Cryptorchidism, Postoperative Pain
Conditions
Brief summary
This randomized, double-blind study compares the postoperative analgesic efficacy of ultrasound-guided Posterior Quadratus Lumborum Block (QLB) versus Quadroiliac Plane Block (QIPB) in pediatric patients aged 1-7 years undergoing unilateral undescended testis surgery.
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.
Interventions
PROCEDUREUltrasound-guided Posterior Quadratus Lumborum Block.
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 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
Sponsors
Medipol University
Biruni University
Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
1 Years to 7 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative Pain Score (FLACC) at 12 Hours | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to First Rescue Analgesic Request. | Up to 24 hours. | Time in minutes from surgery completion to the first dose of rescue analgesia. |
| Total Postoperative Analgesic Consumption | 24 hours post-surgery. | Cumulative amount of rescue analgesics consumed (mg). |
| Incidence of Postoperative Complications. | Up to 24 hours. | Assessment of complications such as urinary retention, motor block, hematoma, or ecchymosis at the injection site. |
| Postoperative Pain Scores (FLACC) at Other Time Points. | 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. |
Countries
Turkey (Türkiye)
Contacts
STUDY_CHAIRSelçuk Alver
Biruni University
STUDY_CHAIRVolkan Özen
Prof. Dr. Cemil Tascioglu City Hospital, Istanbul.
Outcome results
None listed