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Pediatric Regional AnesthesiaNCT07711496

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

A study testing Anterior Quadratus Lumborum Block and Retrolaminar Block in people with Pediatric Regional Anesthesia and Retrolaminar Block, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 6 months to 12 years
What is being tested?
Anterior Quadratus Lumborum Block and Retrolaminar Block
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
76 participants
Where
1 siteTurkey (Türkiye)
Study dates
25 Jul 2026to 1 Sep 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 6 months to 12 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

münevver kayhan, Lecturer Doctor contact

02124143000

munevver.kayhan@iuc.edu.tr

Ayse Cigdem Tutuncu, Professor Doctor contact

02124143000

actutuncu@gmail.com

Turkey (Türkiye)1 site
  • Istanbul University-Cerrahpasa, Cerrahpasa Medicine of Faculty

    Bakırköy, Istanbul, 34153

    münevver kayhan, Lecturer Doctor, 02124143000, munevver.kayhan@iuc.edu.tr

Other trials in Turkey (Türkiye)

About this study

Official 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

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.

Read the detailed description

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.

Being tested
Anterior Quadratus Lumborum Block, Retrolaminar Block
Keywords
pediatric anesthesia, pediatric regional anesthesia, retrolaminar block, pediatric pain management

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Anterior Quadratus Lumborum BlockProcedure or surgery

    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 BlockProcedure or surgery

    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.

Study groups in NCT07711496
Study groupRoleWhat they receive
Anterior Quadratus Lumborum Block GroupExperimentalParticipants 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.
Receives: Procedure: Anterior Quadratus Lumborum Block
Retrolaminar Block GroupExperimentalParticipants 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.
Receives: Procedure: Retrolaminar Block

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: First 24 hours after surgery

Secondary outcomes (3)
  1. Postoperative Pain Scores

    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.

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

  2. Time to First Rescue Analgesic Administration

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

    Measured: First 24 hours after surgery

  3. Intraoperative Remifentanil Consumption

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

    Measured: From induction of anesthesia until the end of surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Jul 2026
  2. Study start25 Jul 2026 (estimated)
  3. Primary completion20 Jul 2027 (estimated)
  4. Study completion1 Sep 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
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.
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
76 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07711496
Sponsor's protocol ID
ctf- rlb&antqlb
Status last verified
Jul 2026
First submitted
14 Jul 2026
Last updated
17 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Anterior Quadratus Lumborum Block and Retrolaminar Block in people with Pediatric Regional Anesthesia and Retrolaminar Block, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 17 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact münevver kayhan, Lecturer Doctor (02124143000, munevver.kayhan@iuc.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Total Rescue Analgesic Requirement During the First 24 Postoperative Hours (time frame: First 24 hours after surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2026.

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