A large, multi-center randomized clinical trial has found that intravenous lidocaine does not improve the return of gut function in patients undergoing elective minimally invasive colonic surgery. The study, published in JAMA, challenges previous smaller trials and meta-analyses that suggested a potential benefit of lidocaine in accelerating postoperative recovery.
The ALLEGRO trial, conducted across 27 hospitals in the UK, involved 557 adult patients undergoing elective minimally invasive colon resection. Participants were randomized to receive either 2% intravenous lidocaine or a saline placebo during the perioperative period. The primary outcome was the proportion of patients with return of gut function at 72 hours after surgery, defined by the GI-3 composite endpoint of tolerating diet and passage of flatus or stool.
The results showed no significant difference between the lidocaine and placebo groups in the primary outcome. At 72 hours, 57.3% of patients in the lidocaine group and 59.0% in the placebo group had achieved return of gut function (adjusted absolute difference, -1.9% [95% CI, -8.0% to 4.2%]; relative risk, 0.97 [95% CI, 0.88 to 1.07]).
Secondary Outcomes
The study also assessed 11 secondary outcomes, including time to GI-3 recovery, time to GI-2 recovery, prolonged postoperative ileus, postoperative nausea and vomiting, opioid consumption, and quality of life. None of these secondary outcomes showed a significant difference between the lidocaine and placebo groups.
Study Design and Patient Population
The ALLEGRO trial enrolled adults scheduled for elective minimally invasive colon resection for benign or malignant disease. Patients received either intravenous lidocaine (1.5-mg/kg bolus followed by 1.5 mg/kg/h for 6 or 12 hours) or a saline placebo. The primary outcome was measured using the GI-3 composite endpoint, and secondary outcomes were assessed through patient questionnaires and hospital records.
Implications and Context
Delayed return of gut function after colectomy is a common barrier to timely hospital discharge, even with minimally invasive surgical techniques and enhanced recovery protocols. While lidocaine has been investigated for its potential antinociceptive and anti-inflammatory properties, this large trial did not demonstrate any significant benefit in improving gut function recovery.
"The current trial also confirms that delayed return of gut function affects a substantial proportion of patients undergoing minimally invasive colonic resection," the authors noted.
Limitations
The authors acknowledged several limitations, including the exclusion of more complex colorectal operations and the lack of a strict protocol for anesthetic or surgical technique. Additionally, the study did not include information about participant race or ethnicity or socioeconomic status.
Conclusion
The ALLEGRO trial provides strong evidence that perioperative intravenous lidocaine does not improve return of gut function after elective minimally invasive colonic surgery. These findings suggest that alternative strategies are needed to address the challenge of delayed gut function recovery in this patient population.
