Caudal Block for Inguinal Hernioplasty in Children

Sponsor

University of Novi Sad (Other)

Overall Status

Recruiting

CT.gov ID

NCT05958589

Collaborator

(none)

Enrollment

Location

Arms

46.8

Anticipated Duration (Months)

1.5

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Postoperative Pain	Drug: Caudal block with levobupivacaine Drug: General anesthesia Procedure: Inguinal hernioplasty	Phase 3

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 Design

Study Type:

Interventional

Anticipated Enrollment :

70 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jan 8, 2022

Anticipated Primary Completion Date :

Jan 1, 2025

Anticipated Study Completion Date :

Dec 1, 2025

Arms and Interventions

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

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

Procedure: Inguinal hernioplasty

Elective inguinal hernioplasty

Outcome Measures

Primary Outcome Measures

Postoperative pain [5 hours]
Postoperative pain level measured using the visual analog scale (VAS)
Postoperative pain [5 hours]
Postoperative pain level measured using the Wong-Baker Faces pain rating scale

Secondary Outcome Measures

Blood pressure [5 hours]
Noninvasive measurement of systolic and diastolic blood pressure
Heart rate [5 hours]
Heart rate measured with electrocardiogram

Eligibility Criteria

Criteria

Ages Eligible for Study:

3 Years to 5 Years

Sexes Eligible for Study:

Male

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Institute for health care of children and youth of Vojvodina	Novi Sad	Vojvodina	Serbia	21000

Sponsors and Collaborators

University of Novi Sad

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Mihaela Preveden, Research Assistant, University of Novi Sad

ClinicalTrials.gov Identifier:

NCT05958589

Other Study ID Numbers:

05689/25-2

First Posted:

Jul 24, 2023

Last Update Posted:

Jul 24, 2023

Last Verified:

Jul 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Mihaela Preveden, Research Assistant, University of Novi Sad

general anesthesia

caudal block

pain

hemodynamic parameters

Additional relevant MeSH terms:

Pain, Postoperative

Levobupivacaine

Study Results

No Results Posted as of Jul 24, 2023