Long-term Outcomes of Lidocaine Infusions for Post-Operative Pain (LOLIPOP) 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.
Study details:
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.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
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).
- 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
Eligibility
Age eligible for study : NA
Healthy volunteers accepted : No
Gender eligible for study: FEMALE
Things to know
Study dates
Study start:
Primary completion:
Study completion finish:
Study type
PREVENTION
Phase
- PHASE3
Study ID
NCT05072314
Intervention or treatment
DRUG: lidocaine 2% and 10%
DRUG: Placebo
Conditions
- Breast Cancer
- Breast Cancer Female
- Breast Conserving Surgery
- Mastectomy
You may be eligible to participate in this trial based on your search. Check eligibility by answering some questions.
Research sites nearby
Closest Location:
Blacktown Mount Druitt Hospital
Select from list below to view details:
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
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Who is running the clinical trial?
Monash University
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
| Participant Group/Arm | Intervention/Treatment |
|---|---|
ACTIVE_COMPARATOR: Lidocaine
| Drug: lidocaine 2% and 10% |
PLACEBO_COMPARATOR: Placebo
| Drug: Placebo |
What is the study measuring?
Primary Outcome
| Measure | Description | Time Frame |
|---|---|---|
| The incidence of moderate or severe CPSP at 1 year after surgery, as reported by the patient at the follow-up review. | 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). | 1 year post-surgery |
Secondary Outcome
| Measure | Description | Time Frame |
|---|---|---|
| The incidence of severe CPSP at 1 year after surgery | NRS for worst pain the in the last week of ≥7) | 1 year post surgery |
| Severity of pain at the site of 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) | 1 year post surgery |
| Incidence of neuropathic symptoms | Incidence examined as a binary outcome using the Short Form of Douleur Neuropathique 4 Questions (S-DN4) | 1 year post surgery |
| Physical functioning | Using interference component of mBPI-SF | 1 year post surgery |
| Changes in quality of life metrics EuroQol 5 Dimension 5 Level (EQ-5D-5L) at 1 year after surgery compared to baseline | Changes in the quality of life | 1 year post surgery |
| Changes in psychological wellbeing Kessler Psychological Distress Scale (K-10) at 1 year after surgery compared to baseline. | Changes in psychological wellbeing | 1 year post surgery |
| The incidence of mild or greater pain at the site of surgery at 1 year after surgery | NRS for worst pain the in the last week of ≥1 | 1 year post surgery |
| The incidence of discomfort or altered sensation at the site of surgery (not reported as pain) | Patients asked if they have any altered sensation at the site of surgery | 1 year post surgery |
| Severity of acute postoperative pain at rest | Maximum pain score, Numerical rating scale (NRS) 0-10 | 24 hours postoperatively |
| Severity of Acute postoperative pain on movement | Maximum pain score, Numerical rating scale (NRS) 0-10 | 24 hours postoperatively |
| Postoperative opioid consumption | Morphine Equivalent Opioid Consumption (MEQ) | on Day 1 |
| Postoperative opioid consumption | Morphine Equivalent Opioid Consumption (MEQ) | 3 months (last 24-hours) |
| Postoperative opioid consumption | Morphine Equivalent Opioid Consumption (MEQ) | 1 year post surgery (last 24 hours) |
| The incidence of mortality at 1 year | Mortality at 1 year | 1 year post surgery |
| UK NHS costs of care over 1 year following surgery | UK/NHS sites only | 1 year post surgery |
| Productivity costs over 1 year following surgery | UK/NHS sites only | 1 year post surgery |
| Quality-adjusted life years (QALYs) over 1 year following surgery | UK/NHS sites only | 1 year post surgery |
| Cost-effectiveness of perioperative lidocaine infusions compared to usual care, from a primary UK NHS perspective and broader perspective including productivity, at 1 year. | UK/NHS sites only | 1 year post surgery |
References
Clinical Trials Gov: Long-term Outcomes of Lidocaine Infusions for Post-Operative Pain (LOLIPOP) TrialOther trials to consider
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