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Clinical Trial Summary

The LOLIPOP Trial is a large (n=4,300 patients) pragmatic, international, multicentre, prospective, randomised, double blind, placebo-controlled, parallel assessment, stratified safety and effectiveness superiority study.

Clinical Trial Description

The Trial's purpose is to evaluate the effectiveness of lidocaine infusions commenced during surgery and extending up to 24 hours postoperatively, on the incidence of moderate or severe chronic post-surgical pain (CPSP) detected one year following surgery in female patients undergoing elective breast cancer surgery. Patients will be stratified according to whether they undergo breast conserving surgery or mastectomy, and whether they have preoperative chronic pain at a site other than the surgical site. The trial has 90% power to detect a clinically meaningful (25%) reduction in the incidence of the primary outcome. Secondary outcomes include safety events, analgesic efficacy (pain scores and opioid consumption), neuropathic characteristics of CPSP, and psychological and quality of life outcomes. ;

Study Design

Related Conditions & MeSH terms

NCT number NCT05072314
Study type Interventional
Source Monash University
Contact Gillian Ormond
Phone +61 (03) 9903 0387
Email [email protected]
Status Not yet recruiting
Phase Phase 4
Start date February 2022
Completion date February 2028

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