None listed
Conditions
Brief summary
The purpose of this study is to determine whether a study to look at the safety and efficacy of an infusion of lidocaine at the time of breast surgery is feasible. Who is it for? You may be eligible for this study if you are over the age of 18 and are undergoing breast cancer surgery. Study details Participants will be randomised to one of two groups. One group will be given a lidocaine infusion during and for 12 hours after breast cancer surgery, and the other group will be given a placebo infusion. Participants will then undergo a number of tests including lidocaine levels in the blood at two different time points after your surgery and inflammatory proteins to see if these are altered by the infusion. They will also be followed up by researchers for 6 months following the breast cancer surgery. It is hoped that this research will help expand research in long-term pain relief for those undergoing breast cancer surgeries.
Interventions
At the time of induction, prior to surgical incision, a bolus of 1.5mg/kg of Lidocaine will be delivered intravenously followed by 2mg/kg/hr for the duration of surgery by the treating anaesthetist. This will be under research coordinator supervision with appropriate dosing checked by both the clinical and the research team. At the end of the case the total dose will be recorded along with the duration of the case. In the post anaesthesia care unit, a subcutaneous infusion of 1.33mg/kg/hr will b
At the time of induction, prior to surgical incision, a bolus of 1.5mg/kg of Lidocaine will be delivered intravenously followed by 2mg/kg/hr for the duration of surgery by the treating anaesthetist. This will be under research coordinator supervision with appropriate dosing checked by both the clinical and the research team. At the end of the case the total dose will be recorded along with the duration of the case. In the post anaesthesia care unit, a subcutaneous infusion of 1.33mg/kg/hr will be commenced for a duration of 12 hours. There will be four hourly saftety checks by ward staff and a research coordinator review on the ward. The research staff will be available 24/7 in the event of uncertainties.
Sponsors
Royal Perth Hospital
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
Adult females whom have a American Society of Anesthesiologists physical scale of 1 to 3 and are undergoing breast cancer surgery excluding hookwire guided excisions.
Exclusion criteria
Use of flap from distant site (e.g. DIEP, TRAM, Latissmus Dorsi); Surgery which is being repeated or where the margins have been deemed insufficient; Breast Reduction Surgery; When further surgery within 30 days is planned or likely; Known Metastatic Disease; Pregnant and Lactating Women; Non-English speaking or other obvious difficulty with communication; No access to telephone; Cognitive deficit or obvious cognitive decline; Severe Renal Failure (Creatinine Clearance of less than 30ml/min or dialysis dependent); Hepatic derangement or documented liver disease; Heart failure; Epilepsy; sensitivity to Lidocaine or other amide local anaesthetic; Unstable Ischaemic heart disease; Atrial Fibrillation; Heart block (all degrees); Complete Bundle Branch Block, Fasicular block; Prolonged QT interval; Wolf Parkinson White syndrome; Syncope; Baseline hypotension (Systolic BP < 90mmHg); Antipsychotic medications; Antiretroviral therapies; Potent 1A2 inhibitors (Ciprofloxacin or Norfloxacin); 3A4 inhibitors (Itraconazole or Ketoconazole); Abnormal Serum Potassium (<3.5 or >5mmol/L); Baseline resting oxygen saturations below 94%.
Outcome results
None listed