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NCT Number: NCT05958589

Caudal Block for Inguinal Hernioplasty in Children

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.

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Key information

Conditions

Postoperative Pain Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

3 year–5 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 3

Primary location

Institute for health care of children and youth of Vojvodina

Novi Sad, Vojvodina, 21000, Serbia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Caudal block with levobupivacaine

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

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

Procedure

Elective inguinal hernioplasty

Primary outcomes

  1. Postoperative pain

    Time frame: 5 hours

    Postoperative pain level measured using the visual analog scale (VAS)

  2. Postoperative pain

    Time frame: 5 hours

    Postoperative pain level measured using the Wong-Baker Faces pain rating scale

Secondary outcomes

  1. Blood pressure

    Time frame: 5 hours

    Noninvasive measurement of systolic and diastolic blood pressure

  2. Heart rate

    Time frame: 5 hours

    Heart rate measured with electrocardiogram

Sponsors and collaborators

Lead sponsor

University of Novi Sad

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Jul 24, 2023
Registry last updated
Dec 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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