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

Inclusion Criteria:

• Consenting adult female patients (≥18 years) undergoing mastectomy (unilateral orbilateral) or breast conserving surgery (unilateral or bilateral) for the primaryexcision 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 theipsilateral upper arm

• Re-excision procedures where the margins at the index surgery have been deemedinsufficient

• When immediate autologous reconstruction surgery is planned

• Where delayed autologous reconstruction surgery on the operative breast within oneyear 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 otheramide local anaesthetic agents e.g. other amide local anaesthetic agents:ropivacaine, bupivacaine, mepivacaine, prilocaine, etidocaine), including patientswith 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 (alldegrees), Bundle Branch Block or Fascicular block, Prolonged QT interval, WolfParkinson White syndrome, channelopathy such as Brugada syndrome. A preoperativeElectrocardiogram (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-alcoholicfatty liver disease, haemochromatosis, other rarer causes)

• Medications within the last 7 days which are known / suspected to slow lidocainemetabolism (amiodarone, beta blockers, cimetidine, fluoroquinolones, fluvoxamine,imidazoles, macrolides, verapamil, HIV drugs)

• Cardiac Failure (any documented heart failure at peroperative assessment or GPrecords)

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

• Co-administration of lidocaine within 24 hours prior to surgery for other reasons (e.g. lidocaine patches