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

NCT05072314 | Recruiting Phase 3 DMC

• 1 other identifier: HREC/74777/Alfred-2021
• Study Type: interventional
• Target: 4,300
• Locations: 4 countries
• Sites: 47

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.

Conditions

Breast Cancer; Breast Cancer Female; Breast Conserving Surgery; Mastectomy

Keywords

Anaesthesia; Local Anaesthesia; Chronic Post Surgical Pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (18)

• The incidence of severe CPSP at 1 year after surgery

  1 year post surgery

• Severity of pain at the site of surgery

  1 year post surgery

• Incidence of neuropathic symptoms

  1 year post surgery

• Physical functioning

  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

  1 year post surgery

Other Outcomes (13)

• Incidence of treated bradycardia intraoperatively

  24 hours postoperatively

• Incidence of treated hypotension intraoperatively

  24 hours postoperatively

• Incidence of treated bradycardia in Post Anaesthesia Care Unit (PACU)

  24 hours postoperatively

Study Arms (2)

Lidocaine

ACTIVE COMPARATOR

2% Lidocaine infusion intra-operative and 10% Lidocaine infusion post-operative.

Drug: lidocaine 2% and 10%

Placebo

PLACEBO COMPARATOR

0.9% Saline infusion intra-operative and 0.9% Saline infusion post-operative.

Drug: Placebo

Interventions

lidocaine 2% and 10% DRUG

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

Also known as: Xylocaine (lidocaine) 2% and Xylocard (lidocaine) 10%

Lidocaine

Placebo DRUG

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

Also known as: 0.9% Saline solution

Placebo

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Monash University: lead
• Royal Perth Hospital: collaborator

Study Sites (47)

Nepean Hospital

Kingswood, New South Wales, 2747, Australia

RECRUITING

Blacktown Mount Druitt Hospital

Mount Druitt, New South Wales, 2770, Australia

RECRUITING

Royal North Shore Hospital

Sydney, New South Wales, 2035, Australia

RECRUITING

Westmead Hospital

Sydney, New South Wales, 2145, Australia

RECRUITING

St George Hospital

Sydney, New South Wales, 2217, Australia

RECRUITING

Royal Brisbane and Women's Hospital

Brisbane, Queensland, 4029, Australia

RECRUITING

Queen Elizabeth II Jubilee Hospital

Coopers Plains, Queensland, 4108, Australia

RECRUITING

Mackay Base Hospital

Mackay, Queensland, 4740, Australia

RECRUITING

Rockhampton Hospital

Rockhampton, Queensland, 4700, Australia

TERMINATED

Gold Coast Hospital and Health Service- Gold Coast University Hospital

Southport, Queensland, 4215, Australia

TERMINATED

Princess Alexandra Hospital

Woolloongabba, Queensland, 4102, Australia

RECRUITING

Flinders Medical Centre

Bedford Park, South Australia, 5042, Australia

RECRUITING

Royal Hobart Hospital

Hobart, Tasmania, 7000, Australia

RECRUITING

Anaesthetic Group Ballarat

Ballarat, Victoria, 3350, Australia

TERMINATED

Ballarat Health Services (Grampians Health)

Ballarat, Victoria, 3350, Australia

RECRUITING

Barwon Health - University Hospital Geelong

Geelong, Victoria, 3220, Australia

RECRUITING

The Alfred

Melbourne, Victoria, 3004, Australia

RECRUITING

Royal Melbourne Hospital

Melbourne, Victoria, 3050, Australia

RECRUITING

St Vincent's Hospital Melbourne

Melbourne, Victoria, 3065, Australia

RECRUITING

Northern Hospital

Melbourne, Victoria, 3076, Australia

WITHDRAWN

Monash Health - Moorabbin Hospital

Melbourne, Victoria, 3165, Australia

COMPLETED

Maroondah Hospital - Eastern Health

Ringwood East, Victoria, 3135, Australia

RECRUITING

Goulburn Valley Health

Shepparton, Victoria, 3630, Australia

TERMINATED

Latrobe Regional Hospital

Traralgon, Victoria, 3844, Australia

WITHDRAWN

Royal Perth Hospital

Perth, Western Australia, 6000, Australia

RECRUITING

St John of God Subiaco

Perth, Western Australia, 6008, Australia

RECRUITING

North District Hospital

Shatin, Sha Tin, Hong Kong

RECRUITING

Pamela Youde Nethersole Eastern Hospital

Chai Wan, Hong Kong

RECRUITING

Ruttonjee Hospital

Wan Chai, Hong Kong

RECRUITING

Auckland City Hospital

Auckland, Auckland, 1023, New Zealand

RECRUITING

Middlemore Hospital

Auckland, Middlemore, 2025, New Zealand

RECRUITING

Waikato Hospital

Hamilton, Waikato Region, 3204, New Zealand

RECRUITING

University Hospital Wishaw

Wishaw, Scotland, United Kingdom

RECRUITING

Belfast City Hospital

Belfast, BT9 7AB, United Kingdom

RECRUITING

Southmead Hospital, North Bristol Trust

Bristol, BS10 5NB, United Kingdom

RECRUITING

Darlington Memorial Hospital

Darlington, DL3 6HX, United Kingdom

COMPLETED

Russells Hall Hospital

Dudley, DY1 2HQ, United Kingdom

RECRUITING

Royal Liverpool and Broadgreen Hospitals

Liverpool, United Kingdom

RECRUITING

Whittington Hospital

London, N19 5NF, United Kingdom

RECRUITING

Royal Marsden Hospital - London and Sutton

London, United Kingdom

RECRUITING

Newcastle upon Tyne Hospitals

Newcastle upon Tyne, United Kingdom

RECRUITING

Norfolk and Norwich University Hospital

Norwich, NR4 7UY, United Kingdom

RECRUITING

Rotherham NHS Foundation Trust

Rotherham, S60 2UD, United Kingdom

RECRUITING

Royal Hallamshire Hospital

Sheffield, S10 2JF, United Kingdom

RECRUITING

University Hospital Southampton

Southampton, United Kingdom

RECRUITING

St Helen's Hospital

St Helens, WA9 3DA, United Kingdom

RECRUITING

Torbay Hospital

Torquay, TQ2 7AA, United Kingdom

ACTIVE NOT RECRUITING

Related Publications (2)

• Toner AJ, Bailey MA, Schug SA, Corcoran TB. A pilot multicentre randomised controlled trial of lidocaine infusion in women undergoing breast cancer surgery. Anaesthesia. 2021 Oct;76(10):1326-1341. doi: 10.1111/anae.15440. Epub 2021 Mar 2.

  PMID: 33651896 BACKGROUND

• Toner AJ, Bailey MA, Schug SA, Phillips M, Ungerer JP, Somogyi AA, Corcoran TB. Serum lidocaine (lignocaine) concentrations during prolonged perioperative infusion in patients undergoing breast cancer surgery: A secondary analysis of a randomised controlled trial. Anaesth Intensive Care. 2023 Nov;51(6):422-431. doi: 10.1177/0310057X231194833. Epub 2023 Oct 6.

  PMID: 37802488 BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms; Pain, Postoperative

Interventions

Lidocaine; Saline Solution

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Tomas Corcoran

  Royal Perth Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gillian Ormond

CONTACT

+610399030387; gillian.ormond@monash.edu

Natalie Hird

CONTACT

+61 (0) 459 407 231; natalie.hird@health.wa.gov.au

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: All trial participants, research coordinators, members of the anaesthesia and surgical teams, pharmacists, theatre and ward staff and all individuals performing patient follow up will be blinded to the patient's treatment allocation. All of the trial committees associated with the study will be blinded, with the exception of the Data Safety and Monitoring Committee (DSMC), who will receive unblinded (open) reports from the independent statistician. Unblinding of the patient's treatment allocation will be possible in exceptional circumstances, and a process will be in place to facilitate unblinding requests.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Principal Investigator

Study Record Dates

• First Submitted: October 3, 2021
• First Posted: October 8, 2021
• Study Start: July 27, 2022
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2028
• Last Updated: March 25, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

HK (3); AU (26); GB (15); NZ (3)