## Protocol Section
### Identification Module
**NCT ID:** NCT06417060

**Brief Title:** Caudal Anesthesia Versus Local Anesthesia in Hypospadias

**Official Title:** THE IMPACT OF CAUDAL BLOCK ANESTHESIA ON POSTOPERATIVE COMPLICATIONS IN DISTAL HYPOSPADIAS SURGERY: A MULTI-CENTER RANDOMIZED CONTROLLED TRIAL

#### Organization Study ID Info
**ID:** 2
#### Organization
**Class:** OTHER
**Full Name:** Necmi Kadıoğlu Hospital
### Status Module
#### Completion Date
**Date:** 2024-05-26

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-16

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-12

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2024-05-25

**Type:** ESTIMATED

#### Start Date
**Date:** 2023-05-25

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-16
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-12
**Study First Submit QC Date:** 2024-05-12
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Necmi Kadıoğlu Hospital

#### Responsible Party

**Investigator Affiliation:** Necmi Kadıoğlu Hospital

**Investigator Full Name:** Mustafa Azizoğlu

**Investigator Title:** MD

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** True

### Description Module

**Brief 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.

**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 Module

**Conditions:**

- Hypospadias

- Hypospadias, Coronal

- Caudal Anesthesia

- Children

**Keywords:**

- Hypospadias

- Caudal anesthesia

- Urethrocutanous fistula

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** DOUBLE

**Masking Description:** participant and outcome assessor

**Who Masked:**

- PARTICIPANT

- OUTCOMES_ASSESSOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 200

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** 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.

**Intervention Names:**

- Drug: Caudal block anesthesia

**Label:** Caudal block

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** 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.

**Intervention Names:**

- Drug: Dorsal penile block anesthesia

**Label:** Dorsal Penile Block Anesthesia

**Type:** SHAM_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Caudal block

**Description:** 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.

**Name:** Caudal block anesthesia

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- Dorsal Penile Block Anesthesia

**Description:** 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.

**Name:** Dorsal penile block anesthesia

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** 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.

**Measure:** Post-operative complication rate

**Time Frame:** 1 year

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Aged between 6 and 48 months
* Distal hypospadias
* Acceptance of participation

Exclusion Criteria:

* Midpenil hypospadias
* Proximal hypospadias
* Prior surgery
* Comorbidity (diabetes, hypertention, cardiac pathology)

**Maximum Age:** 48 Months

**Minimum Age:** 6 Months

**Sex:** MALE

**Standard Ages:**

- CHILD

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** mdmazizoglu@gmail.com

**Name:** Mustafa Azizoğlu, MD, PhD

**Phone:** +905447448244

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Skopje

**Contacts:**

***Contact 1:***

- **Name:** Toni Risteski

- **Role:** CONTACT

***Contact 2:***

- **Name:** Toni Risteski

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** North Macedonia

**Facility:** Ss. Cyril and Methodius University in Skopje, Pediatric Surgery, Skopje, Macedonia, the former Yugoslav Republic of North Macedonia

**Status:** RECRUITING

**Location 2:**

**City:** Moscow

**Contacts:**

***Contact 1:***

- **Name:** Sergey Klyuev, MD

- **Role:** CONTACT

***Contact 2:***

- **Name:** Sergey Klyuev, MD

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** Russian Federation

**Facility:** Ao Gk Medsi

**Status:** RECRUITING

**Location 3:**

**City:** Istanbul

**Contacts:**

***Contact 1:***

- **Email:** mdmazizoglu@gmail.com

- **Name:** Mustafa Azizoğlu

- **Phone:** +905447448244

- **Role:** CONTACT

***Contact 2:***

- **Name:** Mustafa Azizoglu, MD, PhD

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** Turkey

**Facility:** Necmi Kadioglu Esenyurt State Hospital

**Status:** RECRUITING

**Zip:** 34430

#### Overall Officials

**Official 1:**

**Affiliation:** Necmi Kadıoğlu State Hospital

**Name:** Mustafa Azizoğlu

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000014564

- Term: Urogenital Abnormalities

- ID: D000052776

- Term: Female Urogenital Diseases

- ID: D000005261

- Term: Female Urogenital Diseases and Pregnancy Complications

- ID: D000091642

- Term: Urogenital Diseases

- ID: D000010409

- Term: Penile Diseases

- ID: D000005832

- Term: Genital Diseases, Male

- ID: D000091662

- Term: Genital Diseases

- ID: D000052801

- Term: Male Urogenital Diseases

- ID: D000000013

- Term: Congenital Abnormalities

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BXS

- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions

- Abbrev: BC16

- Name: Diseases and Abnormalities at or Before Birth

### Condition Browse Module - Browse Leaves

- ID: M14065

- Name: Postoperative Complications

- Relevance: LOW

- As Found: Unknown

- ID: M8532

- Name: Fistula

- Relevance: LOW

- As Found: Unknown

- ID: M10071

- Name: Hypospadias

- Relevance: HIGH

- As Found: Hypospadias

- ID: M12

- Name: Congenital Abnormalities

- Relevance: LOW

- As Found: Unknown

- ID: M17314

- Name: Urogenital Abnormalities

- Relevance: LOW

- As Found: Unknown

- ID: M2875

- Name: Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M27093

- Name: Female Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14127

- Name: Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

- ID: M8399

- Name: Female Urogenital Diseases and Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

- ID: M13320

- Name: Penile Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M2876

- Name: Genital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M8944

- Name: Genital Diseases, Male

- Relevance: LOW

- As Found: Unknown

- ID: M27095

- Name: Male Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000007021

- Term: Hypospadias

### Intervention Browse Module - Ancestors

- ID: D000002492

- Term: Central Nervous System Depressants

- ID: D000045505

- Term: Physiological Effects of Drugs

### Intervention Browse Module - Browse Branches

- Abbrev: CNSDep

- Name: Central Nervous System Depressants

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: Analg

- Name: Analgesics

- Abbrev: VaCoAg

- Name: Vasoconstrictor Agents

- Abbrev: Resp

- Name: Respiratory System Agents

- Abbrev: PlAggInh

- Name: Platelet Aggregation Inhibitors

### Intervention Browse Module - Browse Leaves

- ID: M5315

- Name: Bupivacaine

- Relevance: LOW

- As Found: Unknown

- ID: M4107

- Name: Anesthetics

- Relevance: HIGH

- As Found: Imaging

- ID: M12546

- Name: Nitrous Oxide

- Relevance: LOW

- As Found: Unknown

- ID: M7992

- Name: Epinephrine

- Relevance: LOW

- As Found: Unknown

- ID: M1673

- Name: Sevoflurane

- Relevance: LOW

- As Found: Unknown

- ID: M30371

- Name: Racepinephrine

- Relevance: LOW

- As Found: Unknown

- ID: M211043

- Name: Epinephryl borate

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000000777

- Term: Anesthetics

### Misc Info Module

- Version Holder: 2024-05-31
