At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- lidocaine 2% and 10% (drug), Placebo (drug)
- How long the study runs
- Study runs about 82 months (dates as stated)
- About the drug or intervention
- lidocaine 2% and 10% — drug: Lidocaine infusion: 1. · Placebo — drug: Placebo infusion: 1.
- Patient visit burden
- Not specified by the sponsor
In plain English
The LOLIPOP trial is looking at long-term outcomes of lidocaine infusions for pain after breast cancer surgery. It involves women aged 18 or over having a mastectomy or breast conserving surgery to remove a first primary breast cancer. The sponsor is Monash University.
Who can take part
- Adult women aged 18 or over
- Having a mastectomy or breast conserving surgery (one or both breasts) under general anaesthetic (being put to sleep) to remove a first confirmed or suspected primary breast cancer, including surgery with implant or tissue expander insertion
- Fitness for surgery graded 1 to 3 on the American Society of Anaesthesiologists scale
Who may not be able to
- Surgery for breast cancer that has come back in the same area
- Surgery with extra added procedures, for example keyhole removal of the fallopian tubes
- Existing pain at the surgery site, armpit, chest wall or upper arm on the same side, before diagnosis
- Repeat surgery because the first operation did not remove enough tissue
- Reconstruction using your own body tissue, either at the same time or planned within a year
- Planned use of regional pain relief infusions (numbing medicine given through a tube near nerves)
- Problems with thinking or memory
- Pregnant or breastfeeding women
- Transgender patients
- Cancer that has spread to other parts of the body
- Serious allergy or sensitivity to lidocaine or similar numbing medicines, including people with porphyria or methaemoglobinaemia
- History of epilepsy
- Resting heart rate below 50 beats per minute or top blood pressure number below 100
- A heart attack or other serious heart event in the last three months
- Heart rhythm problems, such as atrial fibrillation, heart block, bundle branch block, long QT interval, Wolff-Parkinson-White syndrome or Brugada syndrome
- Abnormal blood potassium levels
- Active liver disease
- Taking certain medicines in the last 7 days that can slow down how the body processes lidocaine, such as amiodarone, beta blockers, cimetidine, some antibiotics and some HIV drugs
- Heart failure
- Severe kidney failure (kidneys clearing waste at less than 30ml/min, or on dialysis)
- Lidocaine given for another reason within 24 hours before surgery, for example lidocaine patches
What taking part involves
- • Not stated — ask the trial team
Time commitment: Not stated — ask the trial team
Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.
- Type of study
- Testing a treatment
- Ages
- 18 Years and over
- Who
- Female
- Number of participants
- 4,300
- Started
- 2022-07-27
- Last checked
- 2026-08
Plain English Summary
What is this study?
- • Testing a new treatment for breast cancer
- • Phase3 - 4,300 participants
- • The LOLIPOP Trial is a large (n=4,300 patients) pragmatic, international, multicentre, prospective, randomised, double blind, placebo-controlled, parallel assessment, safety and effectiveness superiority study
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with breast cancer
- • Female only
Where?
- • Wishaw - University Hospital Wishaw
- • Belfast - Belfast City Hospital
- • Bristol - Southmead Hospital, North Bristol Trust
- • Darlington - Darlington Memorial Hospital
- • +12 more UK sites
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
The LOLIPOP Trial is a large (n=4,300 patients) pragmatic, international, multicentre, prospective, randomised, double blind, placebo-controlled, parallel assessment, safety and effectiveness superiority study.
More detail
The Trial's purpose is to evaluate the effectiveness of lidocaine infusions commenced during surgery and extending up to 24 hours postoperatively, on the incidence of moderate or severe chronic post-surgical pain (CPSP) detected one year following surgery in female patients undergoing elective breast cancer surgery. The trial has 90% power to detect a clinically meaningful (25%) reduction in the incidence of the primary outcome. Secondary outcomes include safety events, analgesic efficacy (pain scores and opioid consumption), neuropathic characteristics of CPSP, and psychological and quality of life outcomes.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: Female only
What the study is looking for
- ✓American Society of Anaesthesiologist (ASA) physical scale 1-3
Who cannot take part
- ✗Mastectomy or breast conserving surgery with add on procedures e.g laparoscopic salpingectomy
- ✗Where surgery is being performed for locoregional recurrence of breast cancer
- ✗Pre-existing pain at site of surgery, axilla, ipsilateral side of chest wall or the ipsilateral upper arm (at...
- ✗Re-excision procedures where the margins at the index surgery have been deemed insufficient
- ✗When immediate autologous reconstruction surgery is planned
See the full criteria
Where Is This Study? (16 UK sites)
University Hospital Wishaw
Wishaw, United Kingdom
Belfast City Hospital
Belfast BT9 7AB, United Kingdom
Southmead Hospital, North Bristol Trust
Bristol BS10 5NB, United Kingdom
Darlington Memorial Hospital
Darlington DL3 6HX, United Kingdom
Research and Development Team cdda-tr.Research@nhs.net
nencadmin@nihr.ac.uk01325 743366Russells Hall Hospital
Dudley DY1 2HQ, United Kingdom
Royal Liverpool and Broadgreen Hospitals
Liverpool, United Kingdom
Whittington Hospital
London N19 5NF, United Kingdom
Royal Marsden Hospital - London and Sutton
London, United Kingdom
Newcastle upon Tyne Hospitals
Newcastle upon Tyne, United Kingdom
Norfolk and Norwich University Hospital
Norwich NR4 7UY, United Kingdom
Rotherham NHS Foundation Trust
Rotherham S60 2UD, United Kingdom
Royal Hallamshire Hospital
Sheffield S10 2JF, United Kingdom
University Hospital Southampton
Southampton, United Kingdom
St Helen's Hospital
St Helens WA9 3DA, United Kingdom
Torbay Hospital
Torquay TQ2 7AA, United Kingdom
Royal Hampshire County Hospital
Winchester SO22 5DG, United Kingdom
How to Get in Touch
Gillian Ormond
Sponsor contactCONTACT
Natalie Hird
Sponsor contactCONTACT
