Caudal vs Local Anesthesia for Hypospadias (CLASH Trial)

N/A

Recruiting

Led By Luis Braga, MD

Research Sponsored by McMaster University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up trial duration 1 year

Awards & highlights

No Placebo-Only Group

Summary

This trial will compare two different types of anesthesia used during surgery to correct a birth defect called hypospadias. The goal is to see if one type of anesthesia leads to more complications than the other.

Who is the study for?

This trial is for boys aged 6-48 months needing hypospadias repair by specialized pediatric urologists. It's not for those who've had previous surgery for hypospadias, can't follow the anesthesia plan, or whose guardians don't understand English/French.

What is being tested?

The study compares two types of anesthesia in young boys undergoing surgery for hypospadias: caudal block and dorsal penile block. The goal is to see if one leads to fewer surgical complications like fistulas or glans issues post-surgery.

What are the potential side effects?

While specific side effects are not listed, regional anesthetic techniques like caudal and dorsal penile blocks may include risks such as discomfort at the injection site, bleeding, infection, and nerve damage.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ trial duration 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~trial duration 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and trial duration 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Post-operative Complication Rate

Protocol violations or Adverse events

Recruitment rate

Secondary study objectives

Complications directly related to caudal block

Complications directly related to dorsal penile block

Operating Room (OR) time

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Caudal Block AnesthesiaExperimental Treatment1 Intervention

Anesthesia will be delivered via inhalation induction with air/nitrous oxide and sevoflurane, and injection of 0.25% bupivacaine 1mL/kg without epinephrine into the caudal canal, which is the sacral portion of the spinal canal.

Group II: Dorsal Penile Block AnesthesiaActive Control1 Intervention

Anesthesia will be delivered via inhalation induction with air/nitrous oxide and sevoflurane, and injection of 0.25% bupivacaine without epinephrine into the dorsal portion of the penis.

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