- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02512887
Caudal vs Local Anesthesia in Hypospadias (CLASH)
Caudal vs Local Anesthesia in Hypospadias: The CLASH Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The rationale to conduct a definitive study comes as a result of the limitations inherent in the pre-existing literature due to selection bias, and the primarily retrospective nature of the current evidence, which is unclear whether caudal blocks result in higher complication rates following hypospadias repair. The only way to close this knowledge gap and disturb the current state of clinical equipoise surrounding this topic is to randomly assign the two interventions (caudal or penile block) to patients undergoing hypospadias repair. The rationale to conduct this pilot study is to determine whether the definitive study is feasible and to ensure that any methodological issues are identified and addressed prior to investing significant resources in a definitive trial.
This study will be a pilot study to determine the feasibility of conducting a large definitive superiority, parallel, randomized controlled trial (RCT) to assess whether dorsal penile block results in fewer postoperative complications than caudal block in boys (6-48 mos.) undergoing hypospadias repair.
Hypospadias repair will be carried out under standardized analgesic administration.. Participants may be given fentanyl (1-3 mcg/kg) at the discretion of the anesthesiologist. Anesthesia will be delivered to all participants via inhalation induction with air/nitrous oxide and sevoflurane. In addition either caudal anesthetic block (0.25% bupivacaine 1 ml/kg to a maximum of 10 ml) or dorsal penile block (bupivacaine without epinephrine 10-20 ml/kg) will be administered based on our randomization scheme. Each patient will also receive antiemetic prophylaxis with dexamethasone 150 mcg/kg ondansetron 50 mcg/kg Acetaminophen suppository 40 mg/kg, and intravenous morphine (0.02-0.1 mg/kg).
At Home At home, Oral Morphine (0.2 mg/kg) q4h prn, Ditropan (0.2 mg/kg) q12h prn, Tylenol (15 mg/kg/dose) q4h or Ibuprofen (10 mg/kg/dose) q6h will be prescribed at discharge to be administered at the parents' discretion. Trimethoprim (2 mg/kg) will also be prescribed for administration until catheter removal.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Ontario
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Hamilton, Ontario, Canada, L8N 3Z5
- Recruiting
- McMaster Children's Hospital
-
London, Ontario, Canada, N6A 5W9
- Not yet recruiting
- Children's Hospital, London Health Sciences Centre
-
Contact:
- Sumit Dave
- Phone Number: 519-685-8439
- Email: sumit.dave@lhsc.on.ca
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Ottawa, Ontario, Canada, K1H 8L1
- Not yet recruiting
- Children's Hospital of Eastern Ontario
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Contact:
- Luis Guerra, MD
- Phone Number: 1353 613-737-7600
- Email: lguerra@cheo.on.ca
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Toronto, Ontario, Canada, M5G 1X8
- Not yet recruiting
- The Hospital for Sick Children
-
Contact:
- Armando Lorenzo, MD
- Phone Number: 203109 416-813-1500
- Email: armando.lorenzo@sickkids.ca
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Males 6-48 months of age at presentation to Pediatric Urology clinics
- Patient who requires hypospadias repair by fellowship-trained Pediatric Urologists.
Exclusion Criteria:
- Patients who have undergone previous hypospadias surgery
- Patients who have contraindications to either caudal or dorsal penile block
- Inability of parent/guardian to understand English/French
- Deviation to pre-established anesthesia protocol
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Caudal Block Anesthesia
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.
|
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.
|
Active Comparator: Dorsal Penile Block Anesthesia
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.
|
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.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Post-operative Complication Rate
Time Frame: Follow-up to assess the complications, specifically urethrocutaneous fistula (UCF) and glans dehiscence within 12 months post-surgery.
|
UCF is defined as an abnormal communication between the reconstructed urethra and the skin located between the original meatus and the tip of the penis.Glans dehiscence is considered as a complete separation of the glans wings with or without a band of skin between them.
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Follow-up to assess the complications, specifically urethrocutaneous fistula (UCF) and glans dehiscence within 12 months post-surgery.
|
Recruitment rate
Time Frame: trial duration 1 year
|
Percentage of eligible participants enrolled, Randomization rate (percentage of enrolled participants randomized)
|
trial duration 1 year
|
Protocol violations or Adverse events
Time Frame: trial duration 1 year
|
Frequency of protocol violations or adverse events related to the study intervention.
|
trial duration 1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Operating Room (OR) time
Time Frame: Record duration of operative time (takes on average 30-45 minutes)
|
OR time will be measured in minutes from the time the patient enters the OR to the time surgery is complete
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Record duration of operative time (takes on average 30-45 minutes)
|
Complications directly related to caudal block
Time Frame: Complications will be measured at a clinic visit 48 hours after surgery.
|
Complications directly related to caudal block include block failure, blood aspiration and intravascular injections.
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Complications will be measured at a clinic visit 48 hours after surgery.
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Complications directly related to dorsal penile block
Time Frame: Complications will be measured at a clinic visit 48 hours after surgery.
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Complications directly related to dorsal penile block include hematoma and intravascular injection.
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Complications will be measured at a clinic visit 48 hours after surgery.
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Post-operative Pain
Time Frame: Measure at patient admission and discharge at 30 minute intervals.
|
Pain scores will be measured through a reliable and validated observer-rated Face, Legs, Activity, Cry, Consolability (FLACC) Behavioural Scale by two trained, blinded, and independent study personnel.
Both study personnel will measure pain at admission and discharge during the recovery phase.
|
Measure at patient admission and discharge at 30 minute intervals.
|
Post-operative Pain
Time Frame: Measure at patient admission and discharge at 30 minute intervals.
|
Pain scores will be measured through a reliable and validated observer-rated Children's Hospital of Eastern Ontario Pain Scale (CHEOPS) by two trained, blinded, and independent study personnel.
Both study personnel will measure pain at admission and discharge during the recovery phase.
|
Measure at patient admission and discharge at 30 minute intervals.
|
Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CLASH
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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