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NCT Number: NCT06710405

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

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.

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Key information

Conditions

Pain Management After Surgery Agnosia Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms

Age range

6 month–7 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Seoul National University Hospital

Seoul, 03080, South Korea

Location status: Recruiting

Location contact

Ji-Hyun Lee, MD, PhD

CONTACT

[email protected]

+82-10-7665-8848

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Saline infusion (placebo)

Drug

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

Primary outcomes

  1. 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

  1. Remifentanil dose

    Time frame: throughout surgery (up to 3 hours)

    Total amount of remifentanil administered during surgery

  2. ANI (Analgesia Nociception Index)

    Time frame: 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))

  3. FLACC scores

    Time frame: 6 hours, 12 hours, and 24 hours postoperatively

    FLACC scores at 6 hours, 12 hours, and 24 hours postoperatively

  4. Total analgesic dosage administered postoperatively

    Time frame: up to 3 days after surgery

  5. Postoperative complications

    Time frame: until discharge (up to 3-4 days after surgery)

Study contacts

Contact information is provided by the study sponsor or research team.

Ji-Hyun Lee, MD, PhD

CONTACT

[email protected]

82-2-2072-3661

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Nov 29, 2024
Registry last updated
May 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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