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Looking for participantsPhase3

Long-term Outcomes of Lidocaine Infusions for Post-Operative Pain (LOLIPOP) Trial

Sponsor: Monash University

NCT ID: NCT05072314

View on ClinicalTrials.gov ↗

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.

Breast CancerBreast Cancer FemaleBreast Conserving SurgeryMastectomy

How this trial compares with your answers

Answer 2 more questions to improve match

What we know so far

Condition· Matched your search
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Gender· Tell us your sex for better matching

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
Inclusion Criteria: * 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 Exclusion Criteria: * 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 * 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

Where Is This Study? (16 UK sites)

University Hospital Wishaw

Wishaw, United Kingdom

Recruiting

Belfast City Hospital

Belfast BT9 7AB, United Kingdom

Recruiting

Southmead Hospital, North Bristol Trust

Bristol BS10 5NB, United Kingdom

Recruiting
Hospital R&D contact (matched)

Helen Lewis-White

Research@nbt.nhs.uk0117 41 49330

Darlington Memorial Hospital

Darlington DL3 6HX, United Kingdom

TERMINATED
Hospital R&D contact (matched)

Research and Development Team cdda-tr.Research@nhs.net

nencadmin@nihr.ac.uk01325 743366

Russells Hall Hospital

Dudley DY1 2HQ, United Kingdom

Recruiting
Hospital R&D contact (matched)

Claire Phillips

dgft.research.rhh@nhs.net01384 456111

Royal Liverpool and Broadgreen Hospitals

Liverpool, United Kingdom

Recruiting

Whittington Hospital

London N19 5NF, United Kingdom

Recruiting
Hospital R&D contact (matched)

Research Support Team

whh-tr.researchsupport@nhs.net0207 288 3585

Royal Marsden Hospital - London and Sutton

London, United Kingdom

Recruiting
Hospital R&D contact (matched)

Mark Brandon-Grove

research.development@rmh.nhs.uk020 3186 5416

Newcastle upon Tyne Hospitals

Newcastle upon Tyne, United Kingdom

Recruiting
Hospital R&D contact (matched)

Research and Development

nuth.genericqueries@nhs.net0191 282 4926

Norfolk and Norwich University Hospital

Norwich NR4 7UY, United Kingdom

Recruiting
Hospital R&D contact (matched)

Julie Dawson

rdsubmissions@nnuh.nhs.uk01603 286611

Rotherham NHS Foundation Trust

Rotherham S60 2UD, United Kingdom

Recruiting
Hospital R&D contact (matched)

Rachel Walker

rgh-tr.researchanddevelopment@nhs.net01709 426066

Royal Hallamshire Hospital

Sheffield S10 2JF, United Kingdom

Recruiting
Hospital R&D contact (matched)

Alessia Dunn

STH.ResearchAdministration@nhs.net0114 2712550

University Hospital Southampton

Southampton, United Kingdom

Recruiting
Hospital R&D contact (matched)

Dr Mikayala King

researchmanagement@uhs.nhs.uk023 81208215

St Helen's Hospital

St Helens WA9 3DA, United Kingdom

Recruiting

Torbay Hospital

Torquay TQ2 7AA, United Kingdom

ACTIVE_NOT_RECRUITING
Hospital R&D contact (matched)

Dr Fiona Roberts (R&D Director)

tsdft.research@nhs.net01803 656635

Royal Hampshire County Hospital

Winchester SO22 5DG, United Kingdom

Recruiting
Hospital R&D contact (matched)

Research Manager

research.team@hhft.nhs.uk01256 473202 Ext 4557

How to Get in Touch

Gillian Ormond

Sponsor contact

CONTACT

+610399030387 gillian.ormond@monash.edu

Natalie Hird

Sponsor contact

CONTACT

+61 (0) 459 407 231 natalie.hird@health.wa.gov.au
Data sourced from ClinicalTrials.gov · Last verified: 2026-08