Retrolaminar Plane Block Versus Anterior Quadratus Lumborum Block in Pediatric Urogenital Surgery

NCT07711496 | Not Yet Recruiting

• 1 other identifier: ctf- rlb&antqlb
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

Brief Summary

Effective control of postoperative pain following pediatric lower urogenital surgery is important for enhancing recovery and reducing opioid requirements. Anterior quadratus lumborum block and retrolaminar block are two ultrasound-guided truncal block techniques used for perioperative analgesia in lower abdominal surgery. However, direct comparisons of their analgesic efficacy in pediatric lower urogenital procedures remain limited. This prospective, randomized, controlled trial will enroll 76 pediatric patients aged 6 months to 12 years with American Society of Anesthesiologists physical status I-III who are scheduled for elective lower urogenital surgery. Participants will be randomly assigned in a 1:1 ratio to receive either an anterior quadratus lumborum block or a retrolaminar block. Both techniques will be performed under ultrasound guidance in addition to standardized general anesthesia. The primary outcome will be rescue analgesic requirement during the first 24 postoperative hours. Secondary outcomes will include postoperative pain scores, time to first rescue analgesic administration, intraoperative remifentanil consumption, adverse effects such as nausea and vomiting, and caregiver satisfaction. The study aims to compare the postoperative analgesic efficacy and safety of anterior quadratus lumborum block and retrolaminar block in pediatric patients undergoing lower urogenital surgery.

Conditions

Pediatric Regional Anesthesia; Retrolaminar Block; Pediatric Postoperative Pain

Keywords

pediatric anesthesia; pediatric regional anesthesia; retrolaminar block; pediatric pain management

Outcome Measures

Primary Outcomes (1)

• Total Rescue Analgesic Requirement During the First 24 Postoperative Hours

  Total rescue analgesic consumption during the first 24 postoperative hours will be recorded. Pain assessment will be performed using the Face, Legs, Activity, Cry, and Consolability Scale. The scale ranges from 0 to 10, with higher scores indicating greater pain intensity. Rescue analgesia will be administered when the score is 4 or higher.

  First 24 hours after surgery

Secondary Outcomes (3)

• Postoperative Pain Scores

  Postoperative 1, 2, 4, 8, 16, and 24 hours

• Time to First Rescue Analgesic Administration

  First 24 hours after surgery

• Intraoperative Remifentanil Consumption

  From induction of anesthesia until the end of surgery

Study Arms (2)

Anterior Quadratus Lumborum Block Group

EXPERIMENTAL

Participants assigned to this group will receive an ultrasound-guided anterior quadratus lumborum block following induction of general anesthesia for postoperative analgesia. The block will be performed under sterile conditions using 0.25 percent bupivacaine at a volume of 0.4 milliliters per kilogram. Standardized general anesthesia and postoperative analgesic protocols will be applied to all participants.

Procedure: Anterior Quadratus Lumborum Block

Retrolaminar Block Group

EXPERIMENTAL

Participants assigned to this group will receive an ultrasound-guided retrolaminar block following induction of general anesthesia for postoperative analgesia. The block will be performed under sterile conditions using 0.25 percent bupivacaine at a volume of 0.4 milliliters per kilogram. Standardized general anesthesia and postoperative analgesic protocols will be applied to all participants.

Procedure: Retrolaminar Block

Interventions

Retrolaminar Block PROCEDURE

An ultrasound-guided retrolaminar block will be performed after induction of general anesthesia. After identification of the target vertebral lamina, 0.25 percent bupivacaine will be administered into the retrolaminar plane at a volume of 0.4 milliliters per kilogram.

Retrolaminar Block Group

Anterior Quadratus Lumborum Block PROCEDURE

An ultrasound-guided anterior quadratus lumborum block will be performed after induction of general anesthesia. Following identification of the quadratus lumborum and psoas major muscles, 0.25 percent bupivacaine will be injected into the fascial plane between these muscles at a volume of 0.4 milliliters per kilogram.

Anterior Quadratus Lumborum Block Group

Eligibility Criteria

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

You may qualify if:

• Age between 6 months and 12 years
• Scheduled for lower abdominal urogenital surgery (e.g., inguinal hernia repair or orchiopexy for undescended testis)
• American Society of Anesthesiologists physical status classification I-III
• Written informed consent obtained from a parent or legal guardian

You may not qualify if:

• History of allergy to local anesthetic agents
• Presence of infection at the planned injection site
• Coagulopathy or any other condition contraindicating regional anesthesia
• Planned laparoscopic orchiopexy
• American Society of Anesthesiologists physical status classification IV
• Inability to obtain informed consent from a parent or legal guardian
• Anticipated requirement for postoperative intensive care unit admission

Sponsors & Collaborators

• Istanbul University - Cerrahpasa: lead

Study Sites (1)

Istanbul University-Cerrahpasa, Cerrahpasa Medicine of Faculty

Bakırköy, Istanbul, 34153, Turkey (Türkiye)

Location

Study Officials

• münevver kayhan

  Istanbul University-Cerrahpasa, Cerrahpasa Medicine of Faculty

  PRINCIPAL INVESTIGATOR

• Ayse Cigdem Tutuncu, Professor Doctor

  Istanbul University-Cerrahpasa, Cerrahpasa Medicine of Faculty

  STUDY DIRECTOR

• Pinar Kendigelen, Professor Doctor

  Istanbul University-Cerrahpasa, Cerrahpasa Medicine of Faculty

  STUDY CHAIR

Central Study Contacts

münevver kayhan, Lecturer Doctor

CONTACT

02124143000; munevver.kayhan@iuc.edu.tr

Ayse Cigdem Tutuncu, Professor Doctor

CONTACT

02124143000; actutuncu@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The anesthesiologist responsible for evaluating eligibility criteria, monitoring intraoperative and postoperative pain scores and analgesic consumption, collecting study data, and performing statistical analyses will be blinded to group allocation. Participants and their caregivers will also remain blinded throughout the study. Randomization will be conducted by an independent investigator who will not be involved in patient recruitment, block performance, perioperative management, outcome assessment, or data analysis. Due to the nature of the interventions, the anesthesiologist performing the regional block procedures will be aware of group allocation and cannot be blinded. This anesthesiologist will not participate in postoperative assessments, data collection, or statistical analyses. Postoperative pain assessments on the ward will be performed every 4 hours by blinded nursing staff using the Face, Legs, Activity, Cry, and Consolability Scale. Patients with a score of 4 or greater w
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Model Details: Participants will be randomly assigned in a 1:1 ratio to one of two parallel intervention groups. Patients in the first group will receive an ultrasound-guided anterior quadratus lumborum block, while patients in the second group will receive an ultrasound-guided retrolaminar block following induction of general anesthesia. Both blocks will be performed under standardized conditions using 0.25 percent bupivacaine at a volume of 0.4 milliliters per kilogram. Postoperative analgesic outcomes, rescue analgesic requirements, adverse events, and caregiver satisfaction will be compared between the two groups.

Study Record Dates

• First Submitted: July 14, 2026
• First Posted: July 17, 2026
• Study Start: July 25, 2026
• Primary Completion (Estimated): July 20, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: July 17, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)