Comparison of Caudal Block Combined With General Anesthesia and Penile Block and Intravenous Fentanyl in Pediatric Surgeries

NCT ID: NCT06862271

Last Updated: 2025-03-11

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-01
• Study Completion Date: 2025-07-15

Brief Summary

Urogenital surgery is one of the most frequently performed surgical procedures in the pediatric patient population. There is no consensus on which analgesic method is most effective for pain control in these patients. In clinical practice, if there are no contraindications, caudal block or penile block combined with intravenous fentanyl can be preferred as an analgesic method.

In this study, the results of these two analgesia methods will be compared with the research.Randomly selected participants will be compared by looking at parameters such as postoperative questionnaire results, walking time and urination time.

Conditions

Caudal Block; Pediatric Urologic Surgeries; Fentanyl; Pediatric Delirium; Analgesia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Group 1 ( Caudal block group )

In the caudal block group, after the induction of caudal block with investigations, 0.2% bupivacaine will be applied to the epidural space in a volume of 0.8 mL/kg and a maximum of 20 mL will be injected into the epidural space and the surgical incision will be made at the 15th minute.

Group Type: ACTIVE_COMPARATOR

Group 1 ( Caudal block group )

Intervention Type: PROCEDURE

In the caudal block group, after the induction of caudal block with investigations, 0.2% bupivacaine will be applied to the epidural space in a volume of 0.8 mL/kg and a maximum of 20 mL will be injected into the epidural space and the surgical incision will be made at the 15th minute. For participants after surgery, Pediatric Anesthesia Emergence Delirium (PAED), Face Leg Activity Cry Consolability (FLACC) scales will be recorded, and for parental satisfaction, the LIKERT scale will be used. In addition, the child's walking time, first urination time, and need for additional painkillers will be questioned and recorded.

Group 2 (Penile block and IV Fentanyl group)

In the penile block and IV fentanyl group, 1 µg/kg fentanyl will be administered by the investigations and 5 minutes later, penile block will be performed using 0.25% bupivacaine at a dose of 0.2 mL/kg.

Group Type: ACTIVE_COMPARATOR

Group 2 (Penile block and IV Fentanyl group)

Intervention Type: PROCEDURE

In the penile block and IV fentanyl group, 1 µg/kg fentanyl will be administered by the investigations and 5 minutes later, penile block will be performed using 0.25% bupivacaine at a dose of 0.2 mL/kg. For participants after surgery, Pediatric Anesthesia Emergence Delirium (PAED), Face Leg Activity Cry Consolability (FLACC) scales will be recorded, and for parental satisfaction, the LIKERT scale will be used. In addition, the child's walking time, first urination time, and need for additional painkillers will be questioned and recorded.

Interventions

Group 1 ( Caudal block group )

In the caudal block group, after the induction of caudal block with investigations, 0.2% bupivacaine will be applied to the epidural space in a volume of 0.8 mL/kg and a maximum of 20 mL will be injected into the epidural space and the surgical incision will be made at the 15th minute. For participants after surgery, Pediatric Anesthesia Emergence Delirium (PAED), Face Leg Activity Cry Consolability (FLACC) scales will be recorded, and for parental satisfaction, the LIKERT scale will be used. In addition, the child's walking time, first urination time, and need for additional painkillers will be questioned and recorded.

Intervention Type: PROCEDURE

Group 2 (Penile block and IV Fentanyl group)

In the penile block and IV fentanyl group, 1 µg/kg fentanyl will be administered by the investigations and 5 minutes later, penile block will be performed using 0.25% bupivacaine at a dose of 0.2 mL/kg. For participants after surgery, Pediatric Anesthesia Emergence Delirium (PAED), Face Leg Activity Cry Consolability (FLACC) scales will be recorded, and for parental satisfaction, the LIKERT scale will be used. In addition, the child's walking time, first urination time, and need for additional painkillers will be questioned and recorded.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• 4 months - 12 years old male patient
• Acceptance of participation in the study
• Patients Planned for Urogenital Surgery
• ASA I-II Patients

Exclusion Criteria

• <4 months, >12 years male patient
• Female patient
• Not accepted to be included in the study
• ASA status III-IV
• History of bleeding disorder
• Spinal cord disease
• Obstructive sleep apnea
• Developmental delay
• Behavioral disorder
• Allergy to any drug in the protocol

• Minimum Eligible Age: 4 Months
• Maximum Eligible Age: 12 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Miray Gözde Özdemir

OTHER_GOV

Sponsor Role: lead

Responsible Party

Miray Gözde Özdemir

Specialist / Doctor

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Ankara Etlik City Hospital

Yenimahalle, Ankara, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Central Contacts

Miray G Özdemir, MD

Role: CONTACT

miraygozdebinzet@gmail.com

+905347816151

Facility Contacts

Miray Gözde Özdemir, MD

Role: primary

miraygozdebinzet@gmail.com

05347816151

Other Identifiers

102

Identifier Type: -

Identifier Source: org_study_id