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Trial record 7 of 31 for:    Recruiting, Not yet recruiting, Available Studies | "Penile Diseases"

Caudal vs Local Anesthesia in Hypospadias (CLASH)

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ClinicalTrials.gov Identifier: NCT02512887
Recruitment Status : Recruiting
First Posted : July 31, 2015
Last Update Posted : March 14, 2018
Sponsor:
Collaborator:
Canadian Urological Association
Information provided by (Responsible Party):
McMaster University

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.

Condition or disease Intervention/treatment Phase
Hypospadias Drug: Caudal Block Anesthesia Drug: Dorsal Penile Block Anesthesia Not Applicable

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 : Interventional  (Clinical Trial)
Estimated Enrollment : 224 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Caudal vs Local Anesthesia in Hypospadias: The CLASH Study
Study Start Date : July 2016
Estimated Primary Completion Date : August 2019
Estimated Study Completion Date : August 2019

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.
Drug: 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.

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.
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.
Other Name: Local Anesthesia




Primary Outcome Measures :
  1. 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.

  2. Recruitment rate [ Time Frame: trial duration 1 year ]
    Percentage of eligible participants enrolled, Randomization rate (percentage of enrolled participants randomized)

  3. Protocol violations or Adverse events [ Time Frame: trial duration 1 year ]
    Frequency of protocol violations or adverse events related to the study intervention.


Secondary Outcome Measures :
  1. 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

  2. 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.

  3. Complications directly related to dorsal penile block [ Time Frame: Complications will be measured at a clinic visit 48 hours after surgery. ]
    Complications directly related to dorsal penile block include hematoma and intravascular injection.

  4. 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.

  5. 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.



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Ages Eligible for Study:   6 Months to 48 Months   (Child)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02512887


Contacts
Contact: Luis Braga, MD 905-521-2100 ext 73777 braga@mcmaster.ca
Contact: Melissa McGrath 905-521-2100 ext 73654 mcgram2@mcmaster.ca

Locations
Canada, Ontario
McMaster Children's Hospital Recruiting
Hamilton, Ontario, Canada, L8N 3Z5
Contact: Luis Braga, MD    905-521-2100 ext 73777    braga@mcmaster.ca   
Children's Hospital, London Health Sciences Centre Not yet recruiting
London, Ontario, Canada, N6A 5W9
Contact: Sumit Dave    519-685-8439    sumit.dave@lhsc.on.ca   
Children's Hospital of Eastern Ontario Not yet recruiting
Ottawa, Ontario, Canada, K1H 8L1
Contact: Luis Guerra, MD    613-737-7600 ext 1353    lguerra@cheo.on.ca   
The Hospital for Sick Children Not yet recruiting
Toronto, Ontario, Canada, M5G 1X8
Contact: Armando Lorenzo, MD    416-813-1500 ext 203109    armando.lorenzo@sickkids.ca   
Sponsors and Collaborators
McMaster University
Canadian Urological Association
Investigators
Principal Investigator: Luis Braga, MD McMaster University

Additional Information:
Responsible Party: McMaster University
ClinicalTrials.gov Identifier: NCT02512887     History of Changes
Other Study ID Numbers: CLASH
First Posted: July 31, 2015    Key Record Dates
Last Update Posted: March 14, 2018
Last Verified: August 2017

Keywords provided by McMaster University:
Hypospadias
Caudal Block
Dorsal Penile Block
Anesthesia
Complications
Post-operative
Urethrocutaneous Fistula
Glans dehiscence

Additional relevant MeSH terms:
Penile Diseases
Hypospadias
Genital Diseases, Male
Urogenital Abnormalities
Congenital Abnormalities
Anesthetics
Bupivacaine
Sevoflurane
Nitrous Oxide
Epinephrine
Racepinephrine
Epinephryl borate
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Local
Sensory System Agents
Peripheral Nervous System Agents
Platelet Aggregation Inhibitors
Anesthetics, Inhalation
Anesthetics, General
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic beta-Agonists
Bronchodilator Agents
Autonomic Agents
Anti-Asthmatic Agents
Respiratory System Agents