LOLIPOP

Overview

Moderate or severe Chronic Post-Surgical Pain (CPSP) is a significant problem with over a quarter of patients undergoing breast cancer surgery in the UK experiencing this complication. Perioperative lidocaine infusion is a promising intervention that may prevent the development of CPSP.

This study is funded by the National Institute for Health & Care Research Health Technology Assessment programme (project number NIHR159174).

Aims and objectives

LOLIPOP is a large-scale international randomised trial that aims to determine whether the administration of lidocaine by infusion during the intraoperative period and up to 24 hours following surgery (for overnight cases only) will decrease the incidence of moderate or severe Chronic Post-Surgical Pain (CPSP) detected at one year in patients undergoing elective primary surgical procedures for breast cancer.

The UK arm of the trial specifically aims to evaluate whether short-term infusions of lidocaine in the daycase setting is safe, effective and the intervention is cost-effective.

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 breast cancer under general anaesthesia (including those with simultaneous insertion of tissue expanders or implants).
• ·         American Society of Anaesthesiologist (ASA) physical scale 1-3

·        Exclusion criteria

• ·        Pre-existing pain at site of surgery, axilla, ipsilateral side of chest wall or the ipsilateral upper arm
• ·         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 1 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), including patients with known porphyria or methaemoglobinaemia
• ·         History of epilepsy
• ·        Baseline heart rate <50 bpm or systolic blood pressure <100mmHg
• ·        Acute coronary event in the last 3 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)
• ·        Abnormal serum sodium concentration (based upon site laboratory reference ranges)
• ·         Active liver disease
• ·        Medications within the last 7 days which are known/suspected to slow lidocaine metabolism (amiodarone, beta blockers, cimetidine, fluoroquinolones, fluvoxamine, imidazole’s, macrolides, verapamil, HIV drugs)
• ·         Cardiac Failure
• ·        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)

Planned sample size
4300 participants internationally, of which 1000 will be from the UK

Total number of sites planned
A minimum of 10 UK sites

Timeline

Recruiting until July 2027, with a 12 month internal pilot.

There will be a 1-year follow-up therefore study end date is estimated as being July 2028.