The ALLEGRO trial: a placebo controlled randomised trial of intravenous lidocaine in accelerating gastrointestinal recovery after colorectal surgery

Hugh  Paterson; Seonaidh Cotton; John  Norrie; Susan Nimmo; Irwin Foo; Angie Balfour; Doug  Speake; Graeme MacLennan; Andrew Stoddart; Karen Innes; Sarah Cameron; Lorna Aucott; Kirsty McCormack

doi:10.1186/s13063-022-06021-5

The ALLEGRO trial: a placebo controlled randomised trial of intravenous lidocaine in accelerating gastrointestinal recovery after colorectal surgery

Hugh Paterson, Seonaidh Cotton, John Norrie, Susan Nimmo, Irwin Foo, Angie Balfour, Doug Speake, Graeme MacLennan, Andrew Stoddart, Karen Innes^*, Sarah Cameron, Lorna Aucott, Kirsty McCormack

^*Corresponding author for this work

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Abstract

Background: Return of gastrointestinal (GI) function is fundamental to patient recovery after colorectal surgery and is required before patients can be discharged from hospital safely. Up to 40% of patients suffer delayed return of GI function after colorectal surgery, causing nausea, vomiting and abdominal discomfort, resulting in longer hospital stay. Small, randomised studies have suggested perioperative intravenous (IV) lidocaine, which has analgesic and anti-inflammatory effects, may accelerate return of GI function after colorectal surgery. The ALLEGRO trial is a pragmatic effectiveness study to assess the benefit of perioperative IV lidocaine in improving return of GI function after elective minimally invasive (laparoscopic or robotic) colorectal surgery.
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

Original language	English
Article number	84
Number of pages	13
Journal	Trials
Volume	23
Issue number	1
DOIs	https://doi.org/10.1186/s13063-022-06021-5
Publication status	Published - 28 Jan 2022

Bibliographical note

Acknowledgements
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.

Funding
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 Statement

Non-identifiable participant-level data may be available on request to the Chief Investigator (CI), Mr Hugh Paterson (hugh.paterson@ed.ac.uk).

Keywords

Colorectal surgery
Minimally invasive surgery
Recovery
Pain
Analgesia
Gastrointestinal
Intravenous lidocaine
Ileus
Protocol
RTC

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Paterson, H., Cotton, S., Norrie, J., Nimmo, S., Foo, I., Balfour, A., Speake, D., MacLennan, G., Stoddart, A., Innes, K., Cameron, S., Aucott, L., & McCormack, K. (2022). The ALLEGRO trial: a placebo controlled randomised trial of intravenous lidocaine in accelerating gastrointestinal recovery after colorectal surgery. Trials, 23(1), Article 84. https://doi.org/10.1186/s13063-022-06021-5

Paterson, H, Cotton, S, Norrie, J, Nimmo, S, Foo, I, Balfour, A, Speake, D, MacLennan, G, Stoddart, A, Innes, K, Cameron, S, Aucott, L & McCormack, K 2022, 'The ALLEGRO trial: a placebo controlled randomised trial of intravenous lidocaine in accelerating gastrointestinal recovery after colorectal surgery', Trials, vol. 23, no. 1, 84. https://doi.org/10.1186/s13063-022-06021-5

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abstract = "Background: Return of gastrointestinal (GI) function is fundamental to patient recovery after colorectal surgery and is required before patients can be discharged from hospital safely. Up to 40% of patients suffer delayed return of GI function after colorectal surgery, causing nausea, vomiting and abdominal discomfort, resulting in longer hospital stay. Small, randomised studies have suggested perioperative intravenous (IV) lidocaine, which has analgesic and anti-inflammatory effects, may accelerate return of GI function after colorectal surgery. The ALLEGRO trial is a pragmatic effectiveness study to assess the benefit of perioperative IV lidocaine in improving return of GI function after elective minimally invasive (laparoscopic or robotic) colorectal surgery. 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",

keywords = "Colorectal surgery, Minimally invasive surgery, Recovery, Pain, Analgesia, Gastrointestinal, Intravenous lidocaine, Ileus, Protocol, RTC",

author = "Hugh Paterson and Seonaidh Cotton and John Norrie and Susan Nimmo and Irwin Foo and Angie Balfour and Doug Speake and Graeme MacLennan and Andrew Stoddart and Karen Innes and Sarah Cameron and Lorna Aucott and Kirsty McCormack",

note = "Acknowledgements 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. Funding 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{\textquoteright}s Medical Research Institute, 47 Little France Crescent, Ed- inburgh EH16 4TJ.",

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AU - Paterson, Hugh

AU - Cotton, Seonaidh

AU - Norrie, John

AU - Nimmo, Susan

AU - Foo, Irwin

AU - Balfour, Angie

AU - Speake, Doug

AU - MacLennan, Graeme

AU - Stoddart, Andrew

AU - Innes, Karen

AU - Cameron, Sarah

AU - Aucott, Lorna

AU - McCormack, Kirsty

N1 - Acknowledgements 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. Funding 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.

PY - 2022/1/28

Y1 - 2022/1/28

N2 - Background: Return of gastrointestinal (GI) function is fundamental to patient recovery after colorectal surgery and is required before patients can be discharged from hospital safely. Up to 40% of patients suffer delayed return of GI function after colorectal surgery, causing nausea, vomiting and abdominal discomfort, resulting in longer hospital stay. Small, randomised studies have suggested perioperative intravenous (IV) lidocaine, which has analgesic and anti-inflammatory effects, may accelerate return of GI function after colorectal surgery. The ALLEGRO trial is a pragmatic effectiveness study to assess the benefit of perioperative IV lidocaine in improving return of GI function after elective minimally invasive (laparoscopic or robotic) colorectal surgery. 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

AB - Background: Return of gastrointestinal (GI) function is fundamental to patient recovery after colorectal surgery and is required before patients can be discharged from hospital safely. Up to 40% of patients suffer delayed return of GI function after colorectal surgery, causing nausea, vomiting and abdominal discomfort, resulting in longer hospital stay. Small, randomised studies have suggested perioperative intravenous (IV) lidocaine, which has analgesic and anti-inflammatory effects, may accelerate return of GI function after colorectal surgery. The ALLEGRO trial is a pragmatic effectiveness study to assess the benefit of perioperative IV lidocaine in improving return of GI function after elective minimally invasive (laparoscopic or robotic) colorectal surgery. 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

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KW - RTC

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JO - Trials

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ER -

The ALLEGRO trial: a placebo controlled randomised trial of intravenous lidocaine in accelerating gastrointestinal recovery after colorectal surgery

Abstract

Bibliographical note

Data Availability Statement

Keywords

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