A placebo-controlled rAndomised trial of intravenous Lidocaine in acceLErating Gastrointestinal Recovery after cOlorectal surgery (ALLEGRO)

Return of gut function is fundamental to recovery after major colorectal surgery but is delayed in up to 40% of patients, manifesting as nausea, vomiting, constipation and abdominal distension. It is the most frequent reason for delayed recovery after laparoscopic colectomy. There is currently no remedy to induce return of gut function; treatment is supportive until gut function returns spontaneously (IV fluids, nasogastric tube insertion and analgesia). Affected patients can spend 1-10 extra days in hospital compared to those who have a straightforward recovery.

IV lidocaine has anti-inflammatory properties, is opioid-sparing and induces a sense of well-being. Small studies suggest it may improve isolated components of GI recovery including nausea and time from surgery to first bowel movement.

ALLEGRO aims to be the definitive trial to test whether 6-12 hours of perioperative IV lidocaine accelerates return of GI function after colorectal resection in the NHS. The primary study is powered to test the primary hypothesis in laparoscopic segmental colectomy and will recruit 562 patients from 12-15 hospitals over 3 years. We will also test the intervention in a parallel feasibility trial in open segmental colectomy patients using adaptive analysis to assess recruitment and effect size.

The primary study outcome will be return of gut function at 72 hours after surgery defined by a validated composite endpoint. Secondary outcomes will include other patient-reported aspects of recovery; pain scores and analgesia consumption; length of stay; safety endpoints; and health economic analysis.

ALLEGRO is funded by NIHR-HTA and has a website containing more information.

  • Chief Investigator: Mr Hugh Paterson, University of Edinburgh
  • Interested in this trial? Contact us.