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Clinical Trials in Australia / NCT05072314
Recruiting Phase 3

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

NCT05072314 · tracked via the Priya Life Science Australia tracker
Phase
Phase 3
Started
2022-07-27
Last updated
2026-08-12

Condition(s) studied

Breast CancerBreast Cancer FemaleBreast Conserving SurgeryMastectomy

Investigational drug(s) / intervention(s)

lidocaine 2% and 10% →Placebo

lidocaine 2% and 10%: Lidocaine infusion: 1. Commencing with an intravenous bolus after induction of anaesthesia, 0.125 ml/kg of lean body weight (LBW) of 2% lidocaine (2.5 mg/kg).\* 2. Followed by a 2% lidocaine intravenous infusion for the duration of surgery, 0.1665 ml/kg/h of LBW (3.33 mg/kg/hr).\* 3. A post-operative subcutaneous 0.0222 ml/kg/hr of LBW 10% lidocaine infusion for up to 24 hours thereafter (2.22 mg/kg/hr). Dosage will be capped at a maximum lean body weight of 68kg. * \*Day-case surgery receives intraoperative bolus and intraoperative infusion only

Placebo: Placebo infusion: 1. Commencing with an intravenous bolus after induction of anaesthesia, 0.125 ml/kg of lean body weight (LBW) of 0.9% Saline solution.\* 2. Followed by a 0.9% Saline solution intravenous infusion for the duration of surgery, 0.1665 ml/kg/h of LBW (3.33 mg/kg/hr).\* 3. A post-operative subcutaneous 0.0222 ml/kg/hr of LBW 0.9% Saline solution infusion for up to 24 hours thereafter (2.22 mg/kg/hr). Dosage will be capped at a maximum lean body weight of 68kg. * \*Day-case surgery receives intraoperative bolus and intraoperative infusion only

Study 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.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (49)

FacilityCityRegionStatus
Nepean Hospital Kingswood New South Wales Recruiting
Blacktown Mount Druitt Hospital Mount Druitt New South Wales Recruiting
Royal North Shore Hospital Sydney New South Wales Recruiting
Westmead Hospital Sydney New South Wales Recruiting
St George Hospital Sydney New South Wales Recruiting
Royal Brisbane and Women's Hospital Brisbane Queensland Terminated
Queen Elizabeth II Jubilee Hospital Coopers Plains Queensland Recruiting
Mackay Base Hospital Mackay Queensland Recruiting
Rockhampton Hospital Rockhampton Queensland Terminated
Gold Coast Hospital and Health Service- Gold Coast University Hospital Southport Queensland Terminated
Princess Alexandra Hospital Woolloongabba Queensland Recruiting
Flinders Medical Centre Bedford Park South Australia Recruiting
Royal Hobart Hospital Hobart Tasmania Recruiting
Anaesthetic Group Ballarat Ballarat Victoria Terminated
Ballarat Health Services (Grampians Health) Ballarat Victoria Recruiting
Barwon Health - University Hospital Geelong Geelong Victoria Recruiting
The Alfred Melbourne Victoria Recruiting
Royal Melbourne Hospital Melbourne Victoria Recruiting
St Vincent's Hospital Melbourne Melbourne Victoria Recruiting
Northern Hospital Melbourne Victoria Withdrawn
Monash Health - Moorabbin Hospital Melbourne Victoria Terminated
Maroondah Hospital - Eastern Health Ringwood East Victoria Recruiting
Goulburn Valley Health Shepparton Victoria Terminated
Latrobe Regional Hospital Traralgon Victoria Withdrawn
Bentley Health Service Bentley Western Australia Recruiting
Royal Perth Hospital Perth Western Australia Recruiting
St John of God Subiaco Perth Western Australia Recruiting
North District Hospital Shatin Sha Tin Recruiting
Pamela Youde Nethersole Eastern Hospital Chai Wan Hong Kong Recruiting
Ruttonjee Hospital Wan Chai Hong Kong Recruiting
Auckland City Hospital Auckland Auckland Recruiting
Middlemore Hospital Auckland Middlemore Recruiting
Waikato Hospital Hamilton Waikato Region Recruiting
University Hospital Wishaw Wishaw Scotland Recruiting
Belfast City Hospital Belfast United Kingdom Recruiting
Southmead Hospital, North Bristol Trust Bristol United Kingdom Recruiting
Darlington Memorial Hospital Darlington United Kingdom Terminated
Russells Hall Hospital Dudley United Kingdom Recruiting
Royal Liverpool and Broadgreen Hospitals Liverpool United Kingdom Recruiting
Whittington Hospital London United Kingdom Recruiting

+ 9 more sites — see the full list on the official registry below.

More Monash University trials in Australia

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05072314 on ClinicalTrials.gov ↗ ← All trials in Australia