Pharmacokinetic Profile of Lidocaine Given as a Weight-based Infusion for Postoperative Surgical Pain Control

NCT05402293 | Terminated

• 1 other identifier: Pro00089761
• Study Type: observational
• Target: 7
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Lidocaine; Administration and Dosage; Acute Pain

Keywords

Acute Pain; Lidocaine Infusion; Pharmakokinetics; Post-operative analgesia

Outcome Measures

Primary Outcomes (1)

• Lidocaine concentrations from plasma samples

  The study will measure lidocaine concentrations in this surgical population receiving lidocaine infusion for post-operative analgesia

  48 hours from initiation of lidocaine infusion

Interventions

Blood samples to measure lidocaine levels DIAGNOSTIC_TEST

Blood sampling is the only intervention Plasma samples will then be analyzed for lidocaine concentration

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing major elective surgery at the University of Alberta Hospital. Edmonton who are receiving lidocaine infusion as part of their post-operative pain management

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Alberta: lead

Study Sites (1)

University of Alberta

Edmonton, Alberta, T6G2R3, Canada

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma samples for analysis of lidocaine concentration Will be disposed of following analysis

MeSH Terms

Conditions

Acute Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• James Green, MB BS

  University of Alberta

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Days
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 29, 2022
• First Posted: June 2, 2022
• Study Start: February 12, 2025
• Primary Completion: March 12, 2025
• Study Completion: March 12, 2025
• Last Updated: February 9, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)