NCT07286799

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
54

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2025

Shorter than P25 for all trials

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2025

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 3, 2025

Completed
13 days until next milestone

First Posted

Study publicly available on registry

December 16, 2025

Completed
Last Updated

December 31, 2025

Status Verified

December 1, 2025

Enrollment Period

6 months

First QC Date

December 3, 2025

Last Update Submit

December 25, 2025

Conditions

Keywords

Transversalis fascia plane blockQuadratus lumborum blockOrchiopexyPain management

Outcome Measures

Primary Outcomes (1)

  • Time to First Analgesic Requirement After Surgery

    The time elapsed from the end of surgery to the administration of the first rescue analgesic.

    First 24 hours postoperatively

Secondary Outcomes (1)

  • FLACC Pain Scores at Specified Time Intervals

    First 24 hours postoperatively

Study Arms (2)

Children aged 1-7 years undergoing orchiopexy who received a transversalis fascia plane block.

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

Children Aged 1-7 Years Undergoing Orchiopexy Who Received a Posterior Quadratus Lumborum Block

Eligibility Criteria

Age1 Year - 7 Years
Sexmale
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • 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
  • Lack of parental consent for participation in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Prof. Dr. Cemil Taşcıoğlu Şehir Hastanesi

Istanbul, Şişli, 34384, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident Doctor

Study Record Dates

First Submitted

December 3, 2025

First Posted

December 16, 2025

Study Start

May 1, 2025

Primary Completion

November 1, 2025

Study Completion

November 1, 2025

Last Updated

December 31, 2025

Record last verified: 2025-12

Locations