Professor Tomás Corcoran (Monash University and Royal Perth Hospital)
Please email complete this form if you are interested in taking part in the LOLIPOP trial.
The start-up meeting was held at the ANZCA CTN workshop on Saturday 7 August 2021. To get a copy of the recording, email Gillian Ormond.
Women undergoing breast surgery and cancer treatment are a high-risk group for development of chronic postsurgical pain (CPSP), where it is estimated that nearly half of breast cancer surgery patients may develop this outcome. A systematic review and meta-analysis by the study team observed a 71% reduction of the odds of CSPS (odds ratio [OR], 0.29; 95% CI, 0.18 to 0.48) with a number-needed-to-treat (NNT) of approximately 5 for lidocaine infusions - a finding that remained consistent in a planned sub-group analysis limited to breast surgery. The primary purpose of a meta-analysis where there is insufficient evidence is in hypothesis generation and to identify equipoise. Hence, this very substantial reduction in the odds of CPSP must be tested in a properly conducted large trial. The team has published the results of the LOLIPOP pilot trial. This trial enrolled 150 patients and examined feasibility and safety outcomes in addition to pharmacokinetic data, in preparation for the large international multicentre trial.
In our recent survey of ANZCA Fellows, 52% of respondents reported the incorporation of perioperative lidocaine into their practice, with the principal aim to reduce acute surgical pain and opioid use. These findings, in addition to the results of the metaanalysis, confirm that there is equipoise regarding lidocaine as a perioperative intervention. This trial will inform clinical practise globally.
The LOLIPOP trial is a multicentre, pragmatic, double-blind, randomised trial that will compare the incidence of chronic post-surgical pain after breast cancer surgery in patients receiving a 24-hour infusion of lidocaine or placebo.
Adult females undergoing unilateral elective surgery for a confirmed or suspected breast cancer diagnosis with no pre-existing pain at the operative site. Surgery involving immediate, autologous reconstruction is excluded.
Lidocaine infusion (or matched placebo) commencing with an intravenous bolus after induction of anaesthesia (2.5 mg per Kg lean body weight), followed by an intravenous infusion for the duration of surgery (3.33 mg per Kg per hour) and a subcutaneous infusion for 24 hours thereafter (2.22 mg per Kg per hour).
Chronic post-surgical pain at 1 year that is moderate or severe in severity that has been present for three months or more at the time of review.
Chronic post-surgical pain of any severity; analgesic consumption; quality of life; surgical site infection; cancer recurrence.
Incidence of hypotension and bradycardia requiring treatment, incidence of infusion stopping events, incidence of suspected lidocaine toxicity events, incidence of suspected severe local anaesthetic toxicity events (generalised seizure, sudden unexplained loss of consciousness, life-threatening arrhythmia, cardiac arrest), and other adverse events.
Medical Research Future Fund grant $A4.3 million (2021-2025).
Prof Tomás Corcoran
A/Prof Andrew Toner
Ms Gillian Ormond
Ms Natalie Hird
Ms Paige Druce
Monash University, Melbourne
Royal Perth Hospital, Perth
Australian and New Zealand College of Anaesthetists Clinical Trials Network (ANZCA CTN)
Recruitment for the LOLIPOP trial is underway. There are 21 active sites in Australia, one active site in New Zealand and one active site in Hong Kong.
We will hope to have a further site in New Zealand and two further sites in Australia up and running shortly.
We thank all of our sites and the LOLIPOP patients for their ongoing support of the trial.
ClinicalTrials.gov identifier: NCT05072314