World Hip Trauma Evaluation - LIT: an investigation in people 60 years and over with a hip fracture to determine whether an infusion of a local anaesthetic (lidocaine) can reduce symptoms of delirium in the first five days after hip fracture surgery
- Conditions
- Hip fractureMusculoskeletal DiseasesFracture of neck of femur
- Registration Number
- ISRCTN10817487
- Lead Sponsor
- niversity of Oxford
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing
- Sex
- All
- Target Recruitment
- 416
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Peak post-operative delirium as measured by the Memorial Delirium Assessment Scale (MDAS) at days 1-5 after surgery.
- Secondary Outcome Measures
Name Time Method