HypospadiasCLASHNCT02512887
Caudal vs Local Anesthesia in Hypospadias
A study testing Caudal Block Anesthesia and Dorsal Penile Block Anesthesia in people with Hypospadias, run by McMaster University at 4 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 48 months, men only
- Conditions the study is for
- Hypospadias
- What is being tested?
- Caudal Block Anesthesia and Dorsal Penile Block Anesthesia
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 224 participants
- Where
- 4 sitesCanada
- Study dates
- Jul 2016to Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 48 months
- Men only
- No healthy volunteers
- Child
Who may be able to join
- Males 6-48 months of age at presentation to Pediatric Urology clinics
- Patient who requires hypospadias repair by fellowship-trained Pediatric Urologists.
Who cannot join
- 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
Trial locations and contacts
4 sites in 1 country.
Canada4 sites, 4 recruiting
- Recruiting
McMaster Children's Hospital
Hamilton, Ontario, L8N 3Z5
Luis Braga, MD, 905-521-2100 ext. 73777, braga@mcmaster.ca
- Not yet recruiting
Children's Hospital, London Health Sciences Centre
London, Ontario, N6A 5W9
Sumit Dave, 519-685-8439, sumit.dave@lhsc.on.ca
- Not yet recruiting
Children's Hospital of Eastern Ontario
Ottawa, Ontario, K1H 8L1
Luis Guerra, MD, 613-737-7600 ext. 1353, lguerra@cheo.on.ca
- Not yet recruiting
The Hospital for Sick Children
Toronto, Ontario, M5G 1X8
Armando Lorenzo, MD, 416-813-1500 ext. 203109, armando.lorenzo@sickkids.ca
About this study
Official title: Caudal vs Local Anesthesia in Hypospadias: The CLASH Study
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.
Read the 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
- Being tested
- Caudal Block Anesthesia, Dorsal Penile Block Anesthesia
- Keywords
- Hypospadias, Caudal Block, Dorsal Penile Block, Anesthesia, Complications, Post-operative, Urethrocutaneous Fistula, Glans dehiscence
- Medical subject headings
- Hypospadias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Caudal Block AnesthesiaDrug
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 AnesthesiaDrug
Also called Local 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.
| Study group | Role | What they receive |
|---|---|---|
| Caudal Block Anesthesia | Experimental | 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. Receives: Drug: Caudal Block Anesthesia |
| Dorsal Penile Block Anesthesia | Active comparator | 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. Receives: Drug: Dorsal Penile Block Anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-operative Complication Rate
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.
Measured: Follow-up to assess the complications, specifically urethrocutaneous fistula (UCF) and glans dehiscence within 12 months post-surgery.
Recruitment rate
Percentage of eligible participants enrolled, Randomization rate (percentage of enrolled participants randomized)
Measured: trial duration 1 year
Protocol violations or Adverse events
Frequency of protocol violations or adverse events related to the study intervention.
Measured: trial duration 1 year
Secondary outcomes (5)
Operating Room (OR) time
OR time will be measured in minutes from the time the patient enters the OR to the time surgery is complete
Measured: Record duration of operative time (takes on average 30-45 minutes)
Complications directly related to caudal block
Complications directly related to caudal block include block failure, blood aspiration and intravascular injections.
Measured: Complications will be measured at a clinic visit 48 hours after surgery.
Complications directly related to dorsal penile block
Complications directly related to dorsal penile block include hematoma and intravascular injection.
Measured: Complications will be measured at a clinic visit 48 hours after surgery.
Post-operative Pain
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.
Measured: Measure at patient admission and discharge at 30 minute intervals.
Post-operative Pain
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.
Measured: Measure at patient admission and discharge at 30 minute intervals.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2015 (estimated)
- Study startJul 2016
- Primary completionJan 2024 (estimated)
- Study completionJan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypospadiasStudies of the same condition, open and under way.
- More trials run by McMaster UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 224 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Urological Association
- Responsible party
- Sponsor
- Investigators
- Luis Braga, MD, Principal investigator, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02512887
- Sponsor's protocol ID
- CLASH
- Acronym
- CLASH
- Status last verified
- Mar 2023
- First submitted
- 27 Jul 2015
- Last updated
- 15 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Caudal vs Local Anesthesia in Hypospadias: The CLASH Study
- ClinicalTrials.gov ID
- NCT02512887
- Acronym / sponsor ID
- CLASH / CLASH
- Conditions
- Hypospadias
- Keywords
- Hypospadias, Caudal Block, Dorsal Penile Block, Anesthesia, Complications, Post-operative, Urethrocutaneous Fistula, Glans dehiscence
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 224 participants (estimated)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Collaborators
- Canadian Urological Association
- Study start
- Jul 2016
- Primary completion
- Jan 2024 (estimated)
- Study completion
- Jan 2024 (estimated)
- First posted
- 31 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Caudal Block Anesthesia | Experimental | Drug: Caudal Block AnesthesiaAnesthesia 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 | Active comparator | Drug: Dorsal Penile Block AnesthesiaAnesthesia 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. |
Who may qualify
- Ages
- 6 to 48 months
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Males 6-48 months of age at presentation to Pediatric Urology clinics
- Patient who requires hypospadias repair by fellowship-trained Pediatric Urologists.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Caudal Block AnesthesiaAnesthesia 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 |
| Dorsal Penile Block AnesthesiaAlso: Local AnesthesiaAnesthesia 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 |
Primary outcome
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.
Recruitment rate
Time frame: trial duration 1 year
Percentage of eligible participants enrolled, Randomization rate (percentage of enrolled participants randomized)
Protocol violations or Adverse events
Time frame: trial duration 1 year
Frequency of protocol violations or adverse events related to the study intervention.
5 secondary outcomes
Operating Room (OR) time
Time frame: 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 dorsal penile block
Time frame: Complications will be measured at a clinic visit 48 hours after surgery.
Post-operative Pain
Time frame: 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2023.
Related trials for Hypospadias
Not yet recruitingPhase 4
Effect of Oxybutynin on Opioid Use After Urologic Surgery in Children
Ureteropelvic Junction Obstruction, Hypospadias
Recruiting
Worldwide Yearly Screening for Hypospadias
Hypospadias
Not yet recruitingPhase 4
Emerging Indications for Hyperbaric Oxygen Treatment
Post-COVID-19 Condition, Ulcerative Colitis
Active, not recruiting
Evaluating the Efficacy and Safety of Tranexamic Acid in Reducing Perioperative Bleeding During Recurrent Hypospadias Repair.
Perioperative Bleeding During Recurrent Hypospadias Repair
Not yet recruiting
Efficacy of PRF in Hypospadias Repair
Hypospadias
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Luis Braga, MD principal investigator
McMaster University
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Caudal Block Anesthesia and Dorsal Penile Block Anesthesia in people with Hypospadias, run by McMaster University at 4 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Luis Braga, MD (905-521-2100 ext. 73777, braga@mcmaster.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-operative Complication Rate (time frame: Follow-up to assess the complications, specifically urethrocutaneous fistula (UCF) and glans dehiscence within 12 months post-surgery.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2023.