Long-term Outcomes of Lidocaine Infusions for Post-Operative Pain (LOLIPOP) Trial (NCT05072314) | Clinical Trial Compass
RecruitingPhase 3
Long-term Outcomes of Lidocaine Infusions for Post-Operative Pain (LOLIPOP) Trial
Australia4,300 participantsStarted 2022-07-27
Plain-language 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.
Who can participate
Age range18 Years
SexFEMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
* When immediate autologous reconstruction surgery is planned
* Where delayed autologous reconstruction surgery on the operative breast within one year is planned
* Planned use of regional analgesia infusions
* Impaired cognition
* Pregnant or lactating females
* Transgender patients
* Known metastatic disease
* History of anaphylaxis, sensitivity or known contraindication to lidocaine (or other amide local anaesthetic agents e.g. other amide local anaesthetic agents: ropivacaine, bupivacaine, mepivacaine, prilocaine, etidocaine), includi…
What they're measuring
1
The incidence of moderate or severe CPSP at 1 year after surgery, as reported by the patient at the follow-up review.