Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07711496

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

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Age range

6 month–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Istanbul University-Cerrahpasa, Cerrahpasa Medicine of Faculty

Bakırköy, Istanbul, 34153, Turkey (Türkiye)

Location contact

münevver kayhan, Lecturer Doctor

CONTACT

[email protected]

02124143000

About this study

Effective postoperative pain control following pediatric lower urogenital surgery is essential for improving recovery, reducing distress, facilitating oral intake, and decreasing opioid consumption. Ultrasound-guided regional anesthesia techniques have become an important component of multimodal analgesia strategies in pediatric anesthesia. Anterior quadratus lumborum block and retrolaminar block are two truncal block techniques used to provide analgesia for lower abdominal surgical procedures. However, direct comparisons of the postoperative analgesic efficacy of these techniques in pediatric lower urogenital surgery remain limited.

The aim of this study is to compare the postoperative analgesic efficacy of anterior quadratus lumborum block and retrolaminar block in pediatric patients undergoing lower urogenital surgery. Secondary objectives include evaluation of rescue analgesic requirements, postoperative pain scores, time to first rescue analgesic administration, intraoperative opioid consumption, adverse effects, and caregiver satisfaction.

This study is designed as a prospective, randomized, controlled, assessor-blinded clinical trial involving pediatric patients aged 6 months to 12 years with American Society of Anesthesiologists physical status I to III who are scheduled for elective lower urogenital surgery. Eligible participants will be randomly assigned in a 1:1 ratio to either the anterior quadratus lumborum block group or the retrolaminar block group using a computer-generated randomization sequence. Allocation concealment will be maintained using sequentially numbered opaque sealed envelopes.

All patients will receive standardized general anesthesia. Following induction of anesthesia, regional blocks will be performed under sterile conditions with ultrasound guidance. In both groups, 0.25 percent bupivacaine will be administered at a volume of 0.4 milliliters per kilogram.

Intraoperative monitoring will include heart rate and arterial blood pressure measurements recorded at baseline and predefined time points during surgery. If either parameter increases by 20 percent or more compared with baseline values, remifentanil infusion will be initiated and total remifentanil consumption will be recorded.

Postoperative pain assessment will be performed using the Face, Legs, Activity, Cry, and Consolability Scale. This scale ranges from 0 to 10 points, with higher scores indicating greater pain intensity. Rescue analgesia will be administered when the score is 4 or higher.

Patients will be evaluated in the post-anesthesia care unit and during ward follow-up at predefined time points. Pain scores, total rescue analgesic consumption, time to first rescue analgesic administration, adverse events including postoperative nausea and vomiting, and caregiver satisfaction will be recorded.

The primary outcome measure is total rescue analgesic requirement during the first 24 postoperative hours. Secondary outcome measures include postoperative pain scores, time to first rescue analgesic administration, intraoperative remifentanil consumption, incidence of postoperative nausea and vomiting, block success, and caregiver satisfaction.

Based on the sample size calculation, a total of 76 patients will be enrolled. Statistical analyses will be performed using appropriate parametric or nonparametric methods, and a p value less than 0.05 will be considered statistically significant.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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.

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.

Primary outcomes

  1. Total Rescue Analgesic Requirement During the First 24 Postoperative Hours

    Time frame: First 24 hours after surgery

    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.

Secondary outcomes

  1. Postoperative Pain Scores

    Time frame: Postoperative 1, 2, 4, 8, 16, and 24 hours

    Pain intensity will be assessed using the Face, Legs, Activity, Cry, and Consolability Scale. Scores range from 0 to 10, with higher scores indicating greater pain intensity.

  2. Time to First Rescue Analgesic Administration

    Time frame: First 24 hours after surgery

    The time from completion of surgery to the administration of the first rescue analgesic will be recorded in minutes.

  3. Intraoperative Remifentanil Consumption

    Time frame: From induction of anesthesia until the end of surgery

    Total remifentanil consumption during surgery will be recorded in micrograms per kilogram.

Study contacts

Contact information is provided by the study sponsor or research team.

Ayse Cigdem Tutuncu, Professor Doctor

CONTACT

[email protected]

02124143000

münevver kayhan, Lecturer Doctor

CONTACT

[email protected]

02124143000

Sponsors and collaborators

Lead sponsor

Istanbul University - Cerrahpasa

Other

Registry information

Official study title

Comparison of the Postoperative Analgesic Efficacy of Retrolaminar Plane Block and Anterior Quadratus Lumborum Block in Pediatric Lower Urogenital Surgery: A Randomized Controlled Trial

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jul 17, 2026
Registry last updated
Jul 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.