Breast CancerPhase 3LOLIPOPNCT05072314
Long-term Outcomes of Lidocaine Infusions for Post-Operative Pain (LOLIPOP) Trial
A Phase 3 study testing lidocaine 2% and 10% in people with Breast Cancer and Breast Cancer Female, run by Monash University at 49 sites in 4 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer, Breast Cancer Female, Breast Conserving Surgery
- What is being tested?
- lidocaine 2% and 10%
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 4,300 participants
- Where
- 49 sitesin 4 countries
- Study dates
- 27 Jul 2022to May 2029
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Consenting adult female patients (≥18 years) undergoing mastectomy (unilateral or bilateral) or breast conserving surgery (unilateral or bilateral) for the primary excision of confirmed or suspected primary breast cancer under general anaesthesia (including those with simultaneous insertion of tissue expanders or implants)*. * this specifically excludes patients undergoing surgery for locoregional recurrence
- American Society of Anaesthesiologist (ASA) physical scale 1-3
Who cannot join
- 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 diagnosis prior to any tumor locating procedures)
- Re-excision procedures where the margins at the index surgery have been deemed insufficient
- When immediate autologous reconstruction surgery is planned
- Where delayed autologous reconstruction surgery on the operative breast within one year is planned
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- Planned use of regional analgesia infusions
- Impaired cognition
- Pregnant or lactating females
- Transgender patients
- Known metastatic disease
- History of anaphylaxis, sensitivity or known contraindication to lidocaine (or other amide local anaesthetic agents e.g. other amide local anaesthetic agents: ropivacaine, bupivacaine, mepivacaine, prilocaine, etidocaine), including patients with porphyria or methaemoglobinaemia
- History of epilepsy
- Baseline heart rate \< 50 bpm or systolic blood pressure \< 100mmHg.
- Acute coronary event in the last three months
- Cardiac conduction abnormalities, including; Atrial fibrillation, Heart block (all degrees), Bundle Branch Block or Fascicular block, Prolonged QT interval, Wolf Parkinson White syndrome, channelopathy such as Brugada syndrome. A preoperative Electrocardiogram (ECG) is not mandatory, unless clinically indicated
- Abnormal serum potassium concentration (based upon site laboratory reference ranges)
- Active liver disease e.g. viral hepatitis, alcoholic liver disease, non-alcoholic fatty liver disease, haemochromatosis, other rarer causes)
- Medications within the last 7 days which are known / suspected to slow lidocaine metabolism (amiodarone, beta blockers, cimetidine, fluoroquinolones, fluvoxamine, imidazoles, macrolides, verapamil, HIV drugs)
- Cardiac Failure (any documented heart failure at peroperative assessment or GP records)
- Severe Renal Failure (Creatinine Clearance of less than 30ml/min or dialysis dependent)
- Co-administration of lidocaine within 24 hours prior to surgery for other reasons (e.g. lidocaine patches
Trial locations and contacts
49 sites in 4 countries. Contact the study team or a site near you to ask about taking part.
49 sites in 4 countries
Australia27 sites, 19 recruiting
- Terminated
Anaesthetic Group Ballarat
Ballarat, Victoria, 3350
- Recruiting
Ballarat Health Services (Grampians Health)
Ballarat, Victoria, 3350
- Recruiting
Flinders Medical Centre
Bedford Park, South Australia, 5042
- Recruiting
Bentley Health Service
Bentley, Western Australia, 6102
- Terminated
Royal Brisbane and Women's Hospital
Brisbane, Queensland, 4029
- Recruiting
Queen Elizabeth II Jubilee Hospital
Coopers Plains, Queensland, 4108
- Recruiting
Barwon Health - University Hospital Geelong
Geelong, Victoria, 3220
- Recruiting
Royal Hobart Hospital
Hobart, Tasmania, 7000
- Recruiting
Nepean Hospital
Kingswood, New South Wales, 2747
- Recruiting
Mackay Base Hospital
Mackay, Queensland, 4740
- Recruiting
The Alfred
Melbourne, Victoria, 3004
- Recruiting
Royal Melbourne Hospital
Melbourne, Victoria, 3050
- Recruiting
St Vincent's Hospital Melbourne
Melbourne, Victoria, 3065
- Withdrawn
Northern Hospital
Melbourne, Victoria, 3076
- Terminated
Monash Health - Moorabbin Hospital
Melbourne, Victoria, 3165
- Recruiting
Blacktown Mount Druitt Hospital
Mount Druitt, New South Wales, 2770
- Recruiting
Royal Perth Hospital
Perth, Western Australia, 6000
- Recruiting
St John of God Subiaco
Perth, Western Australia, 6008
- Recruiting
Maroondah Hospital - Eastern Health
Ringwood East, Victoria, 3135
- Terminated
Rockhampton Hospital
Rockhampton, Queensland, 4700
- Terminated
Goulburn Valley Health
Shepparton, Victoria, 3630
- Terminated
Gold Coast Hospital and Health Service- Gold Coast University Hospital
Southport, Queensland, 4215
- Recruiting
Royal North Shore Hospital
Sydney, New South Wales, 2035
- Recruiting
Westmead Hospital
Sydney, New South Wales, 2145
- Recruiting
St George Hospital
Sydney, New South Wales, 2217
- Withdrawn
Latrobe Regional Hospital
Traralgon, Victoria, 3844
- Recruiting
Princess Alexandra Hospital
Woolloongabba, Queensland, 4102
United Kingdom16 sites, 14 recruiting
- Recruiting
Belfast City Hospital
Belfast, BT9 7AB
- Recruiting
Southmead Hospital, North Bristol Trust
Bristol, BS10 5NB
- Terminated
Darlington Memorial Hospital
Darlington, DL3 6HX
- Recruiting
Russells Hall Hospital
Dudley, DY1 2HQ
- Recruiting
Royal Liverpool and Broadgreen Hospitals
Liverpool
- Recruiting
Whittington Hospital
London, N19 5NF
- Recruiting
Royal Marsden Hospital - London and Sutton
London
- Recruiting
Newcastle upon Tyne Hospitals
Newcastle upon Tyne
- Recruiting
Norfolk and Norwich University Hospital
Norwich, NR4 7UY
- Recruiting
Rotherham NHS Foundation Trust
Rotherham, S60 2UD
- Recruiting
Royal Hallamshire Hospital
Sheffield, S10 2JF
- Recruiting
University Hospital Southampton
Southampton
- Recruiting
St Helen's Hospital
St Helens, WA9 3DA
- Active, not recruiting
Torbay Hospital
Torquay, TQ2 7AA
- Recruiting
Royal Hampshire County Hospital
Winchester, SO22 5DG
- Recruiting
University Hospital Wishaw
Wishaw, Scotland
Hong Kong3 sites, 3 recruiting
- Recruiting
Pamela Youde Nethersole Eastern Hospital
Chai Wan
- Recruiting
North District Hospital
Shatin, Sha Tin
- Recruiting
Ruttonjee Hospital
Wan Chai
New Zealand3 sites, 3 recruiting
- Recruiting
Auckland City Hospital
Auckland, Auckland, 1023
- Recruiting
Middlemore Hospital
Auckland, Middlemore, 2025
- Recruiting
Waikato Hospital
Hamilton, Waikato Region, 3204
About this study
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.
Read the detailed description
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.
- Being tested
- lidocaine 2% and 10%, Placebo
- Keywords
- Anaesthesia, Local Anaesthesia, Chronic Post Surgical Pain
- Medical subject headings
- Breast Neoplasms, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lidocaine 2% and 10%Drug
Also called Xylocaine (lidocaine) 2% and Xylocard (lidocaine) 10%
Lidocaine infusion:
- 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).*
- Followed by a 2% lidocaine intravenous infusion for the duration of surgery, 0.1665 ml/kg/h of LBW (3.33 mg/kg/hr).*
- 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
PlaceboDrug
Also called 0.9% Saline solution
Placebo infusion:
- Commencing with an intravenous bolus after induction of anaesthesia, 0.125 ml/kg of lean body weight (LBW) of 0.9% Saline solution.*
- 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).*
- 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
| Study group | Role | What they receive |
|---|---|---|
| Lidocaine | Active comparator | 2% Lidocaine infusion intra-operative and 10% Lidocaine infusion post-operative. Receives: Drug: lidocaine 2% and 10% |
| Placebo | Placebo comparator | 0.9% Saline infusion intra-operative and 0.9% Saline infusion post-operative. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 1 year post-surgery
Secondary outcomes (18)
The incidence of severe CPSP at 1 year after surgery
NRS for worst pain the in the last week of ≥7)
Measured: 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)
Measured: 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)
Measured: 1 year post surgery
Physical functioning
Using interference component of mBPI-SF
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 1 year post surgery
Severity of acute postoperative pain at rest
Maximum pain score, Numerical rating scale (NRS) 0-10
Measured: 24 hours postoperatively
Severity of Acute postoperative pain on movement
Maximum pain score, Numerical rating scale (NRS) 0-10
Measured: 24 hours postoperatively
Postoperative opioid consumption
Morphine Equivalent Opioid Consumption (MEQ)
Measured: on Day 1
Postoperative opioid consumption
Morphine Equivalent Opioid Consumption (MEQ)
Measured: 3 months (last 24-hours)
Postoperative opioid consumption
Morphine Equivalent Opioid Consumption (MEQ)
Measured: 1 year post surgery (last 24 hours)
The incidence of mortality at 1 year
Mortality at 1 year
Measured: 1 year post surgery
UK NHS costs of care over 1 year following surgery
UK/NHS sites only
Measured: 1 year post surgery
Productivity costs over 1 year following surgery
UK/NHS sites only
Measured: 1 year post surgery
Quality-adjusted life years (QALYs) over 1 year following surgery
UK/NHS sites only
Measured: 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
Measured: 1 year post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2021
- Study start27 Jul 2022
- Primary completionMay 2028 (estimated)
- Study completionMay 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 4,300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Monash University
- Sponsor type
- University, hospital or other
- Collaborators
- Royal Perth Hospital
- Responsible party
- Principal investigator, Prof Tomas Corcoran, Monash University
- Investigators
- Tomas Corcoran, Principal investigator, Royal Perth Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05072314
- Sponsor's protocol ID
- HREC/74777/Alfred-2021
- Acronym
- LOLIPOP
- Status last verified
- Aug 2026
- First submitted
- 3 Oct 2021
- Last updated
- 12 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Toner AJ, Bailey MA, Schug SA, Corcoran TB. A pilot multicentre randomised controlled trial of lidocaine infusion in women undergoing breast cancer surgery. Anaesthesia. 2021 Oct;76(10):1326-1341. doi: 10.1111/anae.15440. Epub 2021 Mar 2.
PubMed 33651896Toner AJ, Bailey MA, Schug SA, Phillips M, Ungerer JP, Somogyi AA, Corcoran TB. Serum lidocaine (lignocaine) concentrations during prolonged perioperative infusion in patients undergoing breast cancer surgery: A secondary analysis of a randomised controlled trial. Anaesth Intensive Care. 2023 Nov;51(6):422-431. doi: 10.1177/0310057X231194833. Epub 2023 Oct 6.
PubMed 37802488