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).
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
- Conditions the study is for
- Pediatric Regional Anesthesia, Retrolaminar Block, Pediatric Postoperative Pain
- 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.
Turkey (Türkiye)1 site
Istanbul University-Cerrahpasa, Cerrahpasa Medicine of Faculty
Bakırköy, Istanbul, 34153
münevver kayhan, Lecturer Doctor, 02124143000, munevver.kayhan@iuc.edu.tr
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Retrolaminar Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
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
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
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.
- First posted17 Jul 2026
- Study start25 Jul 2026 (estimated)
- Primary completion20 Jul 2027 (estimated)
- Study completion1 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric Regional AnesthesiaStudies of the same condition, open and under way.
- More trials run by Istanbul University - CerrahpasaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Münevver Kayhan, Istanbul University - Cerrahpasa
- Investigators
- münevver kayhan, Principal investigator, Istanbul University-Cerrahpasa, Cerrahpasa Medicine of FacultyAyse Cigdem Tutuncu, Professor Doctor, Study director, Istanbul University-Cerrahpasa, Cerrahpasa Medicine of FacultyPinar Kendigelen, Professor Doctor, Study chair, Istanbul University-Cerrahpasa, Cerrahpasa Medicine of Faculty
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
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07711496
- Acronym / sponsor ID
- ctf- rlb&antqlb
- Keywords
- pediatric anesthesia, pediatric regional anesthesia, retrolaminar block, pediatric pain management
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 76 participants (estimated)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 25 Jul 2026 (estimated)
- Primary completion
- 20 Jul 2027 (estimated)
- Study completion
- 1 Sep 2027 (estimated)
- First posted
- 17 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Anterior Quadratus Lumborum Block Group | Experimental | Procedure: Anterior Quadratus Lumborum BlockParticipants 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. |
| Retrolaminar Block Group | Experimental | Procedure: Retrolaminar BlockParticipants 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. |
Who may qualify
- Ages
- 6 months to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anterior Quadratus Lumborum BlockAn 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. | Procedure or surgery | Anterior Quadratus Lumborum Block Group |
| Retrolaminar BlockAn 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. | Procedure or surgery | Retrolaminar Block Group |
Primary outcome
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.
3 secondary outcomes
Postoperative Pain Scores
Time frame: Postoperative 1, 2, 4, 8, 16, and 24 hours
Time to First Rescue Analgesic Administration
Time frame: First 24 hours after surgery
Intraoperative Remifentanil Consumption
Time frame: From induction of anesthesia until the end of surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
münevver kayhan principal investigator
Istanbul University-Cerrahpasa, Cerrahpasa Medicine of Faculty
Ayse Cigdem Tutuncu, Professor Doctor study director
Istanbul University-Cerrahpasa, Cerrahpasa Medicine of Faculty
Pinar Kendigelen, Professor Doctor study chair
Istanbul University-Cerrahpasa, Cerrahpasa Medicine of Faculty
1 site in 1 country: see every site and its status.
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.