NCT05958589

Caudal Block for Inguinal Hernioplasty in Children

Efficacy and Safety of General Anesthesia With Caudal Block for Inguinal Hernioplasty in Children: a Randomized Controlled Trial

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 70 (actual)
• Sponsor: University of Novi Sad · Academic / Other
• Sex: Male
• Age: 3 Years – 5 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Postoperative Pain

Interventions

Type	Name	Description
DRUG	Caudal block with levobupivacaine	After the introduction of general anesthesia, a single shot caudal block will be performed with levobupivacaine 0.25% (2.5 mg/kg; maximal dose 75 mg).
DRUG	General anesthesia	On the day of operation all patients will recieve midazolam 0.5 mg/kg (maximum dose 15 mg) orally. Induction of anesthesia will be the same for all patients and consist of 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). The airway will be obtained by placing a laryngeal mask (I-gel®).
PROCEDURE	Inguinal hernioplasty	Elective inguinal hernioplasty

Timeline

• Start date: 2022-01-08
• Primary completion: 2024-07-20
• Completion: 2024-07-20
• First posted: 2023-07-24
• Last updated: 2024-12-04

Locations

1 site across 1 country: Serbia