Actively Recruiting
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
Eligibility Criteria
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
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
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
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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