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

ConditionPain Management After Surgery
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age6-7
SponsorSeoul National University Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Pediatric patients aged under 7 years undergoing thoracoscopic pulmonary resection

Disqualifiers

cardiac dysfunction requiring vasopressors or inotropic agents

atrioventricular block or bradycardia

Liver or kidney dysfunction

Hypersensitivity to local anesthetics

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: Lidocaine groupExperimental treatment 1 intervention
Group B: Control groupPlacebo comparator 1 intervention

Trial outcomes

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.)

Time frame
up to 1 hour after surgery

Secondary outcomes

1

Remifentanil dose

Total amount of remifentanil administered during surgery

Time frame
throughout surgery (up to 3 hours)
2

ANI (Analgesia Nociception Index)

ANI (Analgesia Nociception Index) values during surgery (scale ranging from 0 (indicating maximum pain) to 100 (indicating no pain))

Time frame
throughout surgery (up to 3 hours)
3

FLACC scores

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

Time frame
6 hours, 12 hours, and 24 hours postoperatively
4

Total analgesic dosage administered postoperatively

Time frame
up to 3 days after surgery

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Seoul National University Hospital

Lead sponsor

Source ClinicalTrials.gov
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