Caudal Block for Inguinal Hernioplasty in Children

University of Novi Sad

Status and phase: Completed; Phase 3

Conditions: Postoperative Pain

Treatments: Drug: Caudal block with levobupivacaine; Drug: General anesthesia; Procedure: Inguinal hernioplasty

Study type: Interventional

Funder types: Other

Identifiers

NCT05958589

05689/25-2

Details and patient eligibility

About

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.

Full 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.

Enrollment: 70 patients

Sex: Male

Ages: 3 to 5 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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70 participants in 2 patient groups

General anesthesia + caudal block

Experimental group

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).

Treatment:

Procedure: Inguinal hernioplasty

Drug: General anesthesia

Drug: Caudal block with levobupivacaine

General anesthesia

Active Comparator group

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)

Treatment:

Procedure: Inguinal hernioplasty

Drug: General anesthesia