A Phase 3 interventional study of lidocaine 2% and 10% and Placebo in Breast Cancer, Breast Cancer Female and Breast Conserving Surgery, sponsored by Monash University. Recruiting at 49 sites in 4 countries. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-12.
Sponsored by Monash University · Phase 3, Interventional, and Prevention
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.
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.
14,825 studies on the registry are indexed under Breast Neoplasms; 3,319 are open to participants now.
This study's planned enrollment of 4,300 is above the median of 72 across 10,896 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Monash University is the lead sponsor of 83 studies on the registry; 22 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
2% Lidocaine infusion intra-operative and 10% Lidocaine infusion post-operative.
Drug: lidocaine 2% and 10%
0.9% Saline infusion intra-operative and 0.9% Saline infusion post-operative.
Drug: Placebo
Drug page: Lidocaine
Lidocaine infusion: 1. Commencing with an intravenous bolus after induction of anaesthesia, 0.125 ml/kg of lean body weight (LBW) of 2% lidocaine (2.5 mg/kg).\* 2. Followed by a 2% lidocaine intravenous infusion for the duration of surgery, 0.1665 ml/kg/h of LBW (3.33 mg/kg/hr).\* 3. A post-operative subcutaneous 0.0222 ml/kg/hr of LBW 10% lidocaine infusion for up to 24 hours thereafter (2.22 mg/kg/hr). Dosage will be capped at a maximum lean body weight of 68kg. * \*Day-case surgery receives intraoperative bolus and intraoperative infusion only
Also known as: Xylocaine (lidocaine) 2% and Xylocard (lidocaine) 10%
Placebo infusion: 1. Commencing with an intravenous bolus after induction of anaesthesia, 0.125 ml/kg of lean body weight (LBW) of 0.9% Saline solution.\* 2. Followed by a 0.9% Saline solution intravenous infusion for the duration of surgery, 0.1665 ml/kg/h of LBW (3.33 mg/kg/hr).\* 3. A post-operative subcutaneous 0.0222 ml/kg/hr of LBW 0.9% Saline solution infusion for up to 24 hours thereafter (2.22 mg/kg/hr). Dosage will be capped at a maximum lean body weight of 68kg. * \*Day-case surgery receives intraoperative bolus and intraoperative infusion only
Also known as: 0.9% Saline solution
The incidence of moderate or severe CPSP at 1 year after surgery, as reported by the patient at the follow-up review.
Numerical rating scale ≥4 out of 10 for worst pain in the last week - The pain must have been present for at least 3 months prior to the one year assessment (or longer).
Time frame: 1 year post-surgery
The incidence of severe CPSP at 1 year after surgery
NRS for worst pain the in the last week of ≥7)
Time frame: 1 year post surgery
Severity of pain at the site of surgery
Assessed using "average" and "worst" NRS pain score in the last week, obtained from the adapted modified Brief Pain Inventory-Short Form (mBPI-SF)
Time frame: 1 year post surgery
Incidence of neuropathic symptoms
Incidence examined as a binary outcome using the Short Form of Douleur Neuropathique 4 Questions (S-DN4)
Time frame: 1 year post surgery
Physical functioning
Using interference component of mBPI-SF
Time frame: 1 year post surgery
Changes in quality of life metrics EuroQol 5 Dimension 5 Level (EQ-5D-5L) at 1 year after surgery compared to baseline
Changes in the quality of life
Time frame: 1 year post surgery
Changes in psychological wellbeing Kessler Psychological Distress Scale (K-10) at 1 year after surgery compared to baseline.
Changes in psychological wellbeing
Time frame: 1 year post surgery
The incidence of mild or greater pain at the site of surgery at 1 year after surgery
NRS for worst pain the in the last week of ≥1
Time frame: 1 year post surgery
The incidence of discomfort or altered sensation at the site of surgery (not reported as pain)
Patients asked if they have any altered sensation at the site of surgery
Time frame: 1 year post surgery
Severity of acute postoperative pain at rest
Maximum pain score, Numerical rating scale (NRS) 0-10
Time frame: 24 hours postoperatively
Severity of Acute postoperative pain on movement
Maximum pain score, Numerical rating scale (NRS) 0-10
Time frame: 24 hours postoperatively
Postoperative opioid consumption
Morphine Equivalent Opioid Consumption (MEQ)
Time frame: on Day 1
Postoperative opioid consumption
Morphine Equivalent Opioid Consumption (MEQ)
Time frame: 3 months (last 24-hours)
Postoperative opioid consumption
Morphine Equivalent Opioid Consumption (MEQ)
Time frame: 1 year post surgery (last 24 hours)
The incidence of mortality at 1 year
Mortality at 1 year
Time frame: 1 year post surgery
UK NHS costs of care over 1 year following surgery
UK/NHS sites only
Time frame: 1 year post surgery
Productivity costs over 1 year following surgery
UK/NHS sites only
Time frame: 1 year post surgery
Quality-adjusted life years (QALYs) over 1 year following surgery
UK/NHS sites only
Time frame: 1 year post surgery
Cost-effectiveness of perioperative lidocaine infusions compared to usual care, from a primary UK NHS perspective and broader perspective including productivity, at 1 year.
UK/NHS sites only
Time frame: 1 year post surgery
Incidence of treated bradycardia intraoperatively
Drug related safety Endpoints
Time frame: 24 hours postoperatively
Incidence of treated hypotension intraoperatively
Drug related safety Endpoints
Time frame: 24 hours postoperatively
Incidence of treated bradycardia in Post Anaesthesia Care Unit (PACU)
Drug related safety Endpoints
Time frame: 24 hours postoperatively
Incidence of treated hypotension in Post Anaesthesia Care Unit (PACU)
Drug related safety Endpoints
Time frame: 24 hours postoperatively
Incidence of intraoperative infusion stopping events
Drug related safety Endpoints
Time frame: 24 hours postoperatively
Incidence of Post Anaesthesia Care Unit (PACU) infusion stopping events
Drug related safety Endpoints, (x2 symptoms, x1 sign, x1 complication)
Time frame: 24 hours postoperatively
Incidence of postoperative infusion stopping events on the ward
Drug related safety Endpoints, (x2 symptoms, x1 sign, x1 complication)
Time frame: 24 hours postoperatively
Incidence of suspected lidocaine toxicity events
Drug related safety Endpoints
Time frame: 24 hours postoperatively
Incidence of suspected SEVERE lidocaine toxicity events
Drug related safety Endpoints, (generalised seizure, sudden unexplained LOC, life-threatening arrhythmia, or asystole, cardiac or circulatory arrest)
Time frame: 24 hours postoperatively
Incidence of Medical Emergency Team (MET) activation
Drug related safety Endpoints
Time frame: 24 hours postoperatively
Incidence of unplanned Intensive Care Unit (ICU), High Dependency Unit (HDU) or Critical Care Unit (CCU) admission
Drug related safety Endpoints
Time frame: 24 hours postoperatively
Incidence of study drug unblinding events
Drug related safety Endpoints
Time frame: 24 hours postoperatively
Incidence of subcutaneous catheter site events
Drug related safety Endpoints
Time frame: Day 30
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Plan to share: No
Started Jul 2022 (actual). Primary completion is estimated for May 2028, 70 months after the start.
Of 328 non-industry phase 3 interventional studies under Breast Neoplasms, half reached primary completion within 79 months of starting (the median), counting those still running; a quarter within 50 and three quarters within 127. This study's planned 70 months is below that.
Counting every sponsor, half of 600 studies reached it within 59 months; a quarter within 36 and three quarters within 96.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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Studies of the drug tested here: Lidocaine
Monash University