ALLEGRO

• Research type

  Research Study

• Full title

  A placebo controlled randomised trial of intravenous lidocaine in accelerating gastrointestinal recovery after colorectal surgery

• IRAS ID

  231280

• Contact name

  Hugh Paterson

• Contact email

  Hugh.Paterson@ed.ac.uk

• Sponsor organisation

  University of Edinburgh

• Eudract number

  2017-003835-12

• ISRCTN Number

  ISRCTN52352431

• Duration of Study in the UK

  2 years, 6 months, 1 days

• Research summary

  Summary of Research
  A common problem in about 40% of patients having bowel surgery is that their bowel takes longer than normal to start working again. In most patients the bowel will start working after surgery in 3- 4 days, but in some it takes a week or more. We call this delayed recovery of gut function. This delayed recovery causes nausea, vomiting, complete constipation, tummy pain and tummy swelling (distension). As a result, patients cannot eat or drink until gut function returns, their recovery is slower and they have to stay longer in hospital. There is no immediate cure, and although it gets better on its own in most cases, it can take from 3-7 days to do so. During this time patients have to have a continuous intravenous drip and often insertion of a nasogastric tube to empty the stomach to reduce vomiting (most patients find this very unpleasant).

  One of the common drugs used in hospitals is the local anaesthetic Lidocaine, used to “freeze” parts of the body, for example for minor skin operations or dental procedures. Recently lidocaine has been used intravenously (through the vein) as part of a general anaesthetic. It reduces pain and inflammation caused by surgery, and seems to help other aspects of recovery that may be important for return of gut function, for example reducing nausea and vomiting, and shortening the time from surgery to first bowel movement. However, previous studies were small and the true benefit of Intravenous (IV) lidocaine is uncertain. We hope to find out if giving IV Lidocaine improves recovery of gut function after colorectal surgery for NHS patients.

  Summary of Results
  Surgery to remove part of the large bowel is a common operation in UK hospitals, usually for colon cancer. Modern keyhole techniques mean that most patients are out of bed with minimal pain in a couple of days after surgery but bowel recovery (being able to eat food without nausea, and passing stool or wind) takes longer and keeps patients in hospital until it happens. Previous studies have suggested that giving patients an additional anaesthetic drug called lidocaine while they are having surgery may speed up bowel recovery after surgery.

  In the ALLEGRO study, we tested whether giving patients intravenous lidocaine (into a vein) while they were having ‘keyhole’ colorectal surgery improved bowel function recovery.

  We found that intravenous lidocaine did not improve bowel recovery. Bowel function had not recovered 3 days after surgery in 40% of patients. There was also no effect of lidocaine on pain, quality of life, other measures of recovery or on the amount of health service used after surgery.

  The results from our study show that:
  1. There is no benefit to patients of giving them lidocaine while they are having bowel surgery.
  2. Delayed recovery of bowel function is common even with keyhole surgery and we need to understand this better.

• REC name

  West of Scotland REC 1

• REC reference

  17/WS/0210

• Date of REC Opinion

  9 Oct 2017

• REC opinion

  Favourable Opinion