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

Not Applicable

Completed

• Conditions: Stress Response; Hemodynamic Changes; Intrathecal Anesthesia; Caudal Epidural Anesthesia; Infants; Laparoscopic Inguinal Herniorrhaphy
• Interventions: Drug: General anesthesia; Drug: Intrathecal Anesthesia; Drug: Caudal block

• Registration Number: NCT06909396
• Lead Sponsor: Tanta University

Brief Summary

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.

Detailed Description

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

Study Timeline

• Study Start: 2023-06-01
• Primary Completion: 2025-01-20
• Study Completion: 2025-01-20
• Status Verified: 2025-03
• Study First Submitted: 2025-03-27
• Study First Submitted QC: 2025-03-27
• Last Update Submitted: 2025-03-27
• Study First Posted: 2025-04-03
• Last Update Posted: 2025-04-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	General anesthesia	Patients received general anesthesia.
Intrathecal group	Intrathecal Anesthesia	Patients received intrathecal anesthesia.
Caudal block group	Caudal block	Patients received caudal epidural anesthesia.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Serum cortisol level	24 hours postoperatively	Serum cortisol level was recorded pre-operative and just postoperative and 6, 12, and 24h postoperatively.
Heart rate	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.
Mean arterial pressure	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.
Intraoperative anesthetic consumption	Intraoperatively	Intraoperative anesthetic consumption of sevoflurane was recorded.
Total analgesics consumption	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.

Trial Locations

Locations (1)

Tanta University; 🇪🇬 Tanta, El-Gharbia, Egypt