Comparison of the Analgesic Efficacy of Transversalis Fascia Plane Block and Posterior Quadratus Lumborum Block in Pediatric Patient Undergoing Orchiopexy: A Prospective Observational Study

December 25, 2025 updated by: Reyhan Kucuk Erturk, Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization

Comparison of the Analgesic Efficacy of Posterior Quadratus Lumborum Block and Transversalis Fascia Plane Block in Children Undergoing Orchiopexy

It was planned to compare the analgesic efficacy of the transversalis fascia plane block and the posterior quadratus lumborum block in children aged 1 to 7 years undergoing orchiopexy, by evaluating their FLACC scores and the time to first postoperative analgesic requirement.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

54

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey (Türkiye)
    • Şişli
      • Istanbul, Şişli, Turkey (Türkiye), 34384
        • Prof. Dr. Cemil Taşçıoğlu Şehir Hastanesi

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Children aged 1 to 7 years with ASA physical status I-II undergoing unilateral orchiopexy surgery.

Description

Inclusion Criteria:

  • Children aged 1 to 7 years with ASA physical status I-II undergoing unilateral orchiopexy surgery.

Exclusion Criteria:

  • ASA physical status ≥ III
  • History of prematurity (gestational age < 37 weeks) Known coagulation disorders or bleeding tendency
  • Infection, inflammation, or skin lesion at the injection site
  • Known neurological or neuromuscular diseases
  • Presence of significant cardiac or pulmonary disease (e.g., congenital heart disease, active asthma)
  • Hepatic or renal dysfunction
  • Known allergy or hypersensitivity to local anesthetics (e.g., bupivacaine, lidocaine)
  • Developmental delay or cognitive impairment that prevents accurate pain assessment
  • Use of additional regional analgesia techniques (e.g., caudal block) during surgery
  • Block failure or intraoperative complications requiring exclusion from protocol analysis
  • Lack of parental consent for participation in the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Children aged 1-7 years undergoing orchiopexy who received a transversalis fascia plane block.
Children Aged 1-7 Years Undergoing Orchiopexy Who Received a Posterior Quadratus Lumborum Block

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to First Analgesic Requirement After Surgery
Time Frame: First 24 hours postoperatively
The time elapsed from the end of surgery to the administration of the first rescue analgesic.
First 24 hours postoperatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
FLACC Pain Scores at Specified Time Intervals
Time Frame: First 24 hours postoperatively
Pain assessment using the Face, Legs, Activity, Cry, Consolability (FLACC) scale (score range: 0-10; higher scores indicate worse pain) at 30 minutes, 1 hour, 2 hours, 4 hours, 6 hours, 12 hours, and 24 hours postoperatively.
First 24 hours postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2025

Primary Completion (Actual)

November 1, 2025

Study Completion (Actual)

November 1, 2025

Study Registration Dates

First Submitted

December 3, 2025

First Submitted That Met QC Criteria

December 3, 2025

First Posted (Estimated)

December 16, 2025

Study Record Updates

Last Update Posted (Actual)

December 31, 2025

Last Update Submitted That Met QC Criteria

December 25, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • E-48670771-514.9900

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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