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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

CLASH Trial 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.Check my eligibility
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.See study design
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.

CLASH Trial Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Post-operative Complication Rate
Protocol violations or Adverse events
Recruitment rate
Secondary outcome measures
Complications directly related to caudal block
Complications directly related to dorsal penile block
Operating Room (OR) time
+1 more

CLASH 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
881 Previous Clinical Trials
2,597,666 Total Patients Enrolled
Luis Braga, MDPrincipal InvestigatorMcMaster University
2 Previous Clinical Trials
262 Total Patients Enrolled

Media Library

Caudal Block Anesthesia (Local Anesthesia) Clinical Trial Eligibility Overview. Trial Name: NCT02512887 — N/A
Hypospadias Research Study Groups: Caudal Block Anesthesia, Dorsal Penile Block Anesthesia
Hypospadias Clinical Trial 2023: Caudal Block Anesthesia Highlights & Side Effects. Trial Name: NCT02512887 — N/A
Caudal Block Anesthesia (Local Anesthesia) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02512887 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many people are participating in this clinical trial?

"Correct. The information on clinicaltrials.gov suggests that this ongoing trial, which was first advertised in July 2016, is currently enrolling individuals for participation. 224 participants are expected to be recruited from 4 different sites."

Answered by AI

To whom is participation in this experiment open?

"This medical trial is seeking 224 participants, aged between 6 months and 48 months old, who are suffering from hypospadias."

Answered by AI

What is the extent of hospital involvement with this research endeavor?

"Presently, this study is enrolling patients at 4 locations; London, Toronto, and Ottawa as well as a quartet of additional sites. To reduce travel demands for those who take part in the trial it might be beneficial to select the closest location."

Answered by AI

What is the primary aim of this clinical assessment?

"According to the Canadian Urological Association, this clinical trial's main objective is evaluating Post-operative Complication Rate over a 1 year period. This study will also consider secondary outcomes such as complications stemming from caudal block failure, blood aspiration and intravascular injections, Operating Room time measured in minutes from patient entry until surgery completion; additionally pain scores assessed through Children’s Hospital of Eastern Ontario Pain Scale (CHEOPS) by two trained independent observers at admission and discharge during recovery phase.."

Answered by AI

Does this research encompass participants beyond the age of seventy-five?

"To participate in this trial, subjects must be between 6 months and 48 months old. The study also has a seperate arm for minors (13 spots) and geriatric patients (4 slots)."

Answered by AI

Is recruitment for this study still open?

"Affirmative. Clinicaltrials.gov data reveals that this trial, initially posted on July 1st 2016, is actively seeking participants. 224 individuals from 4 distinct medical sites are required for successful completion of the study."

Answered by AI
~26 spots leftby Apr 2025