ALLEGRO
Trial question
What is the role of perioperative administration of intravenous lidocaine for gut function recovery in patients undergoing elective minimally invasive colon resection?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
45.0% female
55.0% male
N = 557
557 patients (249 female, 308 male).
Inclusion criteria: patients undergoing elective minimally invasive colon resection.
Key exclusion criteria: intolerance to lidocaine; complete heart block; severe hepatic dysfunction; renal impairment; IBD; use of other continuous local anesthetic infusions; certain surgical procedures; pregnancy or lactation.
Interventions
N=279 intravenous lidocaine (2% intravenous lidocaine administered as 1.5 mg/kg bolus at induction of anesthesia then 1.5 mg/kg/h for 6 or 12 hours).
N=278 placebo (0.9% saline placebo for 6 or 12 hours).
Primary outcome
Gut function recovery at 72 hours after surgery
57.3%
59%
59.0 %
44.3 %
29.5 %
14.8 %
0.0 %
Intravenous
lidocaine
Placebo
No significant
difference ↔
No significant difference in gut function recovery at 72 hours after surgery (57.3% vs. 59%; RR 0.97, 95% CI 0.88 to 1.07).
Secondary outcomes
No significant difference in time to GI-3 recovery (tolerance of diet and passage of flatus or stool) (98.6% vs. 98.9%; HR 0.98, 95% CI 0.83 to 1.17).
No significant difference in time to GI-2 recovery (tolerance of oral diet and first passage of stool) (93.5% vs. 92.1%; HR 1.03, 95% CI 0.86 to 1.23).
No significant difference in prolonged postoperative ileus (15.8% vs. 14%; IRR 1.13, 95% CI 0.8 to 1.61).
Safety outcomes
No significant differences in adverse and serious adverse events, death.
Conclusion
In patients undergoing elective minimally invasive colon resection, intravenous lidocaine was not superior to placebo with respect to gut function recovery at 72 hours after surgery.
Reference
Hugh Paterson, Thenmalar Vadiveloo, Karen Innes et al. Intravenous Lidocaine for Gut Function Recovery in Colonic Surgery: A Randomized Clinical Trial. JAMA. 2025 Jan 7;333(1):39-48.
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