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Caudal Block for Inguinal Hernioplasty in Children

NCT05958589 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2024-12-04

No results posted yet for this study

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.

Conditions

  • Postoperative Pain

Interventions

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

Sponsors & Collaborators

  • University of Novi Sad

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
3 Years
Max Age
5 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-08
Primary Completion
2024-07-20
Completion
2024-07-20

Countries

  • Serbia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05958589 on ClinicalTrials.gov