Abstract
OBJECTIVES: To compare costs, health outcomes and cost-effectiveness of using intravenous lidocaine (bolus given at induction of anaesthesia, followed by infusion for 6-12 hours) during colorectal surgery to improve the return of gastrointestinal function. DESIGN: Within-trial planned analysis of data from a randomised controlled trial using an intention-to-treat approach. SETTING: 27 hospitals from across the UK. PARTICIPANTS: 557 patients aged 25-91 having minimally invasive elective colorectal resection. INTERVENTION: A 1:1 randomisation between intravenous lidocaine and placebo, minimised for age (<50 years, 50-74 years, ≥75 years), gender, and trial centre. PRIMARY OUTCOME MEASURES: Mean differences between trial arms in 30-day and 90-day quality-adjusted life-years (QALYs) and 30-day total National Health Service costs, as well as the 30-day incremental cost-effectiveness ratio. RESULTS: Compliance and data quality were high. Intravenous lidocaine is associated with differences of £38 (95% CI: -£463, £589) in total 30-day costs, -0.0005 (95% CI: -0.0027, 0.0015) in 30-day QALYs and -0.0008 (95% CI: -0.0066, 0.0048) in 90-day QALYs. No large, statistically significant or meaningful differences in primary or secondary outcome measures between trial arms were detected, other than for the intervention costs. CONCLUSION: Intravenous lidocaine is not found to impact costs or health outcomes for patients undergoing colorectal surgery. In the absence of a clinical effect, disinvestment from perioperative lidocaine could save costs associated with infusion monitoring. TRIAL REGISTRATION NUMBER: International Standard Randomised Controlled Trial Number 52352431.