Lidocaine Fails to Speed Up Gut Function Recovery After Colonic Surgery

Perioperative lidocaine failed to speed up the recovery of gut function following minimally invasive colonic resections, a randomized U.K. trial showed.

In patients undergoing elective procedures for benign or malignant disease, 57.3% of those randomized to intravenous (IV) lidocaine had a return of gut function at 72 hours after surgery, as compared with 59% with placebo (relative risk 0.97, 95% CI 0.88-1.07), reported researchers led by Hugh Paterson, MD, of Western General Hospital in Edinburgh, Scotland.

And no significant differences were observed for any secondary endpoint, including prolonged postoperative ileus (15.8% vs 14%, respectively), length of hospital stay (mean 6 vs 5.8 days), and measures of postoperative pain, quality of life, and quality of recovery, according to the findings in JAMA.

Over 600,000 colonic resections are performed in the U.S. each year, and the failure to recover gut function is the primary reason for extended hospital stays. Furthermore, up to 15% of these resections result in cases of postoperative ileus that require inpatient care until gut function returns.

“Lidocaine has been used intravenously as an adjunct to general anesthesia during various types of surgery and has been found to reduce early postoperative pain scores and opioid requirements,” said Paterson and co-authors in explaining the rationale for their study. “Lidocaine’s mechanism of action on the gastrointestinal tract is unknown, but may be partly mediated by opiate sparing.”

The new findings contrast with those from two smaller, single-center trials from Europe that showed quicker gut function recovery and shorter hospital stays with the anesthetic. However, the current multicenter trial included “a patient cohort that was older, had more comorbidities, and were more likely to be undergoing surgery for colorectal cancer than benign disease,” the study authors noted.

From 2018 to 2023, the double-blind ALLEGRO trial enrolled 590 adults scheduled for elective, minimally invasive colon resection across 27 hospitals in the U.K. Patients were randomized 1:1 to either IV lidocaine (2% bolus plus infusion for 6 or 12 hours) or saline placebo.

After exclusions, 557 patients were included in the primary analysis. Participants had a mean age of 66 years, 45% were women, and 96% received lidocaine or placebo as assigned. Mean body mass index was 28.0 in both groups. The most common operation type was right hemicolectomy (49%) followed by high anterior resection (31%).

The primary outcome was defined by the GI-3 composite endpoint of tolerating diet without significant nausea or vomiting over three meals in a row, along with the passage of gas or stool. No prespecified subgroups — including age group, sex, right versus nonright colectomy, 6- or 12-hour lidocaine infusion, or enhanced recovery protocol adherence — showed benefit.

In addition, there were no significant differences for any of the 11 secondary endpoints, which also included time to GI-3 outcome and GI-2 recovery, postoperative nausea and vomiting, intraoperative and postoperative opioid use, and meeting clinician or self-assessed criteria for discharge.

About 12% of the operations were converted intraoperatively to open surgery.

Adverse events (AEs) occurred in 14.3% of patients assigned to lidocaine and 13.3% of those assigned placebo, while serious AEs occurred in 1.4% and 3.2%, respectively. Clavien-Dindo grade ≥3 perioperative complications occurred in 4.7% and 4.3%.

“Although this study reported no adverse events attributable to lidocaine using this administration schedule, there is ongoing concern that its use carries a risk of systemic toxicity and death,” Paterson and co-authors noted.

Mortality rates at 30 days were 0.4% in the lidocaine group and 0.7% in the placebo group, while 90-day rates were 0.7% and 1.1%. Unplanned readmissions occurred in 11.1% and 12.2%, respectively.