Methods: United Kingdom (UK) multi-centre double blind placebo-controlled randomised controlled trial in 562 patients undergoing elective minimally invasive colorectal resection. IV lidocaine or placebo will be infused for 6– 12 h commencing at the start of surgery as an adjunct to usual analgesic/anaesthetic technique. The primary outcome will be return of GI function.
Discussion: A 6–12-h perioperative intravenous infusion of 2% lidocaine is a cheap addition to usual anaesthetic/ analgesic practice in elective colorectal surgery with a low incidence of adverse side-effects. If successful in achieving quicker return of gut function for more patients, it would reduce the rate of postoperative ileus and reduce the duration of inpatient recovery, resulting in reduced pain and discomfort with faster recovery and discharge from hospital. Since colorectal surgery is a common procedure undertaken in every acute hospital in the UK, a reduced length of stay and reduced rate of postoperative ileus would accrue significant cost savings for the National Health Service (NHS). Trial registration: EudraCT Number 2017-003835-12; REC Number 17/WS/0210 the trial was prospectively registered (ISRCTN Number: ISRCTN52352431); date of registration 13 June 2018; date of enrolment of first participant 14 August 2018.
Keywords: Colorectal surgery, Minimally invasive surgery, Recovery, Pain, Analgesia, Gastrointestinal, Intravenous lidocaine, Ileus, RCT, Protocol
The authors wish to acknowledge the following persons who have helped deliver the ALLEGRO trial: the programming team based in the Centre for Healthcare Randomised Trials, for their work in developing the study web portal; Sharon Wren and Zoe Batham for their administrative support; ACCORD in Edinburgh; the Perioperative Medicine Clinical Trials Network (POMCTN) for adopting the trial for promotion; and the local recruiting teams and participants. We are also indebted to the late Professor Kenneth Fearon, University of Edinburgh, for protocol development and study design. The views and opinions expressed herein are those of the authors and do not necessarily reflect those of the Health Technology Assessment Programme, National Institute for Health Research (NIHR), NHS or the Department of Health.
The trial is funded by the NIHR Health and Technology Assessment programme, project number 15/130/95. The funding body had no role in the design of the study, collection of data or the writing of this paper, nor will the funding body have a role in analysis, interpretation of data or in writing future manuscripts.
The co-sponsors are University of Edinburgh & Lothian Health Board (AC- CORD), The Queen’s Medical Research Institute, 47 Little France Crescent, Ed- inburgh EH16 4TJ.
Data Availability StatementNon-identifiable participant-level data may be available on request to the Chief Investigator (CI), Mr Hugh Paterson (email@example.com).
- Colorectal surgery
- Minimally invasive surgery
- Intravenous lidocaine