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NCT Number: NCT06500286

Dorsal Nerve Block and Caudal Block in Hypospedius Repair in Children

Comparison between Dorsal nerve block and caudal block effect in post operative pain in hypospedius repair in children Randomoized clinical trial

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Key information

Age range

2 year–12 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

About this study

  • Group A receive caudal block placing the patient into the left lateral decubitus position. Povidone iodine was used to sterilize the skin. The sacral hiatus was found by palpating the sacral cornu and a 22-G needle was placed through it. After passing through the sacrococcygeal membrane by using the loss of resistance method, the caudal epidural space was entered. Negative aspiration was used to make sure there was no blood or cerebrospinal fluid present and 0.25% bupivacaine was administered at a dose of 0.2 ml/kg. Once the procedure was completed, the patient was placed into the supine Position.

Group B US guided Dorsal penil block. General anesthesia induction was followed by skin sterilization using 70% alcohol in 2% chlorhexidine. The 5-10 MHz linear probe was placed at the penis root, making it possible to observe the corpus cavernosum, corpus spongiosum, dorsal artery and vein, and the deep penile fascia (Buck's fascia) on the transverse plane with gentle penile traction. The in-plane technique was then used to insert a 50-mm block needle toward the dorsal penile section from the lateral part of the penis root. The needle was then advanced from the hyperechoic superficial penis fascia (Dartos fascia) and the superficial sheath was passed. After advancing the needle into Buck's fascia, the needle was placed lateral to the dorsal artery, at a position between Buck's fascia and tunica albuginea. Negative aspiration was performed. US was then used to observe the distribution of the anesthetic while half of the total 0.25% bupivacaine dose (0.2 mL/kg) was administered (Fig. 1). Afterward, the same procedure was also performed on the other side of the penis.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • aged 2-12 years
  • ASA physical status I or II

Exclusion criteria

  • asthmatic patients
  • emergency surgery
  • intellectual disability
  • neurological diseases with agitation-like symptoms
  • renal or hepatic disease,
  • cardiac or respiratory disease
  • allergy to the study drugs
  • parent refusal
  • psychiatric diseases

Treatment and study plan

Marciane

Drug

Group A caudal block 0.25% bupivacaine was administered at a dose of 0.2 ml/k

Other names: bupivacaine

marcaine

Drug

Dorsal penil block 0.25% bupivacaine was administered at a dose of 0.2 ml/k

Other names: bupivacaine

Primary outcomes

  1. Efficacy of dorsal penile block

    Time frame: 1year

    Score of pain visual Analougue Score

Secondary outcomes

  1. Comparison between post operative analegesia effect and side effect of dorsal penileblock and caudal block

    Time frame: 1year

    Comparison between post operative analegesia effect and side effect of dorsal penileblock and caudal block

Study contacts

Contact information is provided by the study sponsor or research team.

Mohammed Sayed abdelal, Assistant

CONTACT

[email protected]

01001204222

Soha Abdelhamid Fawzy, Resident

CONTACT

[email protected]

01061424208

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

Comparison Between Dorsal Nerve Block and Caudal Block Effect in Post Operative Pain in Hypospedius Repair in Children

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jul 15, 2024
Registry last updated
Jul 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.