LOLIPOP (Long term Outcomes of Lidocaine Infusions for Post-Operative Pain)
Research type
Research Study
Full title
Long-term Outcomes of Lidocaine Infusions for persistent Post-Operative Pain in patients undergoing breast surgery (LOLIPOP) Trial
IRAS ID
1008025
Contact name
Mark Edwards
Contact email
Sponsor organisation
University Hospital Southampton NHS Foundation Trust
Clinicaltrials.gov Identifier
Research summary
When patients undergo surgery they may experience lots of pain around the area operated on. In some cases patients pain can last for years, and cannot be helped with medicine, which lowers quality of life. This is particularly common after breast cancer surgery, with 1 in 4 women reporting significant pain many years later. There are currently no established treatments that prevent persistent pain after surgery. Local anaesthetics are drugs that give pain relief to the area in which they are applied. The LOLIPOP Trial aims to test whether a type of anaesthetic, lidocaine, given via a drip during breast cancer surgery and for up to 24 hours afterwards reduces the number of patients reporting significant pain one year after their surgery.
LOLIPOP is a clinical trial where participants have a random equal chance of receiving lidocaine or placebo (salt water, with no medicine in it). The placebo is used so that clinical staff, research teams, and participants do not know what they receive until participants have reported on pain one year later and the study has finished. This helps make a fair assessment of whether the lidocaine has worked. The UK team will recruit over 1,000 adult females undergoing breast cancer surgery for the first time in at least 10 NHS hospitals. A drip of lidocaine or salt water into the bloodstream will start after the patient is asleep, before the operation starts. It will continue during surgery and for up to 24 hours after, depending if the patient is staying overnight or not. The main outcome will be significant persistent pain at one year. We will also assess side-effects and any improvements in other painkiller use, quality of life, physical activity and emotional wellbeing. Information on costs and savings in the NHS related to this treatment will be reported. The trial will last for 5 years in the UK. The trial is also being conducted in Australia, New Zealand and Hong Kong.REC name
East of England - Cambridge Central Research Ethics Committee
REC reference
24/EE/0104
Date of REC Opinion
8 Jul 2024
REC opinion
Further Information Favourable Opinion