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

NCT06710405 | Recruiting Phase 4 DMC

• 1 other identifier: H2409-100-1573
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain Management After Surgery

Keywords

pediatric; thoracoscopic surgery; pain control; lidocaine

Outcome Measures

Primary Outcomes (1)

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

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

  up to 1 hour after surgery

Secondary Outcomes (5)

• 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 Arms (2)

Lidocaine group

EXPERIMENTAL

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.

Drug: Lidocaine (drug)

Control group

PLACEBO COMPARATOR

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

Drug: Saline infusion (placebo)

Interventions

Lidocaine (drug) DRUG

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.

Lidocaine group

Saline infusion (placebo) DRUG

Continuous infusion of normal saline in the same volume as that administered to the lidocaine group.

Control group

Eligibility Criteria

• Age: 6 Months - 7 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Pediatric patients aged under 7 years undergoing thoracoscopic pulmonary resection

You may not qualify if:

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

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Hospital

Seoul, 03080, South Korea

RECRUITING

MeSH Terms

Conditions

Agnosia

Interventions

Lidocaine; Pharmaceutical Preparations

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Central Study Contacts

Ji-Hyun Lee, MD, PhD

CONTACT

82-2-2072-3661; muslab6@snu.ac.kr

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: November 25, 2024
• First Posted: November 29, 2024
• Study Start: December 9, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: May 14, 2025

Record last verified: 2025-05

Locations

KR (1)