Around 30,000 NHS patients undergo elective colorectal surgery each year, and one in three will experience delayed return of gut function that keeps them in hospital longer than necessary. This trial tests whether a cheap, safe, and easy-to-administer drug—intravenous lidocaine—can cut that rate. Delayed gut function is the single most common reason for extended hospital stays after colorectal surgery, affecting 20–40% of patients. Current management is largely supportive, with no reliable preventive treatment. The researchers will recruit 562 patients across 10–12 high-volume NHS units, randomly assigning them to receive either lidocaine or a saline placebo during surgery. The primary outcome is whether gut function returns by the third day after surgery. If lidocaine reduces the rate of delayed recovery by a third, the impact would be immediate and practical. Thousands of patients each year would leave hospital sooner, with less nausea, pain, and need for intravenous support. The NHS would save on bed-days and complication management. Because lidocaine is already widely used and inexpensive, the intervention could be rolled out rapidly across surgical units with no new equipment or training.
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Elective colorectal surgery is a common NHS hospital intervention (approx. 30,000 operations per year), following which delayed return of gut function is the most common cause of delayed discharge from hospital. A reduction in the current 20-40% prevalence would benefit a large number of patients with attendant reduction in health service costs related to reduced length of stay and reduced expenditure on management of the complication itself. Intravenous lidocaine is cheap, safe and easy to administer, and offers to reduce prevalence of delayed return of gut function and accelerate postoperative recovery. Study design: Multicentre double blind randomised placebo-controlled clinical trial. Treatment allocation 1:1. Stratification for laparoscopic and open colectomy using an adaptive trial design to monitor effect size and event rate in each subgroup. Intervention: iv lidocaine bolus at induction of anaesthesia (1.5mg/kg) followed by 1-2mg/kg/hr infusion for 6-12 hours. Placebo: 0.9% saline bolus/infusion Study population: patients scheduled for elective laparoscopic or open segmental colectomy. Exclusions: new stomas, rectal cancer, inability to give consent, pregnancy, age<18 years. Sample size calculation: Data from our pilot study in laparoscopic colectomy showed that 20 of 50 patients suffered gut dysfunction sufficient to prevent discharge on the third postoperative day. With a sample size of 562 randomised 1:1 to IV lidocaine or placebo the study will have 90% power at a 2-sided 5% level of significance to detect a relative reduction of 33% from 40% to 26.8% (absolute reduction of 13.2%) in gut dysfunction at 3 days post-op (or if the event rate is lower, the same power to detect a 40% relative reduction from 30% to 18% (a 12% absolute reduction)). Given the 3-day measure is in hospital there should be no appreciable loss to follow up (the perioperative death rate is ~1% for the whole duration of hospital stay and the very few discharged before 3 days can be assumed to have return of gut function). Setting: Minimising the variation generated by inconsistent perioperative care would be a key part of study design, therefore 10-12 high volume UK NHS colorectal surgery units able to implement a consistent study protocol would be invited to participate. Primary endpoint: Reduction in the proportion of participants with delayed return of gut function, defined by a validated composite endpoint (GI-3: the later of the following two events: time to tolerating solid food and time to first passage of flatus or stool. The assessment of the primary outcome on post-op day 3 will be blinded to treatment allocation. Secondary endpoints: PROMs for Quality of recovery, nausea and vomiting, pain scores; proportion of patients meeting medical criteria for discharge from hospital on postoperative day 3 (adequate oral intake without iv supplement, pain controlled with oral analgesia, no medical contraindication, willing to go home); quality of life scores; length of stay; measure of study protocol compliance; complications including iv lidocaine safety data; in-hospital, 30-day and 90-day mortality; 12 month mortality and hospital re-admission rates from record linkage into HES/eDRIS national routine data systems.
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