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Caudal Block for Inguinal Hernioplasty in Children

NCT ID: NCT05958589

Last Updated: 2024-12-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-08

Study Completion Date

2024-07-20

Brief Summary

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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

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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.

Conditions

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Postoperative Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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).

Group Type EXPERIMENTAL

Caudal block with levobupivacaine

Intervention Type DRUG

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

Intervention Type DRUG

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®).

Inguinal hernioplasty

Intervention Type PROCEDURE

Elective 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)

Group Type ACTIVE_COMPARATOR

General anesthesia

Intervention Type DRUG

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®).

Inguinal hernioplasty

Intervention Type PROCEDURE

Elective inguinal hernioplasty

Interventions

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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).

Intervention Type 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®).

Intervention Type DRUG

Inguinal hernioplasty

Elective inguinal hernioplasty

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

3 Years

Maximum Eligible Age

5 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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University of Novi Sad

OTHER

Sponsor Role lead

Responsible Party

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Mihaela Preveden

Research Assistant

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Institute for health care of children and youth of Vojvodina

Novi Sad, Vojvodina, Serbia

Site Status

Countries

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Serbia

Other Identifiers

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05689/25-2

Identifier Type: -

Identifier Source: org_study_id