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Analgesia in Pediatric Hypospadias Surgeries

NCT06410482 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2024-05-13

No results posted yet for this study

Summary

The primary aim of the current study will be to use the duration until the first postoperative analgesic requirement after two different block techniques to compare the analgesic effect.

The secondary aims will be to compare the two methods for postoperative Children's Hospital Eastern Ontario Pain Scale (CHEOPS) scores, complications and parental satisfaction scores.

Conditions

  • Hypospadias

Interventions

PROCEDURE

US guided caudal block

After placing the patient in the left lateral position (hips and knees flexed) following monitoring and induction of anaesthesia, the field will be sterilized with 70% alcohol in 2% chlorhexidine. Initial scanning in the transverse plane allows for visualization of the midline and identification of the sacrococcygeal ligament between the 2 sacral cornua. The 2 cornua resemble the 2 eyes of a frog and thus are collectively called the frog-eye sign. The US probe is then rotated 90 degrees to acquire a longitudinal view. The needle is then advanced at a 20-degree angle with needle tip and length visualization Once the needle is confirmed to be in the caudal space on the screen, carefully aspirate to confirm absence of CSF or blood. A slow injection of the local anaesthetic can then be performed, dose of (0.2 mL/kg 0.25% bupivacaine and 1 μg/kg of dexmedetomidine

PROCEDURE

Dorsal penile nerve block

after general anesthesia induction. With the patient in the supine position. After skin sterilization the US linear probe will be transversely placed on the root of the penis. After placing the penis in gentle traction, a50 mm block needle will be inserted from the lateral part of the penis root towards the dorsal section of the penis with the in-plane technique, It will be advanced through Dartos fascia until resistance to the needle disappeared. Once the superficial sheath will be passed, the tip of the needle will be advanced into Buck's fascia and then positioned between Buck's fascia and tunica albuginea, lateral to the dorsal artery. After making sure there will be no blood with negative aspiration, half of the total 0.2 mL/kg dose of 0.25% bupivacaine will be administered while observing its distribution with US. The same procedure will be then repeated on the other side of the penis.

Sponsors & Collaborators

  • Assiut University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
1 Year
Max Age
7 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-05-31
Primary Completion
2025-05-31
Completion
2025-06-30

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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 NCT06410482 on ClinicalTrials.gov