Hypospadias, Postoperative Pain
Conditions
Brief summary
This randomized controlled trial aims to compare the postoperative analgesic efficacy of ultrasound-guided Sacral Erector Spinae Plane (ESP) block versus Dorsal Penile Nerve Block (DPNB) in pediatric patients aged 1-7 years undergoing hypospadias surgery. The primary outcome is the pain score assessed by the FLACC scale at the 12th postoperative hour
Detailed description
Hypospadias surgery in pediatric patients can cause significant postoperative pain. While Dorsal Penile Nerve Block (DPNB) is a standard regional technique, the Sacral Erector Spinae Plane (ESP) block has emerged as a potential alternative for trunk and pelvic analgesia. In this prospective, randomized, double-blind study, 70 pediatric patients (ASA I-II, aged 1-7 years) will be randomly assigned to receive either a Sacral ESP block or a DPNB under general anesthesia. Both blocks will be performed under ultrasound guidance using 0.25% bupivacaine, administered at a volume of 0.4 mL/kg for the Sacral ESP block and 0.4 mL/kg for the DPNB. Postoperative pain will be assessed using the FLACC (Face, Legs, Activity, Cry, Consolability) scale at 30 minutes, 1, 2, 6, 12, and 24 hours. The study aims to determine if Sacral ESP provides superior or non-inferior analgesia compared to DPNB, specifically focusing on the 12th-hour pain scores, total analgesic consumption, and time to first rescue analgesic
Interventions
PROCEDURESacral ESP Block Group
Patients will be placed in the lateral decubitus position. Under ultrasound guidance, the plane between the multifidus muscle and the sacral lamina (erector spinae plane) will be identified at the sacral level. A total of 0.4 mL/kg of 0.25% Bupivacaine will be injected bilaterally
PROCEDUREDorsal Penile Nerve Block Group
Patients will be in the supine position. Under ultrasound guidance, the needle will be advanced under Buck's fascia at the penile base (pubic symphysis level). A total of 0.4 mL/kg of 0.25% Bupivacaine will be injected bilaterally
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
* Pediatric male patients aged 1-7 years. * ASA (American Society of Anesthesiologists) physical status I or II. * Scheduled for elective hypospadias surgery. * Written informed consent obtained from parents/guardians
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 history of psychiatric disease. * Liver or kidney dysfunction
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative Pain Score (FLACC) at 12 Hours | 30 minutes, 1, 2, 4, 6, 12 and 24 hours post-surgery | Pain severity assessed using the Face, Legs, Activity, Cry, Consolability (FLACC) scale at 30 minutes, 1, 2, 4, 6, 12 and 24 hours. The total score ranges from 0 to 10, where higher scores indicate worse pain. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total Postoperative Analgesic Consumption | 24 hours post-surgery | The cumulative amount of rescue analgesics (mg) consumed. |
| Incidence of Postoperative Complications. | Up to 24 hours | Presence of motor block, urinary retention, hematoma/ecchymosis at injection site, vomiting, or pruritus. |
| Postoperative Pain Scores (FLACC) at Other Time Points | 30 minutes, 1, 2, 4, 6, 12 and 24 hours post-surgery | Pain severity assessed using the Face, Legs, Activity, Cry, Consolability (FLACC) scale at 30 minutes, 1, 2, 4, 6, 12 and 24 hours. The total score ranges from 0 to 10, where higher scores indicate worse pain. |
Countries
Turkey (Türkiye)
Contacts
STUDY_CHAIRSelçuk Alver
Istanbul Biruni University Hospital, Istanbul, Turkey.
STUDY_CHAIRVolkan Özen
Prof. Dr. Cemil Tascioglu City Hospital, Istanbul, Turkey
Outcome results
None listed