Clinical trial NCT02512887: Caudal vs Local Anesthesia in Hypospadias
Official title: Caudal vs Local Anesthesia in Hypospadias: The CLASH Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hypospadias
Keywords: Hypospadias
Caudal Block
Dorsal Penile Block
Anesthesia
Complications
Post-operative
Urethrocutaneous Fistula
Glans dehiscence
Lead sponsor: McMaster University
Sponsor class: OTHER
Collaborators: name: Canadian Urological Association
First posted: 2015-07-31
Enrollment: 224
Sex: MALE
Minimum age (years): 6
Maximum age (years): 48
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Hypospadias is one of the most common congenital malformations of the genitalia in boys, and is typically managed by surgical intervention. During pediatric urological surgery, caudal anesthesia is one of the most common regional anesthetic techniques used. Also known as caudal block, it has been shown to be a safe and effective anesthetic technique in children with a low incidence of anesthesia-related complications.While the reported incidence of complications directly associated with caudal block is low, there is scarce and inconclusive evidence on the impact of caudal anesthesia on the incidence of surgical complications. As a result, the objective of this superiority, randomized controlled trial is to assess whether the use of caudal anesthesia, when compared to dorsal penile block, is associated with a higher rate of urethrocutaneous fistulas and glans dehiscence post hypospadias repair.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Post-operative Complication Rate
timeFrame: Follow-up to assess the complications, specifically urethrocutaneous fistula (UCF) and glans dehiscence within 12 months post-surgery.
measure: Recruitment rate
timeFrame: trial duration 1 year
measure: Protocol violations or Adverse events
timeFrame: trial duration 1 year
Secondary outcomes:
measure: Operating Room (OR) time
timeFrame: Record duration of operative time (takes on average 30-45 minutes)
measure: Complications directly related to caudal block
timeFrame: Complications will be measured at a clinic visit 48 hours after surgery.
measure: Complications directly related to dorsal penile block
timeFrame: Complications will be measured at a clinic visit 48 hours after surgery.
measure: Post-operative Pain
timeFrame: Measure at patient admission and discharge at 30 minute intervals.
measure: Post-operative Pain
timeFrame: Measure at patient admission and discharge at 30 minute intervals.
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: McMaster Children's Hospital
state: Ontario
city: London
country: Canada
facility: Children's Hospital, London Health Sciences Centre
state: Ontario
city: Ottawa
country: Canada
facility: Children's Hospital of Eastern Ontario
state: Ontario
city: Toronto
country: Canada
facility: The Hospital for Sick Children
state: Ontario
Study officials:
affiliation: McMaster University
name: Luis Braga, MD
role: PRINCIPAL_INVESTIGATOR
References: