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

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

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.

Study Overview

• Status: Completed
• Conditions: Stress Response; Hemodynamic Changes; Infants; Intrathecal Anesthesia; Caudal Epidural Anesthesia; Laparoscopic Inguinal Herniorrhaphy
• Intervention / Treatment: Drug: General anesthesia; Drug: Intrathecal Anesthesia; Drug: Caudal block

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 Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • El-Gharbia
    • Tanta, El-Gharbia, Egypt, 31527
      • Tanta University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control group; Patients received general anesthesia.	Drug: General anesthesia; Patients received general anesthesia
Experimental: Intrathecal group; Patients received intrathecal anesthesia.	Drug: Intrathecal Anesthesia; Patients received intrathecal Anesthesia
Experimental: Caudal block group; Patients received caudal epidural anesthesia.	Drug: Caudal block; Patients received caudal epidural anesthesia.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Serum glucose level	Serum glucose level was recorded pre-operative and just postoperative and 6, 12, and 24h postoperatively.	24 hours postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Serum cortisol level	Serum cortisol level was recorded pre-operative and just postoperative and 6, 12, and 24h postoperatively.	24 hours postoperatively
Heart rate	Heart rate was recorded at baseline, after induction, then every 15 minutes till the end of surgery.	Till the end of surgery (Up to 1 hour)
Mean arterial pressure	Mean arterial pressure was recorded at baseline, after induction, then every 15 minutes till the end of surgery.	Till the end of surgery (Up to 1 hour)
Intraoperative anesthetic consumption	Intraoperative anesthetic consumption of sevoflurane was recorded.	Intraoperatively
Total analgesics consumption	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.	24 hours postoperatively

Collaborators and Investigators

• Sponsor: Tanta University

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2023
• Primary Completion (Actual): January 20, 2025
• Study Completion (Actual): January 20, 2025

Study Registration Dates

• First Submitted: March 27, 2025
• First Submitted That Met QC Criteria: March 27, 2025
• First Posted (Actual): April 3, 2025

Study Record Updates

• Last Update Posted (Actual): April 3, 2025
• Last Update Submitted That Met QC Criteria: March 27, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Hernia; Hernia, Abdominal; Hernia, Inguinal; Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics
• Other Study ID Numbers: 35680/8/22

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
• IPD Sharing Time Frame: After the end of study for one year.
• IPD Sharing Access Criteria: The data will be available upon a reasonable request from the corresponding author.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No