World Hip Trauma Evaluation - LIT: Lidocaine Intravenous Trial
Hip fracture
WHiTE 10-LIT is a randomised comparison appended to the World Hip Trauma Evaluation (WHiTE ) Platform. WHiTE is a platform trials framework, designed to efficiently deliver multiple randomised comparisons of interventions for patients aged 60 years and over with a hip fracture. The platform and its appended randomised comparisons are governed by one single set of ethical and regulatory approvals and an explicit legal basis and processing purpose for the use of patient-level data. The Platform affords a common core dataset and documentation. Individual randomised comparisons are not dependent on each other and each will have its unique start and stop dates and publication of results without compromising the integrity of the platform. Participants will be randomised on a 1:1 basis to lidocaine or placebo infusion, stratified by presence of cognitive impairment at presentation and recruitment centre: 1. Intervention: Intravenous lidocaine 1.5 mg.kg-1 bolus followed by infusion of 1.5 mg.kg-1.h-1 for the duration of surgery 2. Placebo control: Identical volumes of 0.9% saline The allowed maximum absolute dose will be 120 mg and 120 mg h-1 regardless of weight. Randomisation will be on a 1:1 basis to lidocaine or placebo, stratified by the presence/absence of permanent cognitive impairment at presentation and recruitment centre. The allocation sequence will be generated by the trial statistician using variable block sizes and stored securely in a web-based encrypted system provided by the CTU. An appropriately trained individual other than the treating clinician or anyone involved in the assessment of any trial outcomes will carry out the online randomisation and prepare a syringe with the allocated intervention, in an area away from the clinical team. The prepared syringe will then be labelled ‘lidocaine 1% or saline 0.9%’ so as not to reveal the treatment allocation to the treating anaesthetist when they administer it to the participant in order to ensure that t
Platform inclusion criteria: 1. Aged ≥60 years 2. Diagnosed with a hip fracture that in the opinion of the treating surgeon may benefit from surgical treatment No additional specific inclusion criteria for LIT.
Platform exclusion criteria. 1. Previous participation in the same randomised comparison 2. A second hip fracture (other side) while the patient is still enrolled in the Platform following their first hip fracture Additional specific exclusion criteria for LIT: 1. Body weight estimated to be <40 kg or >100 kg 2. Known subdural haematoma 3. Known allergy to local anaesthetics 4. Severely impaired renal (eGFR <30 ml.min-1) or hepatic (based on clinical history) function 5. Patient has specific contraindications to lidocaine: 5.1. All grades of atrioventricular block; severe myocardial depression; sino-atrial disorders 5.2. Acute porphyria 5. 3. Current congestive cardiac failure 6. Concurrent participation in a clinical trial of a medicinal product or recent participation within 5 half-lives of the last dose of medicinal product 7. Local anaesthetic nerve block administered within the previous 6 hours 8. Known serum albumin <30 g/l