Comparison of Transversus Fascial Plane Block and Anterior Quadratus Lumborum Block for Lower Urogenital Surgery in Pediatric Patients.
Phase: NA
Conditions: Regional Anesthesia Block, Anesthesia and Analgesia, Pediatric Anesthesia, Pediatric Regional Anesthesia
Sponsor: Istanbul University - Cerrahpasa

Cover Page for ClinicalTrials.gov Posting 
Official Title: 
Comparison of the Transversus Fascial Plane Block and the Anterior Quadratus Lumborum 
Block for Lower Urogenital Surgery in Pediatric Patients 
NCT Number: 
NCT07256899 
Document Type: 
Protocol (including Ethics Committee Approval & Statistical Analysis Plan) 
Document Date: 
27 October 2025 
 
 

ENGLISH VERSION 
 
STUDY PROTOCOL AND ETHICS 
 
This randomized controlled study was conducted in pediatric patients aged 6 months to 12 
years undergoing lower abdominal urogenital surgery at Istanbul University-Cerrahpaşa. 
Ethical approval was obtained from the Institutional Ethics Committee (Approval No: 
1452066; Date: 27 October 2025), and the study was registered at ClinicalTrials.gov 
(NCT07256899). Written informed consent was obtained from all legal guardians. 
 
Patients were randomized into two groups: anterior quadratus lumborum block (QLB) and 
transversalis fascia plane block (TFPB). Blocks were performed under ultrasound guidance 
using 0.25% bupivacaine at a dose of 0.4 mL/kg. 
 
Primary outcomes included perioperative pain scores and analgesic consumption. 
Secondary outcomes included time to first analgesic requirement and patient/parent 
satisfaction. 
 
STATISTICAL ANALYSIS 
 
Statistical analyses and visualizations were performed using R software (version 4.4.2). 
Normality of continuous variables was assessed using histograms and the Shapiro–Wilk 
test. As normal distribution assumptions were not met, continuous variables were 
presented as median and interquartile range (IQR), while categorical variables were 
expressed as frequencies and percentages. 
 
Comparisons between two independent groups (Ant-QLB and TFPB) were performed using 
the Mann–Whitney U test for continuous variables and Fisher’s Exact test for categorical 
variables. Repeated measurements of intraoperative hemodynamic parameters (heart rate 
and mean arterial pressure) and postoperative pain scores were analyzed using linear 
mixed-effects models, including group, time, and group × time interaction as fixed effects. 
 
Time to first postoperative analgesic requirement (0–8 hours and 0–24 hours) was 
analyzed using Kaplan–Meier survival analysis and compared using the log-rank test. 
 
The lme4 and lmerTest packages were used for mixed-effects modeling; the survival 
package was used for survival analysis; and ggplot2 and survminer packages were used for 
visualization. All tests were two-sided, and p < 0.05 was considered statistically significant. 
 
 
 

TÜRKÇE ORİJİNAL 
İSTATİSTİKSEL ANALİZ 
 
İstatistiksel analizler ve görselleştirmeler R yazılımı (ver. 4.4.2) kullanılarak gerçekleştirildi. 
Sürekli değişkenlerin normal dağılıma uygunluğu histogramlar ve Shapiro–Wilk testi ile 
değerlendirildi. Normal dağılım varsayımı sağlanmadığından sürekli değişkenler medyan ve 
çeyrekler arası aralık (IQR) olarak sunuldu. 
 
İki bağımsız grup arasında karşılaştırmalarda Mann–Whitney U testi ve Fisher’s Exact test 
kullanıldı. Tekrarlı ölçümler Linear Mixed-Effects Models ile analiz edildi. Sağkalım 
analizleri Kaplan–Meier ve log-rank test ile gerçekleştirildi. Tüm testler çift yönlü olup p < 
0.05 anlamlı kabul edildi.