Analgesic Comparison of Transversus Fascial Plane and Quadratus Lumborum Blocks in Pediatric Urogenital Procedures

NCT07256899 | Completed

• 1 other identifier: ctf-qlb/tfpb-02
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to compare the analgesic effectiveness of the preoperatively administered Anterior Quadratus Lumborum Block (Anterior QLB) and the Transversalis Fascia Plane Block (TFP block) in children undergoing lower abdominal urogenital surgery. The study will include children aged 6 months to 12 years, with randomization performed using the sealed opaque envelope method, and outcome assessment conducted in a double-blinded manner. All patients will receive a standardized anesthesia protocol, and the regional blocks will be performed under ultrasound (US)-guided techniques. Perioperative evaluations will include pain levels, hemodynamic responses, additional analgesic requirements, block performance time, technical success rate, and family satisfaction. Postoperative pain will be monitored using the Face, Legs, Activity, Cry, Consolability (FLACC) scale, and analgesics will be administered when necessary. By comparing these two commonly used regional anesthesia techniques, this study aims to contribute to improved perioperative pain management strategies in the pediatric population.

Conditions

Regional Anesthesia Block; Anesthesia and Analgesia; Pediatric Anesthesia; Pediatric Regional Anesthesia

Keywords

anterior QLB; Transversalis Fasia Plane block; Pediatric Regional Analgesia

Outcome Measures

Primary Outcomes (1)

• Total Analgesic Consumption

  Total amount of analgesics (including remifentanil, tramadol, and paracetamol) administered within 24 hours will be recorded and compared between groups.

  intraoperatif periods and First 24 hours postoperatively

Secondary Outcomes (3)

• Postoperative Pain Score

  0, 5, 10, 20, 30, 45, 60 minutes intraoperatively; 2, 4, 8, 12, 24 hours postoperatively

• Time to First Rescue Analgesia

  0-24 hours postoperatively

• Parent/Patient Satisfaction

  16th and 24th postoperative hours

Study Arms (2)

Anterior QLB - Preoperative ultrasound-guided anterior quadratus lumborum block

EXPERIMENTAL

Preoperative ultrasound-guided anterior quadratus lumborum block administered according to standardized anesthesia protocol.

Procedure: Anterior Quadratus Lumborum Block (QLB)

TFP Block - Preoperative ultrasound-guided transversalis fascia plane block

EXPERIMENTAL

Preoperative ultrasound-guided transversalis fascia plane block administered according to standardized anesthesia protocol.

Procedure: Transversalis Fascia Plane (TFP / TAP) Block

Interventions

Transversalis Fascia Plane (TFP / TAP) Block PROCEDURE

Participants in this group will receive a preoperative ultrasound-guided transversalis fascia plane block. The block will be performed supine under sterile conditions using an in-plane technique with a linear ultrasound probe. The dose of 0.4 ml/kg of 0.25% bupivacaine will be administered according to age and weight. Standardized anesthesia protocols will be applied for all patients. Postoperative pain will be assessed using FLACC scores, and additional analgesics will be administered if required.

TFP Block - Preoperative ultrasound-guided transversalis fascia plane block

Anterior Quadratus Lumborum Block (QLB) PROCEDURE

Participants in this group will receive a preoperative ultrasound-guided anterior quadratus lumborum block. The block will be performed under sterile conditions using an in-plane technique with a linear ultrasound probe. The dose of 0.4 ml/kg of 0.25% bupivacaine will be administered according to age and weight. Standardized anesthesia protocols will be applied for all patients. Postoperative pain will be assessed using FLACC scores, and additional analgesics will be administered if required.

Anterior QLB - Preoperative ultrasound-guided anterior quadratus lumborum block

Eligibility Criteria

• Age: 6 Months - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Age 6 months to 12 years
• Scheduled for lower abdominal urogenital surgery (e.g., inguinal hernia repair, undescended testis surgery)
• ASA physical status I-III
• Parental/guardian informed consent obtained

You may not qualify if:

• Allergy to local anesthetics
• Infection at the injection site
• Coagulopathy or other contraindications to regional anesthesia
• Laparoscopic orchiopexy scheduled
• ASA physical status IV
• Inability to obtain consent from parent/guardian
• Expected need for postoperative intensive care

Sponsors & Collaborators

• Istanbul University - Cerrahpasa: lead

Study Sites (1)

Istanbul University-Cerrahpasa, Cerrahpasa Medicine of Faculty

Bakırköy, Istanbul, 34153, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Agnosia

Interventions

Dental Occlusion

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dentistry; Dental Physiological Phenomena; Digestive System and Oral Physiological Phenomena

Study Officials

• Pinar Kendigelen

  Istanbul University-Cerrahpasa, Cerrahpasa Medicine of Faculty

  PRINCIPAL INVESTIGATOR

• Munevver Kayhan

  Istanbul University-Cerrahpasa, Cerrahpasa Medicine of Faculty

  STUDY CHAIR

• Ayse Cigdem Tutuncu, Professor Doctor

  Istanbul University-Cerrahpasa, Cerrahpasa Medicine of Faculty

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The anesthesiologist who evaluated the inclusion and exclusion criteria, monitored clinical pain scores and analgesic consumption during the intraoperative and postoperative periods, and performed data analysis, as well as the patients included in the study, were blinded. The anesthesiologist who knew the groups and performed the block application could not be blinded due to the study design. Postoperative ward monitoring was recorded in the late period, and pain levels were assessed every 4 hours by blinded ward nurses. During this period, patients with a FLACC score ≥4 were given 10 mg/kg paracetamol as a rescue analgesic. Patients were evaluated at 16 and 24 hours by the blinded investigator who performed clinical monitoring; pain scores and analgesic consumption data were obtained from nurse observation forms.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Model Details: This study uses a parallel assignment design in which participants are randomly allocated to one of two intervention groups: the Anterior Quadratus Lumborum Block (QLB) group or the Transversalis Fascia Plane (TFP) block group. Each participant receives only one type of block, and there is no crossover between groups.Patients were assigned to two groups on the morning of surgery, prior to intubation: the Anterior Quadratus Lumborum Block (QLB) group or the Transversalis Fascia Plane (TFP) block group, and randomized 1:1. Randomization was achieved using a computer-generated random number sequence; assignment confidentiality was maintained using sequentially numbered, opaque, and sealed envelopes. The randomization process was conducted by an independent investigator who was not involved in patient inclusion, block application, or clinical evaluations. The anesthesiologist who assessed the inclusion and exclusion criteria, monitored intraoperative and postoperative clinical pain scores

Study Record Dates

• First Submitted: November 20, 2025
• First Posted: December 1, 2025
• Study Start: December 1, 2025
• Primary Completion: March 5, 2026
• Study Completion: March 5, 2026
• Last Updated: March 19, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)