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Local Anesthesia
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
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 moreAwards & 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.
Find a Location
Who is running the clinical trial?
Canadian Urological AssociationIndustry Sponsor
7 Previous Clinical Trials
393 Total Patients Enrolled
McMaster UniversityLead Sponsor
917 Previous Clinical Trials
2,616,130 Total Patients Enrolled
Luis Braga, MDPrincipal InvestigatorMcMaster University
2 Previous Clinical Trials
262 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You had a surgery in the past for hypospadias.You are unable to have a caudal or dorsal penile block due to medical reasons.
Research Study Groups:
This trial has the following groups:- Group 1: Caudal Block Anesthesia
- Group 2: Dorsal Penile Block Anesthesia
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.