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

NCT ID: NCT06710405

Last Updated: 2025-05-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-09

Study Completion Date

2026-12-31

Brief Summary

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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

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Conditions

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Pain Management After Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Lidocaine (drug)

Intervention Type 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.

Control group

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

Group Type PLACEBO_COMPARATOR

Saline infusion (placebo)

Intervention Type DRUG

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

Interventions

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Lidocaine (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.

Intervention Type DRUG

Saline infusion (placebo)

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

6 Months

Maximum Eligible Age

7 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Ji-Hyun Lee

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Seoul National University Hospital

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Ji-Hyun Lee, MD, PhD

Role: CONTACT

82-2-2072-3661

Facility Contacts

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Ji-Hyun Lee, MD, PhD

Role: primary

+82-10-7665-8848

Other Identifiers

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H2409-100-1573

Identifier Type: -

Identifier Source: org_study_id

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