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Clinical trial

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

ID
Name
05689/25-2
Description
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.
Trial arms
Trial start
2022-01-08
Estimated PCD
2025-01-01
Trial end
2025-12-01
Status
Recruiting
Phase
Early phase I
Treatment
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).
Arms:
General anesthesia + caudal block
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®).
Arms:
General anesthesia, General anesthesia + caudal block
Inguinal hernioplasty
Elective inguinal hernioplasty
Arms:
General anesthesia, General anesthesia + caudal block
Size
70
Primary endpoint
Postoperative pain
5 hours
Postoperative pain
5 hours
Eligibility criteria
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 70, 'type': 'ESTIMATED'}}
Updated at
2023-07-24

1 organization

2 products

1 indication

Organization
University of Novi Sad
Product
Caudal block with levobupivacaine
Indication
Postoperative Pain
Product
General anesthesia