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Evaluating lidocaine infusions for managing post-operative pain in breast cancer surgery

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

Phase 3 Interventional Monash University · NCT05072314

This study is testing if giving lidocaine infusions during and after breast cancer surgery can help women avoid long-lasting pain after their operation.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment4300 (estimated)
Ages18 Years and up
SexFemale
SponsorMonash University Academic / other
Locations47 sites (Kingswood, New South Wales and 46 other locations)
Trial IDNCT05072314 on ClinicalTrials.gov

What this trial studies

The LOLIPOP Trial is a large, international, multicentre clinical trial designed to assess the effectiveness of lidocaine infusions administered during and after elective breast cancer surgeries. It involves a randomized, double-blind, placebo-controlled approach with a target enrollment of 4,300 female patients. The primary goal is to determine if lidocaine can significantly reduce the incidence of chronic post-surgical pain one year after surgery. Secondary outcomes will evaluate safety, pain management efficacy, and quality of life metrics.

Who should consider this trial

Good fit: Ideal candidates are adult female patients aged 18 and older undergoing mastectomy or breast-conserving surgery for breast cancer.

Not a fit: Patients with pre-existing pain at the surgical site or those requiring immediate or delayed autologous reconstruction may not benefit from this study.

Why it matters

Potential benefit: If successful, this trial could lead to improved pain management strategies for women undergoing breast cancer surgery, potentially reducing the incidence of chronic pain.

How similar studies have performed: Previous studies have shown promising results with lidocaine infusions for pain management, suggesting potential for success in this approach.

Eligibility criteria

Show full inclusion / exclusion 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 this trial is running

Kingswood, New South Wales and 46 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Breast CancerBreast Cancer FemaleBreast Conserving SurgeryMastectomyAnaesthesiaLocal AnaesthesiaChronic Post Surgical Pain
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.