A trial to develop a population pharmacokinetics model for the administration of intravenous lidocaine to adult female patients undergoing breast reconstructive surgery

Royal Perth Hospital0 个研究点目标入组 40 人开始时间: 2023年3月6日最近更新: 2023年5月29日

适应症

试验速览

暂无简介。

•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

•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
•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)

发起方