Long-term Outcomes of Lidocaine Infusions for Post-Operative Pain (LOLIPOP) Trial
Status: Recruiting
Location: See all (45) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
Australia
Anaesthetic Group Ballarat
TERMINATED
Ballarat
Ballarat Health Services (Grampians Health)
RECRUITING
Ballarat
Flinders Medical Centre
RECRUITING
Bedford Park
Royal Brisbane and Women's Hospital
RECRUITING
Brisbane
Queen Elizabeth II Jubilee Hospital
RECRUITING
Coopers Plains
Barwon Health - University Hospital Geelong
RECRUITING
Geelong
Royal Hobart Hospital
RECRUITING
Hobart
Mackay Base Hospital
RECRUITING
Mackay
Monash Health - Moorabbin Hospital
COMPLETED
Melbourne
Northern Hospital
NOT_YET_RECRUITING
Melbourne
Royal Melbourne Hospital
RECRUITING
Melbourne
St Vincent's Hospital Melbourne
RECRUITING
Melbourne
The Alfred
RECRUITING
Melbourne
Blacktown Mount Druitt Hospital
RECRUITING
Mount Druitt
Royal Perth Hospital
RECRUITING
Perth
St John of God Subiaco
RECRUITING
Perth
Maroondah Hospital - Eastern Health
RECRUITING
Ringwood East
Rockhampton Hospital
TERMINATED
Rockhampton
Goulburn Valley Health
TERMINATED
Shepparton
Gold Coast Hospital and Health Service- Gold Coast University Hospital
TERMINATED
Southport
Royal North Shore Hospital
RECRUITING
Sydney
St George Hospital
RECRUITING
Sydney
Westmead Hospital
RECRUITING
Sydney
Latrobe Regional Hospital
WITHDRAWN
Traralgon
Princess Alexandra Hospital
RECRUITING
Woolloongabba
Hong Kong Special Administrative Region
Pamela Youde Nethersole Eastern Hospital
RECRUITING
Chai Wan
North District Hospital
RECRUITING
Shatin
Ruttonjee Hospital
RECRUITING
Wan Chai
New Zealand
Auckland City Hospital
RECRUITING
Auckland
Middlemore Hospital
RECRUITING
Auckland
Waikato Hospital
RECRUITING
Hamilton
United Kingdom
Belfast City Hospital
RECRUITING
Belfast
Southmead Hospital, North Bristol Trust
RECRUITING
Bristol
Darlington Memorial Hospital
COMPLETED
Darlington
Russells Hall Hospital
RECRUITING
Dudley
Royal Liverpool and Broadgreen Hospitals
RECRUITING
Liverpool
Royal Marsden Hospital
RECRUITING
London
Whittington Hospital
RECRUITING
London
Newcastle upon Tyne Hospitals
RECRUITING
Newcastle Upon Tyne
Norfolk and Norwich University Hospital
RECRUITING
Norwich
Rotherham NHS Foundation Trust
RECRUITING
Rotherham
University Hospital Southampton
RECRUITING
Southampton
St Helen's Hospital
RECRUITING
St Helens
Torbay Hospital
RECRUITING
Torquay
University Hospital Wishaw
RECRUITING
Wishaw
Contact Information
Primary
Gillian Ormond
gillian.ormond@monash.edu
+610399030387
Backup
Natalie Hird
natalie.hird@health.wa.gov.au
+61 (0) 459 407 231
Time Frame
Start Date: 2022-07-27
Estimated Completion Date: 2028-07
Participants
Target number of participants: 4300
Treatments
Active_comparator: Lidocaine
2% Lidocaine infusion intra-operative and 10% Lidocaine infusion post-operative.
Placebo_comparator: Placebo
0.9% Saline infusion intra-operative and 0.9% Saline infusion post-operative.
Related Therapeutic Areas
Sponsors
Leads: Monash University
Collaborators: Royal Perth Hospital