The Effect of Intraoperative Intravenous Lidocaine Infusion on Postoperative Pain and Recovery in Children (< 7 Years Old) Undergoing Thoracoscopic Surgery

Phase 4

Recruiting

• Conditions: Pain Management After Surgery
• Interventions: Drug: Lidocaine (drug); Drug: Saline infusion (placebo)

• Registration Number: NCT06710405
• Lead Sponsor: Seoul National University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-11-25
• Study First Submitted QC: 2024-11-25
• Study First Posted: 2024-11-29
• Study Start: 2024-12-09
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-11
• Last Update Posted: 2025-05-14
• Primary Completion: 2026-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lidocaine group	Lidocaine (drug)	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.
Control group	Saline infusion (placebo)	The control group receives a continuous infusion of normal saline in the same volume as that administered to the lidocaine group.

Primary Outcome Measures

Name	Time	Method
FLACC (ace, Legs, Activity, Cry, Consolability scale) Score	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 Outcome Measures

Name	Time	Method
Remifentanil dose	throughout surgery (up to 3 hours)	Total amount of remifentanil administered during surgery
ANI (Analgesia Nociception Index)	throughout surgery (up to 3 hours)	ANI (Analgesia Nociception Index) values during surgery (scale ranging from 0 (indicating maximum pain) to 100 (indicating no pain))
FLACC scores	6 hours, 12 hours, and 24 hours postoperatively	FLACC scores at 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)

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of