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

• Status: Not yet recruiting
• Trial end date: 2028-02-01
• Target enrollment: 0
• Participant gender: Female

Summary

The LOLIPOP Trial is a large (n=4,300 patients) pragmatic, international, multicentre, prospective, randomised, double blind, placebo-controlled, parallel assessment, stratified safety and effectiveness superiority study.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Monash University
• Collaborator: Royal Perth Hospital
• Treatments: Lidocaine

Criteria

Inclusion Criteria:

• Consenting adult female patients (≥18 years, <80 years) undergoing mastectomy or breast conserving surgery 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 one year is planned or deemed likely

• Planned use of regional analgesia infusions

• Inability to communicate in English

• Impaired cognition

• Pregnant or lactating females

• Known metastatic disease

• 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; 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.

• 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)

• Abnormal liver function tests (based upon site laboratory reference ranges)

• 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

• Severe Renal Failure (Creatinine Clearance of less than 30ml/min or dialysis dependent)