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Caudal Block for Inguinal Hernioplasty in Children

Primary Purpose

Postoperative Pain

Status
Recruiting
Phase
Phase 3
Locations
Serbia
Study Type
Interventional
Intervention
Caudal block with levobupivacaine
General anesthesia
Inguinal hernioplasty
Sponsored by
University of Novi Sad
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Pain focused on measuring general anesthesia, caudal block, pain, hemodynamic parameters

Eligibility Criteria

3 Years - 5 Years (Child)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Institute for health care of children and youth of VojvodinaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

General anesthesia + caudal block

General anesthesia

Arm Description

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).

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)

Outcomes

Primary Outcome Measures

Postoperative pain
Postoperative pain level measured using the visual analog scale (VAS)
Postoperative pain
Postoperative pain level measured using the Wong-Baker Faces pain rating scale

Secondary Outcome Measures

Blood pressure
Noninvasive measurement of systolic and diastolic blood pressure
Heart rate
Heart rate measured with electrocardiogram

Full Information

First Posted
July 7, 2023
Last Updated
July 15, 2023
Sponsor
University of Novi Sad
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1. Study Identification

Unique Protocol Identification Number
NCT05958589
Brief Title
Caudal Block for Inguinal Hernioplasty in Children
Official Title
Efficacy and Safety of General Anesthesia With Caudal Block for Inguinal Hernioplasty in Children: a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 8, 2022 (Actual)
Primary Completion Date
January 2025 (Anticipated)
Study Completion Date
December 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Novi Sad

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain
Keywords
general anesthesia, caudal block, pain, hemodynamic parameters

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
General anesthesia + caudal block
Arm Type
Experimental
Arm Description
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).
Arm Title
General anesthesia
Arm Type
Active Comparator
Arm Description
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 Type
Drug
Intervention Name(s)
Caudal block with levobupivacaine
Intervention Description
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).
Intervention Type
Drug
Intervention Name(s)
General anesthesia
Intervention Description
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®).
Intervention Type
Procedure
Intervention Name(s)
Inguinal hernioplasty
Intervention Description
Elective inguinal hernioplasty
Primary Outcome Measure Information:
Title
Postoperative pain
Description
Postoperative pain level measured using the visual analog scale (VAS)
Time Frame
5 hours
Title
Postoperative pain
Description
Postoperative pain level measured using the Wong-Baker Faces pain rating scale
Time Frame
5 hours
Secondary Outcome Measure Information:
Title
Blood pressure
Description
Noninvasive measurement of systolic and diastolic blood pressure
Time Frame
5 hours
Title
Heart rate
Description
Heart rate measured with electrocardiogram
Time Frame
5 hours

10. Eligibility

Sex
Male
Gender Based
Yes
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marina Pandurov, MD, PhD
Phone
+381641914714
Email
marina.pandurov@mf.uns.ac.rs
Facility Information:
Facility Name
Institute for health care of children and youth of Vojvodina
City
Novi Sad
State/Province
Vojvodina
ZIP/Postal Code
21000
Country
Serbia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marina Pandurov, MD, PhD
Phone
+381641914714
Email
marina.pandurov@mf.uns.ac.rs

12. IPD Sharing Statement

Plan to Share IPD
No

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Caudal Block for Inguinal Hernioplasty in Children

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