NCT07850596

Brief Summary

The aim of this study is to compare the analgesic efficacy and safety of Quadratus Lumborum (QL), Transversus Abdominis Plane (TAP), and Erector Spinae Plane (ESP) blocks in pediatric abdominal surgery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2025

Geographic Reach
1 country

1 active site

Status
completed

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

January 1, 2025

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2026

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 23, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 30, 2026

Completed
Last Updated

September 30, 2026

Status Verified

September 1, 2026

Enrollment Period

1.4 years

First QC Date

September 23, 2026

Last Update Submit

September 23, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Degree of pain

    Degree of pain will be assessed using Wong-Baker FACES for the first 24 hours postoperative at 4, 8,12,16 and 24 hours postoperatively. Wong-Baker FACES Pain Scale, which utilizes a series of 6 faces increasing in pain severity may be used to facilitate communication and assist in pain assessment .

    24 hours postoperatively

Secondary Outcomes (8)

  • Total fentanyl consumption

    Intraoperatively

  • Heart rate

    Till the end of surgery (Up to 2 hours)

  • Mean arterial blood pressure

    Till the end of surgery (Up to 2 hours)

  • Time of each block

    Intraoperatively

  • Sedation score

    24 hours postoperatively

  • +3 more secondary outcomes

Study Arms (3)

QL Group

EXPERIMENTAL

Patients received quadratus lumborum (QL) block with bupivacaine 0.25% (0.5 ml/kg) + dexmedetomidine 0.5 mcg/kg.

Drug: Quadratus lumborum (QL) block

TAP group

EXPERIMENTAL

Patients received transversus abdominis plane (TAP) block with bupivacaine 0.25% (0.5 ml/kg) + dexmedetomidine 0.5 mcg/kg

Drug: Transversus abdominis plane (TAP) block

ES Group

EXPERIMENTAL

Patients received erector spinae plane (ESP) block with bupivacaine 0.25% (0.5 ml/kg) + dexmedetomidine 0.5 mcg/kg.

Drug: Erector spinae plane (ESP) block

Interventions

Patients received quadratus lumborum (QL) block with bupivacaine 0.25% (0.5 ml/kg) + dexmedetomidine 0.5 mcg/kg.

Also known as: Bupivacaine 0.25% (0.5 ml/kg) + dexmedetomidine 0.5 mcg/kg
QL Group

Patients received transversus abdominis plane (TAP) block with bupivacaine 0.25% (0.5 ml/kg) + dexmedetomidine 0.5 mcg/kg.

Also known as: Bupivacaine 0.25% (0.5 ml/kg) + dexmedetomidine 0.5 mcg/kg
TAP group

Patients received erector spinae plane (ESP) block with bupivacaine 0.25% (0.5 ml/kg) + dexmedetomidine 0.5 mcg/kg.

Also known as: Bupivacaine 0.25% (0.5 ml/kg) + dexmedetomidine 0.5 mcg/kg
ES Group

Eligibility Criteria

Age3 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Children aged from 3 to12 years.
  • Both sexes.
  • American Society of Anesthesiologists (ASA) Physical Status I-II.
  • Scheduled for pediatric abdominal surgery.

You may not qualify if:

  • Allergy or contraindication to bupivacaine or dexmedetomidine.
  • Coagulopathy.
  • Local infection at the site of the block.
  • Neurological or psychiatric disorders affecting pain perception.
  • Refusal of the regional technique by parents/guardians.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Menoufia University

Shibīn al Kawm, Menoufia, 32951, Egypt

Location

MeSH Terms

Interventions

Dental OcclusionBupivacaineDexmedetomidineParapsychology

Intervention Hierarchy (Ancestors)

DentistryDental Physiological PhenomenaDigestive System and Oral Physiological PhenomenaAnilidesAmidesOrganic ChemicalsAniline CompoundsAminesImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsBehavioral SciencesBehavioral Disciplines and Activities

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
Assistant Lecturer of Anesthesia, ICU and Pain Management, Faculty of Medicine, Menoufia University, Egypt.

Study Record Dates

First Submitted

September 23, 2026

First Posted

September 30, 2026

Study Start

January 1, 2025

Primary Completion

June 1, 2026

Study Completion

June 1, 2026

Last Updated

September 30, 2026

Record last verified: 2026-09

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