Pharmacokinetic Profile of Lidocaine Given as a Weight-based Infusion for Postoperative Surgical … (NCT05402293) | Clinical Trial Compass
TerminatedNot Applicable
Pharmacokinetic Profile of Lidocaine Given as a Weight-based Infusion for Postoperative Surgical Pain Control
Stopped: Enrollment difficulties
Canada7 participantsStarted 2025-02-12
Plain-language summary
Study Summary
Title Pharmacokinetic profile of lidocaine given as a weight-based infusion for postoperative surgical pain control
Short Title Pharmacokinetic profile of lidocaine given as a weight-based infusion for postoperative surgical pain control
Methodology Pharmacokinetic study of lidocaine in the surgical population
Study Duration 1 year
Study Center(s) University of Alberta Hospital
Objectives The primary objective will be to map serum lidocaine levels over time in a diverse surgical patient population receiving a weight-based lidocaine infusion.
Number of Subjects 40
Diagnosis and Main Inclusion Criteria ASA class 1-3 Age 18-40 or \>75 Scheduled for elective major ENT flap, urology or general surgery.
Study Product, Dose, Route, Regimen Lidocaine IV infusion
* 1.5mg/kg bolus, then
* 1mg/kg/h IV intraoperatively, then
* 0.5-2 mg/kg/hr IV for 48 h, depending on clinical response
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* ASA class 1-3. Age 18-40 or \>75. - Scheduled for elective major surgery at the University of Alberta Hospital in which lidocaine infusion would be a good option as part of standard multimodal analgesia care
Exclusion Criteria:
* Contraindication / History of hypersensitivity to lidocaine or amide local anesthetics
* Inability to give informed consent (illiteracy, \<7th grade education)
* NYHA class III-IV heart disease
* Planned epidural or regional anesthesia technique requiring local anesthetic
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Lidocaine concentrations from plasma samples
Timeframe: 48 hours from initiation of lidocaine infusion