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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06909396
Enrollment
120
Registered
2025-04-03
Start date
2023-06-01
Completion date
2025-01-20
Last updated
2025-04-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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

Interventions

DRUGGeneral anesthesia

Patients received general anesthesia

Patients received intrathecal Anesthesia

DRUGCaudal block

Patients received caudal epidural anesthesia.

Sponsors

Tanta University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
1 Months to 1 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Serum glucose level24 hours postoperativelySerum glucose level was recorded pre-operative and just postoperative and 6, 12, and 24h postoperatively.

Secondary

MeasureTime frameDescription
Serum cortisol level24 hours postoperativelySerum cortisol level was recorded pre-operative and just postoperative and 6, 12, and 24h postoperatively.
Heart rateTill 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 pressureTill 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 consumptionIntraoperativelyIntraoperative anesthetic consumption of sevoflurane was recorded.
Total analgesics consumption24 hours postoperativelyIntravenous 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.

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026