Caudal Block for Inguinal Hernioplasty in Children

Postoperative Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05958589
• Other study ID #: 05689/25-2
• Status: Recruiting
• Phase: Phase 3
• Start date: January 8, 2022
• Est. completion date: December 2025

Study information

• Verified date: July 2023
• Source: University of Novi Sad
• Contact: Marina Pandurov, MD, PhD
• Phone: +381641914714
• Email: marina.pandurov[@]mf.uns.ac.rs
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: December 2025
• Est. primary completion date: January 2025
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 3 Years to 5 Years

Eligibility

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

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

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).
• 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

Locations

Country	Name	City	State
Serbia	Institute for health care of children and youth of Vojvodina	Novi Sad	Vojvodina

Sponsors (1)

Lead Sponsor	Collaborator
University of Novi Sad

Country where clinical trial is conducted

Serbia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative pain	Postoperative pain level measured using the visual analog scale (VAS)	5 hours
Primary	Postoperative pain	Postoperative pain level measured using the Wong-Baker Faces pain rating scale	5 hours
Secondary	Blood pressure	Noninvasive measurement of systolic and diastolic blood pressure	5 hours
Secondary	Heart rate	Heart rate measured with electrocardiogram	5 hours