Long-term Outcomes of Lidocaine Infusions for Post-Operative Pain (LOLIPOP) Trial
- Conditions
- Breast CancerBreast Cancer FemaleBreast Conserving SurgeryMastectomy
- Interventions
- Drug: Placebo
- Registration Number
- NCT05072314
- Lead Sponsor
- Monash University
- Brief 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.
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 4300
- 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
- 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 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)
- Abnormal serum sodium 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Lidocaine lidocaine 2% and 10% 2% Lidocaine infusion intra-operative and 10% Lidocaine infusion post-operative. Placebo Placebo 0.9% Saline infusion intra-operative and 0.9% Saline infusion post-operative.
- Primary Outcome Measures
Name Time Method The incidence of moderate or severe CPSP at 1 year after surgery, as reported by the patient at the follow-up review. 1 year post-surgery 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).
- Secondary Outcome Measures
Name Time Method Severity of acute postoperative pain at rest 24 hours postoperatively Maximum pain score, Numerical rating scale (NRS) 0-10
Severity of Acute postoperative pain on movement 24 hours postoperatively Maximum pain score, Numerical rating scale (NRS) 0-10
Postoperative opioid consumption 1 year post surgery (last 24 hours) Morphine Equivalent Opioid Consumption (MEQ)
The Incidence of moderate to severe Chronic Post Surgical Pain from radiation therapy 1 year post surgery with a significant contribution from radiation therapy
The Incidence of moderate to severe Chronic Post Surgical Pain from repeat surgery 1 year post surgery with a significant contribution from repeat surgery
The incidence of severe CPSP at 1 year after surgery 1 year post surgery NRS for worst pain the in the last week of ≥7)
The incidence of mild or greater CPSP at 1 year after surgery 1 year post surgery NRS for worst pain the in the last week of ≥1
The incidence of discomfort or altered sensation at the site of surgery (not reported as pain) 1 year post surgery Patients asked if they have any altered sensation at the site of surgery
Severity of CPSP 1 year post 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)
Incidence of neuropathic symptoms 1 year post surgery Incidence examined as a binary outcome using the Short Form of Douleur Neuropathique 4 Questions (S-DN4)
Physical functioning 1 year post surgery Using interference component of mBPI-SF
Changes in quality of life metrics EuroQol 5 Dimension 5 Level (EQ-5D-5L) at 1 year after surgery compared to baseline 1 year post surgery Changes in the quality of life
Changes in psychological wellbeing Kessler Psychological Distress Scale (K-10) at 1 year after surgery compared to baseline. 1 year post surgery Changes in psychological wellbeing
The incidence of mortality at 1 year 1 year post surgery Mortality at 1 year
UK NHS costs of care over 1 year following surgery 1 year post surgery UK/NHS sites only
Productivity costs over 1 year following surgery 1 year post surgery UK/NHS sites only
Quality-adjusted life years (QALYs) over 1 year following surgery 1 year post surgery UK/NHS sites only
Cost-effectiveness of perioperative lidocaine infusions compared to usual care, from a primary UK NHS perspective and broader perspective including productivity, at 1 year. 1 year post surgery UK/NHS sites only
Trial Locations
- Locations (37)
Blacktown Mount Druitt Hospital
🇦🇺Blacktown/Mt 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
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
Royal Perth Hospital
🇦🇺Perth, Western Australia, Australia
St John of God Subiaco
🇦🇺Perth, Western Australia, Australia
Pamela Youde Nethersole Eastern Hospital
🇭🇰Chai Wan, Hong Kong
North District Hospital
🇭🇰Sha Tin, Hong Kong
Ruttonjee Hospital
🇭🇰Wan Chai, Hong Kong
Middlemore Hospital
🇳🇿Auckland, Middlemore, New Zealand
Waikato Hospital
🇳🇿Hamilton, Waikato, New Zealand
Auckland City Hospital
🇳🇿Auckland, New Zealand
University Hospital Wishaw
🇬🇧Wishaw, Scotland, United Kingdom
Southmead Hospital, North Bristol Trust
🇬🇧Bristol, United Kingdom
Darlington Memorial Hospital
🇬🇧Darlington, United Kingdom
Royal Liverpool and Broadgreen Hospitals
🇬🇧Liverpool, United Kingdom
Rotherham NHS Foundation Trust
🇬🇧Rotherham, United Kingdom
University Hospital Southampton
🇬🇧Southampton, United Kingdom