idocaine Infusion Population Pharmacokinetics Study (LIPPS): determining pharmacokinetics of lidocaine in those undergoing breast reconstructive surgery

Phase 4

• Conditions: Pain Management; Anaesthesiology - Pain management; Anaesthesiology - Anaesthetics

• Registration Number: ACTRN12623000240640
• Lead Sponsor: Royal Perth Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-03-06
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: Female
• Target Recruitment: 40

Inclusion Criteria

•Adult biological female patient aged >=18 and <80 years old
•Undergoing remote breast reconstructive surgery with a unilateral or bilateral DIEP (or other myocutaneous) flap
•ASA physical status 1-3

Exclusion Criteria

•Inability to provide informed consent – impaired cognition. Where consent cannot be obtained in English, an interpreter should be used to obtain informed consent
•Pregnancy
•History of epilepsy
•History of anaphylaxis, sensitivity or known contraindication to lidocaine or other amide local anaesthetics, including patients with porphyria and methaemaglobinaemia
•Baseline HR <50bpm or SBP <100mmHg
•Acute coronary event within the last 3 months
•Cardiac Conduction abnormalities including: Heart block (all degrees), Bundle Branch Block or Fascicular Block, Prolonged QT interval, Wolf Parkinson White Syndrome, channellopathy (e.g. Brugada Syndrome). A preoperative ECG is not mandatory.
•Abnormal serum sodium and/or potassium concentrations
•Active liver disease or abnormal liver function tests
•Medications within the last 7 days which affect lidocaine metabolism (amiodarone, beta blockers, cimetidine, fluoroquinolones, fluvoxamine, imidazoles, macrolides, verapamil, HIV drugs
•Cardiac Failure
•Severe renal disease (CrCl <30ml/min or dialysis dependent)
•Recruitment into LOLIPOP or any other Trial
•Planned regional anaesthesia/analgesia technique
•Co-administration of lidocaine within 24 hours of surgery (e.g. lidocaine patch)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To establish the pharmacokinetics of lidocaine administered by intravenous infusion, as assessed by serial blood sample concentration determination. Parameters assessed will include the central and peripheral volume of distribution (VD), interdepartmental clearances, hourly clearance and elimination half-life (t½elim) of lidocaine when administered by intravenous infusion [Serial serum lidocaine samples will be taken in study participants at specified time intervals to plot serum concentrations according to dosage and time. Samples will be taken hourly for the duration of the infusion, once postoperative in PACU and twice more (to examine elimination pharmacokinetics) between 8 and 26 hours post cessation of the infusion]