- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07426796
Comparison of Posterior QLB and QIPB in Pediatric Undescended Testis Surgery.
Comparison of the Effects of Posterior Quadratus Lumborum Block and Quadroiliac Plane Block on Analgesic Consumption in Postoperative Pain Management in Pediatric Patients Undergoing Undescended Testis Surgery
Study Overview
Status
Conditions
Detailed Description
Lower abdominal surgeries, such as undescended testis repair (orchiopexy), are common in pediatric patients and can cause significant postoperative pain. While Posterior Quadratus Lumborum Block (QLB) is a known technique for somatic and visceral analgesia, the Quadroiliac Plane Block (QIPB) is a newer approach targeting the fascial plane posterior to the iliac bone.
In this prospective, randomized, controlled trial, 70 pediatric patients (ASA I-II, aged 1-7 years) will be randomly assigned to receive either a Posterior QLB or a QIPB under general anesthesia. Both blocks will be performed using ultrasound guidance with 0.5 mL/kg of 0.25% bupivacaine.
The study aims to evaluate and compare the analgesic efficacy of these two techniques. Postoperative pain will be assessed using the FLACC scale. Secondary objectives include comparing the time to first rescue analgesic, total analgesic consumption, and incidence of complications.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Burak Ömür
- Phone Number: +905056215056
- Email: bomur@medipol.edu.tr
Study Locations
-
-
-
Istanbul, Turkey (Türkiye)
- Recruiting
- İstanbul Medipol University
-
Contact:
- Burak Ömür
- Phone Number: +905056215056
- Email: bomur@medipol.edu.tr
-
Contact:
- Phone Number: +90 4448544
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Male pediatric patients aged 1-7 years.
- ASA physical status I or II.
- Scheduled for unilateral undescended testis surgery.
- Written informed consent obtained.
Exclusion Criteria:
- History of neurological deficit or developmental delay.
- Bleeding diathesis or known coagulopathy.
- History of allergy to local anesthetics.
- Infection or skin lesion at the block injection site.
- Congenital spinal anomaly.
- Mental retardation or psychiatric history.
- Liver or kidney dysfunction.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Posterior QLB Group
Patients will be placed in the lateral decubitus position.
Under ultrasound guidance, the probe will be placed at the posterior axillary line.
The needle will be advanced to the posterior fascial plane of the quadratus lumborum muscle.
A total of 0.5 mL/kg of 0.25% Bupivacaine will be injected
|
Patients will be placed in the lateral decubitus position.
Under ultrasound guidance, the probe will be placed at the posterior axillary line.
The needle will be advanced to the posterior fascial plane of the quadratus lumborum muscle.
A total of 0.5 mL/kg of 0.25% Bupivacaine will be injected.
|
|
Experimental: QIPB Group
Patients will be placed in the lateral decubitus position.
Under ultrasound guidance, the probe will be placed at the level of the iliac crest.
The needle will be targeted to the plane where the quadratus lumborum muscle attaches to the iliac bone.
A total of 0.5 mL/kg of 0.25% Bupivacaine will be injected.
|
Patients will be placed in the lateral decubitus position.
Under ultrasound guidance, the probe will be placed at the level of the iliac crest.
The needle will be targeted to the plane where the quadratus lumborum muscle attaches to the iliac bone.
A total of 0.5 mL/kg of 0.25% Bupivacaine will be injected
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Postoperative Pain Score (FLACC) at 12 Hours
Time Frame: 12 hours post-surgery.
|
Pain severity assessed using the Face, Legs, Activity, Cry, Consolability (FLACC) scale.
The total score ranges from 0 to 10, where higher scores indicate worse pain.
|
12 hours post-surgery.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Time to First Rescue Analgesic Request.
Time Frame: Up to 24 hours.
|
Time in minutes from surgery completion to the first dose of rescue analgesia.
|
Up to 24 hours.
|
|
Total Postoperative Analgesic Consumption
Time Frame: 24 hours post-surgery.
|
Cumulative amount of rescue analgesics consumed (mg).
|
24 hours post-surgery.
|
|
Incidence of Postoperative Complications.
Time Frame: Up to 24 hours.
|
Assessment of complications such as urinary retention, motor block, hematoma, or ecchymosis at the injection site.
|
Up to 24 hours.
|
|
Postoperative Pain Scores (FLACC) at Other Time Points.
Time Frame: 30 minutes, 1, 2, 4, 6, and 24 hours post-surgery.
|
Pain severity assessed using the Face, Legs, Activity, Cry, Consolability (FLACC) scale at 30 minutes, 1, 2, 4, 6, and 24 hours.
The total score ranges from 0 to 10, where higher scores indicate worse pain.
|
30 minutes, 1, 2, 4, 6, and 24 hours post-surgery.
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Chair: Selçuk Alver, Biruni University
- Study Chair: Volkan Özen, Prof. Dr. Cemil Tascioglu City Hospital, Istanbul.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Urogenital Diseases
- Genital Diseases
- Pain
- Neurologic Manifestations
- Endocrine System Diseases
- Postoperative Complications
- Pathologic Processes
- Genital Diseases, Male
- Male Urogenital Diseases
- Gonadal Disorders
- Congenital Abnormalities
- Urogenital Abnormalities
- Testicular Diseases
- Congenital, Hereditary, and Neonatal Diseases and Abnormalities
- Pathological Conditions, Signs and Symptoms
- Signs and Symptoms
- Pain, Postoperative
- Cryptorchidism
Other Study ID Numbers
- 150, 22.01.2026
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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