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Caudal vs Dorsal Penile Nerve Block for Postoperative Analgesia in Children Undergoing Hypospadias Repair (CaD-DPNB)

NCT07306806 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-02-03

No results posted yet for this study

Summary

This prospective, randomized clinical trial conducted at Ain Shams University Hospitals evaluated the analgesic efficacy of dorsal penile nerve block versus caudal epidural block in 30 male children undergoing primary hypospadias repair. Patients were randomly assigned to the penile block group (n=15) or the caudal block group (n=15). Both groups received standardized general anesthesia. The dorsal penile nerve block was performed with 0.25% bupivacaine (1 mL/kg) via a subpubic approach, while the caudal block used 0.25% bupivacaine (0.5 mL/kg) through the sacral hiatus. Block failure was managed with intravenous fentanyl. Baseline demographics and operative duration were comparable between groups. Postoperative pain assessed using the FLACC scale showed superior early analgesia in the caudal group at 0 and 3 hours, with comparable scores at 6-12 hours. The caudal block group required rescue analgesia later and consumed lower total doses of paracetamol and pethidine within 24 hours. However, caudal block delayed ambulation compared to the penile block group. No major complications were reported. The study concludes that both blocks are safe and effective; caudal epidural provides superior early postoperative analgesia, while dorsal penile block may be preferred when early ambulation is desired.

Conditions

  • Hypospadias Repair
  • Pediatric Anesthesia
  • Postoperative Analgesia

Interventions

PROCEDURE

Caudal epidural block

A caudal epidural block was performed after induction of general anesthesia with the patient in the lateral decubitus position. A 22-G needle was inserted through the sacral hiatus into the caudal epidural space after loss of resistance of the sacrococcygeal membrane. Bupivacaine 0.25% at a dose of 0.5 mL/kg was injected following negative aspiration.

PROCEDURE

Dorsal Penile nerve Block

A dorsal penile nerve block was performed after induction of general anesthesia using the subpubic approach with the patient in the supine position. A 22-G needle was inserted bilaterally at the 10 and 2 o'clock positions near the base of the penis after gentle caudal traction. After negative aspiration, bupivacaine 0.25% at a dose of 1 mL/kg, divided equally on both sides, was injected to block the dorsal penile nerves.

Sponsors & Collaborators

  • Ain Shams University

    lead OTHER

Principal Investigators

  • Mariam K Habib, MD · Ain Shams University

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
1 Year
Max Age
8 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-28
Primary Completion
2022-03-01
Completion
2022-04-01

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07306806 on ClinicalTrials.gov