Up to 27% of women who undergo breast cancer surgery in the UK develop chronic pain that persists for a year or more, and a large clinical trial is now testing whether a simple infusion of the common anaesthetic lidocaine can prevent it. This matters because chronic post-surgical pain (CPSP) is not a rare side effect—it affects roughly one in four patients, damages quality of life, contributes to mood disorders, and fuels reliance on opioid painkillers. The condition is now classified in the ICD-11 manual and ranks among the top ten UK research priorities for perioperative care. Small trials have consistently flagged lidocaine infusion as the most promising preventative agent, but no large-scale, definitive study has been done in the NHS, where day-case surgery limits the opportunity for prolonged infusion. If the trial shows lidocaine is superior to placebo, the results could change standard surgical care across the NHS. The infusion protocol and monitoring tools are already designed for immediate translation into practice, where current uptake is below 25%. A positive outcome would give surgeons a cheap, safe, and readily available tool to cut the number of women left with lasting pain after breast cancer surgery.
View original technical description
BACKGROUND: Moderate or severe Chronic Post-Surgical Pain (CPSP) affects up to 27% of patients undergoing breast cancer surgery in the UK and contributes to low quality of life, mood disturbance and the opioid epidemic. This has led to a specific listing in the ICD-11 manual and prominence in the top-ten UK research priorities for perioperative care. Lidocaine, the commonly used local anaesthetic agent, modulates several of the pathophysiological processes involved in CPSP. Across multiple systematic reviews of small CPSP trials, perioperative systemic lidocaine infusion is consistently identified as the most promising preventative agent. The LOLIPOP RCT has started recruitment in Australasia to test this intervention in breast cancer surgery. International differences in care pathways - particularly day case breast surgery in the UK, with less opportunity for prolonged postoperative lidocaine infusion - mean that substantial UK recruitment is needed to generalise the trial findings to the NHS. AIM 1: Test the primary hypothesis that lidocaine infusion intraoperatively and up to 24h postoperatively will decrease the incidence of moderate or severe CPSP 1 year after primary breast cancer surgery. AIM 2: To provide UK-specific efficacy, safety and cost-effectiveness data. METHODS: UK arm of an established, pragmatic, international, multi-centre, randomised, placebo-controlled, safety and superiority trial with quadruple blinding, internal pilot and patient follow-up for 1 year. Adult females undergoing mastectomy or breast conserving surgery for the primary excision of cancer in NHS hospitals will be enrolled; n=1,000, representing =20% of the international sample size of 4,300. Participants will be randomised (1:1) to lidocaine or matched placebo (0.9% saline) infusion dosed on lean body weight and starting intravenously (2.5mg/kg bolus then 3.33 mg/kg/h) before surgical incision and continuing subcutaneously (2.22 mg/kg/h) for up to 24h postoperatively (less if discharged). We will use trial processes that exhibited excellent safety, effectiveness and feasibility in our external multi-centre pilot (n=150). The primary outcome is the patient reported incidence of moderate or severe CPSP 1 year after surgery using a numerical rating scale (NRS 0-10) =4/10 for worst pain in the last 7 days. Secondary outcomes include: pain character/severity; opioid consumption; physical functioning; quality of life; psychological wellbeing; and safety endpoints. A UK economic evaluation will be conducted from an NHS perspective at 1 year. TIMELINES: International study ends in January 2029. Study duration in UK is 60 months from January 2024 to January 2029: 4 months set-up; 38 months recruitment (12-month internal pilot); 12 months follow-up; 6 months analysis/report. Target randomisation 2.6 patients/centre/month across 10 centres. IMPACT AND DISSEMINATION: If lidocaine infusion is shown to be superior we will engage with stakeholders to drive a new standard of care through clinical guidance and expanded licensing. Our novel infusion and surveillance tools are immediately translatable into NHS practice where current uptake is low (pre-trial survey <25%). Results will be rapidly disseminated to stakeholders via publication in peer-reviewed journals, webinars and media. Specialists will be further targeted with conference presentations and communications via clinical trials networks. Patient groups will be informed by consumer representatives.
Plain English summaries and category classifications on this site are generated by AI and may not perfectly reflect the original research.
Is something wrong? Let us know