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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-01

Study Completion Date

2025-01-20

Brief Summary

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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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Detailed Description

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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

Conditions

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Stress Response Hemodynamic Changes Intrathecal Anesthesia Caudal Epidural Anesthesia Infants Laparoscopic Inguinal Herniorrhaphy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Control group

Patients received general anesthesia.

Group Type ACTIVE_COMPARATOR

General anesthesia

Intervention Type DRUG

Patients received general anesthesia

Intrathecal group

Patients received intrathecal anesthesia.

Group Type EXPERIMENTAL

Intrathecal Anesthesia

Intervention Type DRUG

Patients received intrathecal Anesthesia

Caudal block group

Patients received caudal epidural anesthesia.

Group Type EXPERIMENTAL

Caudal block

Intervention Type DRUG

Patients received caudal epidural anesthesia.

Interventions

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General anesthesia

Patients received general anesthesia

Intervention Type DRUG

Intrathecal Anesthesia

Patients received intrathecal Anesthesia

Intervention Type DRUG

Caudal block

Patients received caudal epidural anesthesia.

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

1 Month

Maximum Eligible Age

1 Year

Eligible Sex

ALL

Accepts Healthy Volunteers

No