Caudal Block for Inguinal Hernioplasty in Children

Phase 3

Completed

• Conditions: Postoperative Pain
• Interventions: Drug: Caudal block with levobupivacaine; Drug: General anesthesia; Procedure: Inguinal hernioplasty

• Registration Number: NCT05958589
• Lead Sponsor: University of Novi Sad

Brief Summary

This is a prospective, randomized, controlled clinical study designed to determine the effectiveness of caudal block combined with general anesthesia in providing intra- and postoperative analgesia, and its effect on hemodynamic stability and drug consumption.

Detailed Description

This prospective, randomized, controlled clinical study will include 70 boys aged 3-5 years scheduled for inguinal herniorrhaphy. Participants will be randomized in 1:1 ratio into two groups. The first group will receive general anesthesia for surgery, while the second group will receive general anesthesia in combination with caudal block. Postoperative pain, hemodynamic parameters and total consumption of all medicaments in the perioperative period will be monitored. Complications and side effects of drugs will be observed as well.

Study Timeline

• Study Start: 2022-01-08
• Study First Submitted: 2023-07-07
• Study First Submitted QC: 2023-07-15
• Study First Posted: 2023-07-24
• Primary Completion: 2024-07-20
• Study Completion: 2024-07-20
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-03
• Last Update Posted: 2024-12-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 70

Inclusion Criteria

• boys between 3 to 5 years old
• scheduled for elective inguinal hernioplasty
• without comorbidities and chronic therapy, ASA class I
• body mass and growth normal for the given age
• no allergies
• no congenital anomalies and birth complications

Exclusion Criteria

• emergency surgeries
• surgeries longer than 60 minutes
• acute infections with leucocytosis/leucopenia
• acute or chronic diseases
• deformities and disorders of spine and nervous system
• allergies
• pilonidal cyst and/or inflammation in sacral region

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
General anesthesia + caudal block	Caudal block with levobupivacaine	General anesthesia with intravenous anesthetic propofol (2-3 mg/kg), opioid analgesic fentanyl (1-1.5 mcg/kg), and muscle relaxant rocuronium - bromide (0.6-1 mg/kg), in combination with a single shot caudal block with levobupivacaine 0.25% (2.5 mg/kg; maximal dose 75 mg).
General anesthesia + caudal block	Inguinal hernioplasty	General anesthesia with intravenous anesthetic propofol (2-3 mg/kg), opioid analgesic fentanyl (1-1.5 mcg/kg), and muscle relaxant rocuronium - bromide (0.6-1 mg/kg), in combination with a single shot caudal block with levobupivacaine 0.25% (2.5 mg/kg; maximal dose 75 mg).
General anesthesia	Inguinal hernioplasty	General anesthesia with intravenous anesthetic propofol (2-3 mg/kg), opioid analgesic fentanyl (1-1.5 mcg/kg), and muscle relaxant rocuronium - bromide (0.6-1 mg/kg)
General anesthesia	General anesthesia	General anesthesia with intravenous anesthetic propofol (2-3 mg/kg), opioid analgesic fentanyl (1-1.5 mcg/kg), and muscle relaxant rocuronium - bromide (0.6-1 mg/kg)
General anesthesia + caudal block	General anesthesia	General anesthesia with intravenous anesthetic propofol (2-3 mg/kg), opioid analgesic fentanyl (1-1.5 mcg/kg), and muscle relaxant rocuronium - bromide (0.6-1 mg/kg), in combination with a single shot caudal block with levobupivacaine 0.25% (2.5 mg/kg; maximal dose 75 mg).

Primary Outcome Measures

Name	Time	Method
Postoperative pain	5 hours	Postoperative pain level measured using the Wong-Baker Faces pain rating scale

Secondary Outcome Measures

Name	Time	Method
Blood pressure	5 hours	Noninvasive measurement of systolic and diastolic blood pressure
Heart rate	5 hours	Heart rate measured with electrocardiogram

Trial Locations

Locations (1)

Institute for health care of children and youth of Vojvodina; 🇷🇸 Novi Sad, Vojvodina, Serbia