Caudal vs Local Anesthesia in Hypospadias

NCT ID: NCT02512887

Last Updated: 2023-03-15

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 224 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-07-31
• Study Completion Date: 2024-01-31

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.

Conditions

Hypospadias

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Caudal Block Anesthesia

Intervention Type: DRUG

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.

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.

Group Type: ACTIVE_COMPARATOR

Dorsal Penile Block Anesthesia

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

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.

Intervention Type: DRUG

Other Intervention Names

Local Anesthesia

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

• Minimum Eligible Age: 6 Months
• Maximum Eligible Age: 48 Months
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Canadian Urological Association

INDUSTRY

Sponsor Role: collaborator

McMaster University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Luis Braga, MD

Role: PRINCIPAL_INVESTIGATOR

McMaster University

Locations

McMaster Children's Hospital

Hamilton, Ontario, Canada

Site Status: RECRUITING

Children's Hospital, London Health Sciences Centre

London, Ontario, Canada

Site Status: NOT_YET_RECRUITING

Children's Hospital of Eastern Ontario

Ottawa, Ontario, Canada

Site Status: NOT_YET_RECRUITING

The Hospital for Sick Children

Toronto, Ontario, Canada

Site Status: NOT_YET_RECRUITING

Countries

Canada

Central Contacts

Luis Braga, MD

Role: CONTACT

braga@mcmaster.ca

905-521-2100 ext. 73777

Melissa McGrath

Role: CONTACT

mcgram2@mcmaster.ca

905-521-2100 ext. 73654

Facility Contacts

Luis Braga, MD

Role: primary

braga@mcmaster.ca

905-521-2100 ext. 73777

Sumit Dave

Role: primary

sumit.dave@lhsc.on.ca

519-685-8439

Luis Guerra, MD

Role: primary

lguerra@cheo.on.ca

613-737-7600 ext. 1353

Armando Lorenzo, MD

Role: primary

armando.lorenzo@sickkids.ca

416-813-1500 ext. 203109

Other Identifiers

CLASH

Identifier Type: -

Identifier Source: org_study_id