Moderate or severe chronic post-surgical pain (CPSP), defined as pain persisting more than 3 months after the procedure, affects over 1 in 4 patients undergoing breast cancer surgery. This is a long-term problem which may lead to low mood and dramatically impact a patient’s quality of life. Interventions to prevent CPSP are lacking, and developing strategies to address this is a top 10 research priority for perioperative care.
The international phase 3 LOLIPOP randomised controlled trial aims to determine whether the local anaesthetic lidocaine given intravenously during and immediately after the procedure may be an effective strategy for reducing CPSP after breast cancer surgery. LOLIPOP aims to recruit a total of 4300 participants, randomised 1:1 to lidocaine vs placebo from Australasia, Hong Kong and the UK between July 2022 and 2027. International recruitment is vital as the length of hospital stay following breast cancer surgery and thus the duration of lidocaine infusion possible differs across healthcare settings. UK recruitment is key as most UK patients have daycase procedures, and a key objective is to determine whether the shorter infusions given to UK patients are as effective at reducing CPSP as those given overnight, to increase the generalisability of the trial findings overall.
The UK arm of the LOLIPOP study will recruit a minimum of 1000 participants from around 14 sites, using the daycase pathway only. Recruitment began in October 2024 and currently stands at around 340 participants.
Population
Adult female patients undergoing elective breast cancer surgery
Intervention
Lidocaine infusion: intraoperative bolus followed by an intravenous infusion given during surgery and for up to one hour after
Control
Saline placebo infusion: intraoperative bolus followed by an intravenous infusion given during surgery and for up to one hour after
Primary outcome
Incidence of moderate or severe CPSP at 1 year after surgery, as reported by the patient on the pain NRS score
Secondary outcome
Acute pain metrics – measured using the pain NRS score provided by the patient
CPSP nature (severity and neuropathic features) – measured using the NRS pain score, mBPI-SF and S-DN4 questionnaires
Physical functioning – measured using the mBPI-SF questionnaire
Quality of life – measured using the EQ-5D-5L questionnaire
Psychological wellbeing – measured using the K-10 questionnaire
One year mortality
Cost-effectiveness of perioperative lidocaine infusions in this setting (UK only) – measured using data from CRFs, WPAI and ModRUM questionnaires.
How can surgeons get involved in the trial?
LOLIPOP-UK is looking to open one additional site. Surgeons or Anaesthetists can be site Principal Investigators. Email us at lolipop-trial@bristol.ac.uk if you are interested and for further details.
The UK trial is led by:
UK Chief Investigator: Prof Mark Edwards, Consultant Anaesthetist
UK Surgical Lead: Prof Shelley Potter, Consultant Oncoplastic Breast Surgeon
Learn more
This project is funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme (project reference NIHR159174). The views expressed are those of the authors and not necessarily those of the NIHR or the Department of Health and Social Care.
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