Long-term Outcomes of Lidocaine Infusions for Post-Operative Pain (LOLIPOP) Trial
Recruiting · NCT05072314 · Interventional (participants receive a specific treatment) · Lead sponsor: Monash University
View the official record on ClinicalTrials.gov →Interventions studied
Placebolidocaine 2% and 10%
What this trial is about
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
Age range
18 Years and older
Sex
Female
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
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 it is running
49 locations listed.
- Belfast City Hospital - Belfast, United Kingdom
- Southmead Hospital, North Bristol Trust - Bristol, United Kingdom
- Pamela Youde Nethersole Eastern Hospital - Chai Wan, Hong Kong
- Darlington Memorial Hospital - Darlington, United Kingdom
- Russells Hall Hospital - Dudley, United Kingdom
- Royal Liverpool and Broadgreen Hospitals - Liverpool, United Kingdom
- Whittington Hospital - London, United Kingdom
- Royal Marsden Hospital - London and Sutton - London, United Kingdom
- Newcastle upon Tyne Hospitals - Newcastle upon Tyne, United Kingdom
- Norfolk and Norwich University Hospital - Norwich, United Kingdom
- Rotherham NHS Foundation Trust - Rotherham, United Kingdom
- Royal Hallamshire Hospital - Sheffield, United Kingdom
- University Hospital Southampton - Southampton, United Kingdom
- St Helen's Hospital - St Helens, United Kingdom
- Torbay Hospital - Torquay, United Kingdom
- Ruttonjee Hospital - Wan Chai, Hong Kong
- Royal Hampshire County Hospital - Winchester, United Kingdom
- Auckland City Hospital - Auckland, Auckland, New Zealand
- Middlemore Hospital - Auckland, Middlemore, New Zealand
- Nepean Hospital - Kingswood, New South Wales, Australia
- Blacktown Mount Druitt Hospital - Mount Druitt, New South Wales, Australia
- Royal North Shore Hospital - Sydney, New South Wales, Australia
- Westmead Hospital - Sydney, New South Wales, Australia
- St George Hospital - Sydney, New South Wales, Australia
- Royal Brisbane and Women's Hospital - Brisbane, Queensland, Australia
- Queen Elizabeth II Jubilee Hospital - Coopers Plains, Queensland, Australia
- Mackay Base Hospital - Mackay, Queensland, Australia
- Rockhampton Hospital - Rockhampton, Queensland, Australia
- Gold Coast Hospital and Health Service- Gold Coast University Hospital - Southport, Queensland, Australia
- Princess Alexandra Hospital - Woolloongabba, Queensland, Australia
- University Hospital Wishaw - Wishaw, Scotland, United Kingdom
- North District Hospital - Shatin, Sha Tin, Hong Kong
- Flinders Medical Centre - Bedford Park, South Australia, Australia
- Royal Hobart Hospital - Hobart, Tasmania, Australia
- Anaesthetic Group Ballarat - Ballarat, Victoria, Australia
- Ballarat Health Services (Grampians Health) - Ballarat, Victoria, Australia
- Barwon Health - University Hospital Geelong - Geelong, Victoria, Australia
- The Alfred - Melbourne, Victoria, Australia
- Royal Melbourne Hospital - Melbourne, Victoria, Australia
- St Vincent's Hospital Melbourne - Melbourne, Victoria, Australia
- Northern Hospital - Melbourne, Victoria, Australia
- Monash Health - Moorabbin Hospital - Melbourne, Victoria, Australia
- Maroondah Hospital - Eastern Health - Ringwood East, Victoria, Australia
- Goulburn Valley Health - Shepparton, Victoria, Australia
- Latrobe Regional Hospital - Traralgon, Victoria, Australia
- Waikato Hospital - Hamilton, Waikato Region, New Zealand
- Bentley Health Service - Bentley, Western Australia, Australia
- Royal Perth Hospital - Perth, Western Australia, Australia
- St John of God Subiaco - Perth, Western Australia, Australia