Efficacy and Safety of General Anesthesia With Caudal Block for Inguinal Hernioplasty in Children: a Randomized Controlled Trial
Overview
- Phase
- Phase 3
- Intervention
- Caudal block with levobupivacaine
- Conditions
- Postoperative Pain
- Sponsor
- University of Novi Sad
- Enrollment
- 70
- Locations
- 1
- Primary Endpoint
- Postoperative pain
- Status
- Completed
- Last Updated
- last year
Overview
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.
Investigators
Mihaela Preveden
Research Assistant
University of Novi Sad
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
Arms & Interventions
General anesthesia + caudal block
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).
Intervention: Caudal block with levobupivacaine
General anesthesia + caudal block
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).
Intervention: General anesthesia
General anesthesia + caudal block
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).
Intervention: Inguinal hernioplasty
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)
Intervention: 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)
Intervention: Inguinal hernioplasty
Outcomes
Primary Outcomes
Postoperative pain
Time Frame: 5 hours
Postoperative pain level measured using the Wong-Baker Faces pain rating scale
Secondary Outcomes
- Blood pressure(5 hours)
- Heart rate(5 hours)