HypospadiasNCT06417060
Caudal Anesthesia Versus Local Anesthesia in Hypospadias
A study testing Caudal block anesthesia and Dorsal penile block anesthesia in people with Hypospadias and Hypospadias, Coronal, run by Necmi Kadıoğlu Hospital at 3 sites in 3 countries.
Trial summary
Hypospadias is among the most common congenital genital malformations in boys and is typically treated through surgical intervention. During pediatric urological surgery, caudal anesthesia, also known as a caudal block, is frequently employed as a regional anesthetic technique. Read more about this study
- Who is it for?
- Ages 6 to 48 months, men only
- Conditions the study is for
- Hypospadias, Hypospadias, Coronal, Caudal Anesthesia
- What is being tested?
- Caudal block anesthesia and Dorsal penile block anesthesia
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 3 sitesin 3 countries
- Study dates
- 25 May 2023to 30 Aug 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
- Aged between 6 and 48 months
- Distal hypospadias
- Acceptance of participation
Who cannot join
- Midpenil hypospadias
- Proximal hypospadias
- Prior surgery
- Comorbidity (diabetes, hypertention, cardiac pathology)
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
North Macedonia1 site, 1 recruiting
- Recruiting
Ss. Cyril and Methodius University in Skopje, Pediatric Surgery, Skopje, Macedonia, the former Yugoslav Republic of North Macedonia
Skopje
Toni Risteski
Toni Risteski
Russia1 site, 1 recruiting
- Recruiting
Ao Gk Medsi
Moscow
Sergey Klyuev, MD
Sergey Klyuev, MD
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Necmi Kadioglu Esenyurt State Hospital
Istanbul, 34430
Mustafa Azizoğlu, +905447448244, mdmazizoglu@gmail.com
Mustafa Azizoglu, MD, PhD
About this study
Official title: THE IMPACT OF CAUDAL BLOCK ANESTHESIA ON POSTOPERATIVE COMPLICATIONS IN DISTAL HYPOSPADIAS SURGERY: A MULTI-CENTER RANDOMIZED CONTROLLED TRIAL
Hypospadias is among the most common congenital genital malformations in boys and is typically treated through surgical intervention. During pediatric urological surgery, caudal anesthesia, also known as a caudal block, is frequently employed as a regional anesthetic technique. It has proven to be a safe and effective anesthetic approach in children, with a low rate of anesthesia-related complications. However, despite the low incidence of complications directly associated with the caudal block, there is limited and inconclusive evidence regarding its impact on surgical complications. Therefore, this randomized controlled superiority trial aims to evaluate whether the use of caudal anesthesia, compared to the dorsal penile block, is associated with an increased incidence of urethrocutaneous fistulas and glans dehiscence following hypospadias repair.
Read the detailed description
The rationale for conducting a comprehensive study arises from the limitations inherent in existing literature, primarily due to selection bias and the retrospective nature of current evidence, which fails to clarify whether caudal blocks lead to higher complication rates after hypospadias repair. To fill this knowledge gap and address the clinical uncertainty surrounding this issue, the only effective approach is to randomly assign patients undergoing hypospadias repair to receive either caudal or penile block anesthesia. The purpose of this pilot study is to evaluate the feasibility of a definitive trial and identify any methodological issues that must be resolved before committing significant resources to a full-scale study.
This pilot study will assess the feasibility of conducting a large, definitive, parallel-group, randomized controlled trial (RCT) to determine whether a dorsal penile block results in fewer postoperative complications than a caudal block in boys aged 6 to 48 months undergoing hypospadias repair.
Hypospadias repair will be performed under standardized analgesic administration, and participants may receive fentanyl (1-3 mcg/kg) at the anesthesiologist's discretion. Anesthesia will be induced via inhalation of air/nitrous oxide and sevoflurane. Based on a randomized allocation, patients will receive either a caudal anesthetic block (0.25% bupivacaine, 1 ml/kg, up to a maximum of 10 ml) or a dorsal penile block (bupivacaine without epinephrine, 10-20 ml/kg). All patients will 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 discharge, patients will be prescribed oral morphine (0.2 mg/kg) every 4 hours as needed, Ditropan (0.2 mg/kg) every 12 hours as needed, Tylenol (15 mg/kg per dose) every 4 hours, or ibuprofen (10 mg/kg per dose) every 6 hours. Parents will administer these medications at their discretion. Trimethoprim (2 mg/kg) will also be prescribed until catheter removal.
- Conditions
- Hypospadias, Hypospadias, Coronal, Caudal Anesthesia, Children
- Being tested
- Caudal block anesthesia, Dorsal penile block anesthesia
- Keywords
- Hypospadias, Caudal anesthesia, Urethrocutanous fistula
- 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 administered via inhalation induction with air/nitrous oxide and sevoflurane, followed by an injection of 0.25% bupivacaine (1 mL/kg) without epinephrine into the caudal canal, which is the sacral portion of the spinal canal.
Dorsal penile block anesthesiaDrug
Anesthesia will be administered using an inhalation induction method with air/nitrous oxide and sevoflurane, followed by the injection of 0.25% bupivacaine without epinephrine into the dorsal part of the penis.
| Study group | Role | What they receive |
|---|---|---|
| Caudal block | Experimental | Anesthesia will be administered via inhalation induction with air/nitrous oxide and sevoflurane, followed by an injection of 0.25% bupivacaine (1 mL/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 | Sham comparator | Anesthesia will be administered using an inhalation induction method with air/nitrous oxide and sevoflurane, followed by the injection of 0.25% bupivacaine without epinephrine into the dorsal part 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
A urethrocutaneous fistula (UCF) is characterized by an abnormal connection between the reconstructed urethra and the skin, situated between the original meatus and the tip of the penis. Glans dehiscence refers to the complete separation of the glans wings, which may or may not be connected by a strip of skin.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2024
- Study start25 May 2023
- Primary completion29 Aug 2024 (estimated)
- Study completion30 Aug 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.
- 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Necmi Kadıoğlu Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mustafa Azizoğlu, Necmi Kadıoğlu Hospital
- Investigators
- Mustafa Azizoğlu, Principal investigator, Necmi Kadıoğlu State Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06417060
- Sponsor's protocol ID
- 2
- Status last verified
- Aug 2024
- First submitted
- 12 May 2024
- Last updated
- 20 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- THE IMPACT OF CAUDAL BLOCK ANESTHESIA ON POSTOPERATIVE COMPLICATIONS IN DISTAL HYPOSPADIAS SURGERY: A MULTI-CENTER RANDOMIZED CONTROLLED TRIAL
- ClinicalTrials.gov ID
- NCT06417060
- Acronym / sponsor ID
- 2
- Conditions
- Hypospadias, Hypospadias, Coronal, Caudal Anesthesia, Children
- Keywords
- Hypospadias, Caudal anesthesia, Urethrocutanous fistula
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Necmi Kadıoğlu HospitalUniversity, hospital or other
- Study start
- 25 May 2023 (actual)
- Primary completion
- 29 Aug 2024 (estimated)
- Study completion
- 30 Aug 2024 (estimated)
- First posted
- 16 May 2024 (actual)
- 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 among the most common congenital genital malformations in boys and is typically treated through surgical intervention. During pediatric urological surgery, caudal anesthesia, also known as a caudal block, is frequently employed as a regional anesthetic technique. It has proven to be a safe and effective anesthetic approach in children, with a low rate of anesthesia-related complications. However, despite the low incidence of complications directly associated with the caudal block, there is limited and inconclusive evidence regarding its impact on surgical complications. Therefore, this randomized controlled superiority trial aims to evaluate whether the use of caudal anesthesia, compared to the dorsal penile block, is associated with an increased incidence of urethrocutaneous fistulas and glans dehiscence following hypospadias repair.
Detailed description
The rationale for conducting a comprehensive study arises from the limitations inherent in existing literature, primarily due to selection bias and the retrospective nature of current evidence, which fails to clarify whether caudal blocks lead to higher complication rates after hypospadias repair. To fill this knowledge gap and address the clinical uncertainty surrounding this issue, the only effective approach is to randomly assign patients undergoing hypospadias repair to receive either caudal or penile block anesthesia. The purpose of this pilot study is to evaluate the feasibility of a definitive trial and identify any methodological issues that must be resolved before committing significant resources to a full-scale study.
This pilot study will assess the feasibility of conducting a large, definitive, parallel-group, randomized controlled trial (RCT) to determine whether a dorsal penile block results in fewer postoperative complications than a caudal block in boys aged 6 to 48 months undergoing hypospadias repair.
Hypospadias repair will be performed under standardized analgesic administration, and participants may receive fentanyl (1-3 mcg/kg) at the anesthesiologist's discretion. Anesthesia will be induced via inhalation of air/nitrous oxide and sevoflurane. Based on a randomized allocation, patients will receive either a caudal anesthetic block (0.25% bupivacaine, 1 ml/kg, up to a maximum of 10 ml) or a dorsal penile block (bupivacaine without epinephrine, 10-20 ml/kg). All patients will 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 discharge, patients will be prescribed oral morphine (0.2 mg/kg) every 4 hours as needed, Ditropan (0.2 mg/kg) every 12 hours as needed, Tylenol (15 mg/kg per dose) every 4 hours, or ibuprofen (10 mg/kg per dose) every 6 hours. Parents will administer these medications at their discretion. Trimethoprim (2 mg/kg) will also be prescribed until catheter removal.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Caudal block | Experimental | Drug: Caudal block anesthesiaAnesthesia will be administered via inhalation induction with air/nitrous oxide and sevoflurane, followed by an injection of 0.25% bupivacaine (1 mL/kg) without epinephrine into the caudal canal, which is the sacral portion of the spinal canal. |
| Dorsal Penile Block Anesthesia | Sham comparator | Drug: Dorsal penile block anesthesiaAnesthesia will be administered using an inhalation induction method with air/nitrous oxide and sevoflurane, followed by the injection of 0.25% bupivacaine without epinephrine into the dorsal part of the penis. |
Who may qualify
- Ages
- 6 to 48 months
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Aged between 6 and 48 months
- Distal hypospadias
- Acceptance of participation
Key exclusion criteria (4 listed)
- Midpenil hypospadias
- Proximal hypospadias
- Prior surgery
- Comorbidity (diabetes, hypertention, cardiac pathology)
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 administered via inhalation induction with air/nitrous oxide and sevoflurane, followed by an injection of 0.25% bupivacaine (1 mL/kg) without epinephrine into the caudal canal, which is the sacral portion of the spinal canal. | Drug | Caudal block |
| Dorsal penile block anesthesiaAnesthesia will be administered using an inhalation induction method with air/nitrous oxide and sevoflurane, followed by the injection of 0.25% bupivacaine without epinephrine into the dorsal part of the penis. | Drug | Dorsal Penile Block Anesthesia |
Primary outcome
Post-operative complication rate
Time frame: 1 year
A urethrocutaneous fistula (UCF) is characterized by an abnormal connection between the reconstructed urethra and the skin, situated between the original meatus and the tip of the penis. Glans dehiscence refers to the complete separation of the glans wings, which may or may not be connected by a strip of skin.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2024.
- Individual participant dataSharing planned: No
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.
Mustafa Azizoğlu principal investigator
Necmi Kadıoğlu State Hospital
3 sites in 3 countries: 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 and Hypospadias, Coronal, run by Necmi Kadıoğlu Hospital at 3 sites in 3 countries.
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 3 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 20 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in North Macedonia, Russia, Turkey (Türkiye). 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. Some participants in this study may receive a placebo. 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 Mustafa Azizoğlu, MD, PhD (+905447448244, mdmazizoglu@gmail.com), 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: 1 year). 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 20 Aug 2024.