Actively Recruiting

Phase 3
Age: 18Years +
FEMALE
NCT05072314

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

Led by Monash University · Updated on 2026-03-25

4300

Participants Needed

47

Research Sites

309 weeks

Total Duration

On this page

Sponsors

M

Monash University

Lead Sponsor

R

Royal Perth Hospital

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Female patients aged 18 years or older
  • Undergoing mastectomy (unilateral or bilateral) or breast conserving surgery (unilateral or bilateral) for confirmed or suspected primary breast cancer
  • Surgery performed under general anaesthesia
  • American Society of Anaesthesiologist (ASA) physical status 1 to 3
  • Includes those with simultaneous insertion of tissue expanders or implants
  • Excludes surgery for locoregional recurrence of breast cancer
Not Eligible

You will not qualify if you...

  • Breast surgery combined with additional procedures like laparoscopic salpingectomy
  • Surgery for locoregional recurrence of breast cancer
  • Pre-existing pain at the surgery site, axilla, chest wall, or upper arm on the side of surgery before tumor procedures
  • Re-excision due to insufficient margins at initial surgery
  • Planned immediate or delayed autologous reconstruction within one year
  • Planned use of regional analgesia infusions
  • Impaired cognition
  • Pregnant or lactating females
  • Transgender patients
  • Known metastatic breast cancer
  • History of allergy or contraindication to lidocaine or similar local anesthetics
  • History of epilepsy
  • Baseline heart rate under 50 bpm or systolic blood pressure under 100 mmHg
  • Recent acute coronary event within three months
  • Certain cardiac conduction abnormalities
  • Abnormal serum potassium levels
  • Active liver disease
  • Use of medications in the past 7 days that slow lidocaine metabolism
  • Documented heart failure
  • Severe renal failure or dialysis dependency
  • Lidocaine use within 24 hours before surgery for other reasons

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 47 locations

1

Nepean Hospital

Kingswood, New South Wales, Australia, 2747

Actively Recruiting

2

Blacktown Mount Druitt Hospital

Mount Druitt, New South Wales, Australia, 2770

Actively Recruiting

3

Royal North Shore Hospital

Sydney, New South Wales, Australia, 2035

Actively Recruiting

4

Westmead Hospital

Sydney, New South Wales, Australia, 2145

Actively Recruiting

5

St George Hospital

Sydney, New South Wales, Australia, 2217

Actively Recruiting

6

Royal Brisbane and Women's Hospital

Brisbane, Queensland, Australia, 4029

Actively Recruiting

7

Queen Elizabeth II Jubilee Hospital

Coopers Plains, Queensland, Australia, 4108

Actively Recruiting

8

Mackay Base Hospital

Mackay, Queensland, Australia, 4740

Actively Recruiting

9

Rockhampton Hospital

Rockhampton, Queensland, Australia, 4700

Terminated

10

Gold Coast Hospital and Health Service- Gold Coast University Hospital

Southport, Queensland, Australia, 4215

Terminated

11

Princess Alexandra Hospital

Woolloongabba, Queensland, Australia, 4102

Actively Recruiting

12

Flinders Medical Centre

Bedford Park, South Australia, Australia, 5042

Actively Recruiting

13

Royal Hobart Hospital

Hobart, Tasmania, Australia, 7000

Actively Recruiting

14

Anaesthetic Group Ballarat

Ballarat, Victoria, Australia, 3350

Terminated

15

Ballarat Health Services (Grampians Health)

Ballarat, Victoria, Australia, 3350

Actively Recruiting

16

Barwon Health - University Hospital Geelong

Geelong, Victoria, Australia, 3220

Actively Recruiting

17

The Alfred

Melbourne, Victoria, Australia, 3004

Actively Recruiting

18

Royal Melbourne Hospital

Melbourne, Victoria, Australia, 3050

Actively Recruiting

19

St Vincent's Hospital Melbourne

Melbourne, Victoria, Australia, 3065

Actively Recruiting

20

Northern Hospital

Melbourne, Victoria, Australia, 3076

Withdrawn

21

Monash Health - Moorabbin Hospital

Melbourne, Victoria, Australia, 3165

Completed

22

Maroondah Hospital - Eastern Health

Ringwood East, Victoria, Australia, 3135

Actively Recruiting

23

Goulburn Valley Health

Shepparton, Victoria, Australia, 3630

Terminated

24

Latrobe Regional Hospital

Traralgon, Victoria, Australia, 3844

Withdrawn

25

Royal Perth Hospital

Perth, Western Australia, Australia, 6000

Actively Recruiting

26

St John of God Subiaco

Perth, Western Australia, Australia, 6008

Actively Recruiting

27

North District Hospital

Shatin, Sha Tin, Hong Kong

Actively Recruiting

28

Pamela Youde Nethersole Eastern Hospital

Chai Wan, Hong Kong

Actively Recruiting

29

Ruttonjee Hospital

Wan Chai, Hong Kong

Actively Recruiting

30

Auckland City Hospital

Auckland, Auckland, New Zealand, 1023

Actively Recruiting

31

Middlemore Hospital

Auckland, Middlemore, New Zealand, 2025

Actively Recruiting

32

Waikato Hospital

Hamilton, Waikato Region, New Zealand, 3204

Actively Recruiting

33

University Hospital Wishaw

Wishaw, Scotland, United Kingdom

Actively Recruiting

34

Belfast City Hospital

Belfast, United Kingdom, BT9 7AB

Actively Recruiting

35

Southmead Hospital, North Bristol Trust

Bristol, United Kingdom, BS10 5NB

Actively Recruiting

36

Darlington Memorial Hospital

Darlington, United Kingdom, DL3 6HX

Completed

37

Russells Hall Hospital

Dudley, United Kingdom, DY1 2HQ

Actively Recruiting

38

Royal Liverpool and Broadgreen Hospitals

Liverpool, United Kingdom

Actively Recruiting

39

Whittington Hospital

London, United Kingdom, N19 5NF

Actively Recruiting

40

Royal Marsden Hospital - London and Sutton

London, United Kingdom

Actively Recruiting

41

Newcastle upon Tyne Hospitals

Newcastle upon Tyne, United Kingdom

Actively Recruiting

42

Norfolk and Norwich University Hospital

Norwich, United Kingdom, NR4 7UY

Actively Recruiting

43

Rotherham NHS Foundation Trust

Rotherham, United Kingdom, S60 2UD

Actively Recruiting

44

Royal Hallamshire Hospital

Sheffield, United Kingdom, S10 2JF

Actively Recruiting

45

University Hospital Southampton

Southampton, United Kingdom

Actively Recruiting

46

St Helen's Hospital

St Helens, United Kingdom, WA9 3DA

Actively Recruiting

47

Torbay Hospital

Torquay, United Kingdom, TQ2 7AA

Active, Not Recruiting

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Research Team

G

Gillian Ormond

CONTACT

N

Natalie Hird

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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