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

May 25, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 1, 2026

Completed
Last Updated

June 1, 2026

Status Verified

June 1, 2025

Enrollment Period

11 months

First QC Date

May 25, 2026

Last Update Submit

May 25, 2026

Conditions

Keywords

Transversalis Fascia Plane BlockQuadratus Lumborum Plane BlockAppendectomyPediatrics

Outcome Measures

Primary Outcomes (1)

  • Proportion of patients needing rescue analgesia

    within the first 24 postoperative hours.

Secondary Outcomes (1)

  • Visual Analogue Scale

    24 postoperative hours

Study Arms (2)

Group I: Transversalis Fascia Plane Block versus

EXPERIMENTAL

Patients will receive general anesthesia and ultrasound-guided transversalis fascia plane block in a dose of 0.4 ml/kg of 0.25% bupivacaine administered prior to surgical excision

Procedure: Transversalis Fascia Plane Block group

Group II :Quadratus Lumborum Plane Block

EXPERIMENTAL

patients will receive general anesthesia and a quadratus lumborum plane block in a dose of 0.4 ml/kg of 0.25% bupivacaine administered prior to surgical excision.

Procedure: Quadratus Lumborum Plane Block group

Interventions

35 Patients will receive general anesthesia and ultrasound-guided transversalis fascia plane block in a dose of 0.4 ml/kg of 0.25% bupivacaine administered prior to surgical excision.

Group I: Transversalis Fascia Plane Block versus

35 patients will receive general anesthesia and a quadratus lumborum plane block in a dose of 0.4 ml/kg of 0.25% bupivacaine administered prior to surgical excision

Group II :Quadratus Lumborum Plane Block

Eligibility Criteria

Age7 Years - 12 Years
Sexall(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • patients aged between 7 and 12 years of both sexes undergoing appendectomy, American Society of Anesthesiologists (ASA) physical status of I or II

You may not qualify if:

  • Refusal of parents to participate
  • Patients with peritonitis
  • History of allergy to bupivacaine and other amide local anesthetics
  • Infection at the site of block needle entry
  • Bleeding diathesis
  • Neurological disorders
  • American Society of Anesthesiologists ≥ III

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tanta University

Tanta, Egypt

Location

Study Design

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

Study Record Dates

First Submitted

May 25, 2026

First Posted

June 1, 2026

Study Start

June 30, 2025

Primary Completion

May 20, 2026

Study Completion

May 20, 2026

Last Updated

June 1, 2026

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will share

It will be available if it needed

Shared Documents
STUDY PROTOCOL, SAP, ICF

Locations