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Completed

NCT Number: NCT06909396

Stress Response and Hemodynamic Changes Associated With Intrathecal Anesthesia Versus Caudal Epidural Anesthesia in Infants Undergoing Laparoscopic Inguinal Herniorrhaphy

The aim of this work was to assess stress response and hemodynamic changes associated with intrathecal anesthesia versus caudal epidural anesthesia in infants undergoing laparoscopic inguinal herniorrhaphy.

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Key information

Age range

1 month–1 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tanta University

Tanta, El-Gharbia, 31527, Egypt

About this study

Inguinal hernia repair is the most frequent surgical procedure in early childhood. Various regional anesthetic techniques have been employed to provide optimum intraoperative and postoperative pain control after this procedure.

Introduced decades ago, the use of intrathecal (spinal) anesthesia and caudal block in procedures for different types of laparoscopic abdominal surgery is safe and efficient.

Caudal block is now frequently used in intraoperative and postoperative analgesia for pediatric surgery. In infants and children, central neuraxial block is an important modality for acute postoperative analgesia in addition to combined anesthesia, the goals of postoperative analgesia in children are pain eradication, expedient recovery to daily activities, and prevention of progression of acute postsurgical pain to chronic pain or hyperalgesia

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age from full term one month to one year.
  • Both sexes.
  • Patients with clinical criteria of laparoscopic inguinal herniorrhaphy.

Exclusion criteria

  • Refusal of patients' parents.
  • Diseases of the central nervous system.
  • Patients with metabolic and coagulation defects.
  • Pre-term infant.
  • Infection at the site of injection.
  • Congenital anomaly in vertebral column.
  • Patient treated with corticosteroids.
  • Patients with respiratory dysfunction.

Treatment and study plan

General anesthesia

Drug

Patients received general anesthesia

Intrathecal anesthesia

Drug

Patients received intrathecal Anesthesia

Caudal block

Drug

Patients received caudal epidural anesthesia.

Primary outcomes

  1. Serum glucose level

    Time frame: 24 hours postoperatively

    Serum glucose level was recorded pre-operative and just postoperative and 6, 12, and 24h postoperatively.

Secondary outcomes

  1. Serum cortisol level

    Time frame: 24 hours postoperatively

    Serum cortisol level was recorded pre-operative and just postoperative and 6, 12, and 24h postoperatively.

  2. Heart rate

    Time frame: Till the end of surgery (Up to 1 hour)

    Heart rate was recorded at baseline, after induction, then every 15 minutes till the end of surgery.

  3. Mean arterial pressure

    Time frame: Till the end of surgery (Up to 1 hour)

    Mean arterial pressure was recorded at baseline, after induction, then every 15 minutes till the end of surgery.

  4. Intraoperative anesthetic consumption

    Time frame: Intraoperatively

    Intraoperative anesthetic consumption of sevoflurane was recorded.

  5. Total analgesics consumption

    Time frame: 24 hours postoperatively

    Intravenous Tramadol 1 mg/kg is administered intravenously in the event that the Face, Legs, Activity, Cry, Consolability (FLACC) score exceeds 4 within the first 24 hours following surgery.

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Official study title

Stress Response and Hemodynamic Changes Associated With Intrathecal Anesthesia Versus Caudal Epidural Anesthesia in Infants Undergoing Laparoscopic Inguinal Herniorrhaphy: Prospective Randomized Control Study

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Apr 3, 2025
Registry last updated
Apr 3, 2025

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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