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Intravenous lidocaine for gut function recovery in colonic surgery: a health economic evaluation of the ALLEGRO randomised clinical trial

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.
Publication status:
Published
Peer review status:
Peer reviewed

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Publisher copy:
10.1136/bmjopen-2024-088298

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Role:
Author
ORCID:
0000-0002-1628-7427
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Role:
Author
ORCID:
0000-0001-8512-4368


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Funder identifier:
https://ror.org/0187kwz08


Publisher:
BMJ Publishing Group
Journal:
BMJ Open More from this journal
Volume:
15
Issue:
2
Article number:
bmjopen-2024-088298
Publication date:
2025-02-25
Acceptance date:
2025-01-23
DOI:
EISSN:
2044-6055


Language:
English
Keywords:
Source identifiers:
2957661
Deposit date:
2025-05-26
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