Caudal Block for Inguinal Hernioplasty in Children

Study Overview
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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.

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

Conditions
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Postoperative Pain

Intervention / Treatment
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* Drug: Caudal block with levobupivacaine
* Drug: General anesthesia
* Procedure: Inguinal hernioplasty


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 5 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: General anesthesia + caudal block<br>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<br>* 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).<br>Drug: General anesthesia<br>* 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®).<br>Procedure: Inguinal hernioplasty<br>* Elective inguinal hernioplasty<br>|
| Active Comparator: General anesthesia<br>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<br>* 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®).<br>Procedure: Inguinal hernioplasty<br>* Elective inguinal hernioplasty<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pain, general anesthesia, caudal block, hemodynamic parameters