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Clinical Trials/NCT06710405
NCT06710405
Recruiting
Phase 4

The Effect of Intraoperative Intravenous Lidocaine Infusion on Postoperative Pain and Recovery in Children (< 7 Years Old) Undergoing Thoracoscopic Surgery:Prospective, Randomized Controlled Trial

Seoul National University Hospital1 site in 1 country80 target enrollmentDecember 9, 2024

Overview

Phase
Phase 4
Intervention
Lidocaine (drug)
Conditions
Pain Management After Surgery
Sponsor
Seoul National University Hospital
Enrollment
80
Locations
1
Primary Endpoint
FLACC (ace, Legs, Activity, Cry, Consolability scale) Score
Status
Recruiting
Last Updated
11 months ago

Overview

Brief Summary

This study aims to investigate the efficacy of intraoperative intravenous lidocaine infusion on postoperative pain management and recovery in pediatric patients undergoing thoracoscopic pulmonary resection.

Registry
clinicaltrials.gov
Start Date
December 9, 2024
End Date
December 31, 2026
Last Updated
11 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Ji-Hyun Lee

Associate Professor

Seoul National University Hospital

Eligibility Criteria

Inclusion Criteria

  • Pediatric patients aged under 7 years undergoing thoracoscopic pulmonary resection

Exclusion Criteria

  • cardiac dysfunction requiring vasopressors or inotropic agents
  • atrioventricular block or bradycardia
  • Liver or kidney dysfunction
  • Hypersensitivity to local anesthetics

Arms & Interventions

Lidocaine group

Anesthesia induction is performed according to the standard protocol. Monitoring includes electrocardiography, pulse oximetry, arterial blood pressure, depth of anesthesia (Patient State Index, PSI), and pain score (Analgesia Nociception Index). In the lidocaine group, a single bolus dose of lidocaine 1.5 mg/kg is administered concurrently with the induction of anesthesia, followed by a continuous infusion of lidocaine at a rate of 1.5 mg/kg/hr.

Intervention: Lidocaine (drug)

Control group

The control group receives a continuous infusion of normal saline in the same volume as that administered to the lidocaine group.

Intervention: Saline infusion (placebo)

Outcomes

Primary Outcomes

FLACC (ace, Legs, Activity, Cry, Consolability scale) Score

Time Frame: up to 1 hour after surgery

Highest FLACC Score recorded in the postanesthesia care unit (The scale is scored in a range of 0-10 with 0 representing no pain.)

Secondary Outcomes

  • Remifentanil dose(throughout surgery (up to 3 hours))
  • ANI (Analgesia Nociception Index)(throughout surgery (up to 3 hours))
  • FLACC scores(6 hours, 12 hours, and 24 hours postoperatively)
  • Total analgesic dosage administered postoperatively(up to 3 days after surgery)
  • Postoperative complications(until discharge (up to 3-4 days after surgery))

Study Sites (1)

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