Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT06417060 |
| Other study ID # |
2 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
May 25, 2023 |
| Est. completion date |
May 26, 2024 |
Study information
| Verified date |
May 2024 |
| Source |
Necmi Kadioglu Hospital |
| Contact |
Mustafa Azizoglu, MD, PhD |
| Phone |
+905447448244 |
| Email |
mdmazizoglu[@]gmail.com |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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. 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.
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.
