Long-term Outcomes of Lidocaine Infusions for Post-Operative Pain (LOLIPOP) Trial
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexFemale
Age18+
SponsorMonash University
About this trial
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 criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- lidocaine 2% and 10%
- Placebo
Treatment groups
4,300 Participants
are divided into 2 treatment groupsSponsors and collaborators
Monash University
Lead sponsor
Royal Perth Hospital
Collaborator
Source ClinicalTrials.gov