NCT07301528

Brief Summary

This prospective randomized controlled clinical trial aims to compare the analgesic effectiveness of the Erector Spinae Plane (ESP) block and the Quadratus Lumborum (QL) block in pediatric patients undergoing appendectomy. Both regional anesthesia techniques have been shown to reduce opioid requirements and improve postoperative recovery in children; however, there is limited evidence directly comparing their efficacy. In this study, eligible participants will be randomly assigned to receive either an ESP or a QL block in addition to standard general anesthesia before surgical incision. Postoperative outcomes will include pain scores, total opioid consumption, time to first analgesic requirement, mobilization time, parental satisfaction, length of hospital stay, block-related complications and block performance time. The findings are expected to guide clinicians in selecting the most effective regional anesthesia technique for postoperative pain control in pediatric appendectomy.

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 Dec 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

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

First Submitted

Initial submission to the registry

November 16, 2025

Completed
27 days until next milestone

Study Start

First participant enrolled

December 13, 2025

Completed
11 days until next milestone

First Posted

Study publicly available on registry

December 24, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2026

Completed
13 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 28, 2026

Completed
Last Updated

May 5, 2026

Status Verified

April 1, 2026

Enrollment Period

4 months

First QC Date

November 16, 2025

Last Update Submit

April 29, 2026

Conditions

Keywords

Erector Spinae Plane BlockQuadratus Lumborum BlockRegional AnesthesiaPediatric AppendectomyPostoperative PainUltrasound-Guided Nerve BlocksAnalgesic Requirement

Outcome Measures

Primary Outcomes (1)

  • Postoperative Pain Score

    Pain intensity will be evaluated at rest using the Oucher Pain Rating Scale. Higher scores indicate greater pain.

    Pain scores will be assessed at 1, 6, 12, and 24 postoperative hours.

Secondary Outcomes (7)

  • Total Analgesic Consumption

    Recorded during the first 24 hours after surgery

  • Time to First Analgesic Requirement

    From the end of surgery until the first documented analgesic requirement, assessed up to 24 hours postoperatively

  • Time to Mobilization

    From the end of surgery until the first successful ambulation with or without assistance, assessed up to 24 hours postoperatively

  • Length of Hospital Stay

    From the end of surgery until hospital discharge, typically within 24-48 hours.

  • Parents' Postoperative Pain Measure (PPPM)

    Assessed at 1, 6, 12, and 24 hours postoperatively

  • +2 more secondary outcomes

Study Arms (2)

QLB Block

EXPERIMENTAL

Ultrasound-guided transmuscular QL block using 0.25% bupivacaine (0.5 mL/kg) before surgical incision.

Drug: Quadratus Lumborum Block (QLB)

ESP Block

ACTIVE COMPARATOR

Ultrasound-guided ESP block at the L1 level using 0.25% bupivacaine (0.5 mL/kg) before surgical incision.

Drug: Erector Spinae Plane Block

Interventions

Ultrasound-guided transmuscular QL block performed under general anesthesia using 0.25% bupivacaine (0.5 mL/kg) before surgical incision.

QLB Block

Ultrasound-guided ESP block at the L1 level under general anesthesia using 0.25% bupivacaine (0.5 mL/kg) before surgical incision.

ESP Block

Eligibility Criteria

Age3 Years - 13 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Patients aged 3-13 years
  • Diagnosis of acute appendicitis requiring appendectomy
  • ASA physical status I-II
  • Planned general anesthesia with intraoperative regional block (ESP or QL block)
  • Written informed consent obtained from parents or legal guardians

You may not qualify if:

  • Refusal of regional block by family or anesthesia team
  • Coagulopathy or anticoagulant medication use
  • Local infection at the block injection site
  • Known allergy or contraindication to local anesthetics
  • Neurological or neuromuscular disorders
  • Cognitive impairment preventing postoperative pain assessment
  • Conversion to open surgery
  • Intraoperative complications requiring deviation from study protocol

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Kutahya City Hospital Anesthesia and Reanimation Department

Kütahya, Kütahya, 43100, Turkey (Türkiye)

Location

Kutahya City Hospital

Kütahya, 43100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Süleyman Camgöz

    Kutahya Health Sciences University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Participants will be randomly assigned in a 1:1 ratio to one of two parallel intervention arms: ultrasound-guided Erector Spinae Plane block or ultrasound-guided Quadratus Lumborum block, both performed under general anesthesia before surgical incision.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Medicine of Doctor

Study Record Dates

First Submitted

November 16, 2025

First Posted

December 24, 2025

Study Start

December 13, 2025

Primary Completion

April 15, 2026

Study Completion

April 28, 2026

Last Updated

May 5, 2026

Record last verified: 2026-04

Locations