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

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.

Study Overview

• Status: Completed
• Conditions: Postoperative Pain
• Intervention / Treatment: Drug: Caudal block with levobupivacaine; Drug: General anesthesia; Procedure: Inguinal hernioplasty

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 Type: Interventional
• Enrollment (Actual): 70
• Phase: Phase 3

Contacts and Locations

Study Locations

• Serbia
  • Vojvodina
    • Novi Sad, Vojvodina, Serbia, 21000
      • Institute for health care of children and youth of Vojvodina

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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).	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
Active Comparator: 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)	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative pain	Postoperative pain level measured using the visual analog scale (VAS)	5 hours
Postoperative pain	Postoperative pain level measured using the Wong-Baker Faces pain rating scale	5 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood pressure	Noninvasive measurement of systolic and diastolic blood pressure	5 hours
Heart rate	Heart rate measured with electrocardiogram	5 hours

Collaborators and Investigators

• Sponsor: University of Novi Sad

Study record dates

Study Major Dates

• Study Start (Actual): January 8, 2022
• Primary Completion (Actual): July 20, 2024
• Study Completion (Actual): July 20, 2024

Study Registration Dates

• First Submitted: July 7, 2023
• First Submitted That Met QC Criteria: July 15, 2023
• First Posted (Actual): July 24, 2023

Study Record Updates

• Last Update Posted (Estimated): December 4, 2024
• Last Update Submitted That Met QC Criteria: December 3, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: pain; general anesthesia; hemodynamic parameters; caudal block
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Postoperative Complications; Pathologic Processes; Pain, Postoperative; Physiological Effects of Drugs; Peripheral Nervous System Agents; Anesthetics, Local; Anesthetics; Central Nervous System Depressants; Sensory System Agents; Levobupivacaine
• Other Study ID Numbers: 05689/25-2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No