ACTRN12623000240640
Not yet recruiting
Phase 4
A trial to develop a population pharmacokinetics model for the administration of intravenous lidocaine to adult female patients undergoing breast reconstructive surgery
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Pain Management
- Sponsor
- Royal Perth Hospital
- Enrollment
- 40
- Status
- Not yet recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
- •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
Outcomes
Primary Outcomes
Not specified
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