RecruitingPhase 3NCT05072314

Long-term Outcomes of Lidocaine Infusions for Post-Operative Pain (LOLIPOP) Trial

Sponsor

Monash University

Enrollment

4,300 participants

Start Date

Jul 27, 2022

Study Type

INTERVENTIONAL

Conditions

Breast Cancer Mastectomy Breast Cancer Female Breast Conserving Surgery

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

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial tests whether an IV lidocaine infusion given during breast cancer surgery reduces long-term pain and other outcomes compared to a saltwater placebo. **You may be eligible if...** - You are a woman (18 or older) having a mastectomy or breast-conserving surgery for suspected or confirmed primary breast cancer under general anesthesia - Your overall health status is ASA 1–3 **You may NOT be eligible if...** - You are having surgery for a recurrence of breast cancer - You have pre-existing pain at the surgery site or surrounding area - You are having autologous reconstruction (using your own tissue) or a re-excision for unclear margins - You have a known allergy or contraindication to lidocaine or similar local anesthetics - You are pregnant or breastfeeding - You are transgender - You have known metastatic (spread) breast cancer Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGlidocaine 2% and 10%

Lidocaine infusion: 1. Commencing with an intravenous bolus after induction of anaesthesia, 0.125 ml/kg of lean body weight (LBW) of 2% lidocaine (2.5 mg/kg).\* 2. Followed by a 2% lidocaine intravenous infusion for the duration of surgery, 0.1665 ml/kg/h of LBW (3.33 mg/kg/hr).\* 3. A post-operative subcutaneous 0.0222 ml/kg/hr of LBW 10% lidocaine infusion for up to 24 hours thereafter (2.22 mg/kg/hr). Dosage will be capped at a maximum lean body weight of 68kg. * \*Day-case surgery receives intraoperative bolus and intraoperative infusion only

DRUGPlacebo

Placebo infusion: 1. Commencing with an intravenous bolus after induction of anaesthesia, 0.125 ml/kg of lean body weight (LBW) of 0.9% Saline solution.\* 2. Followed by a 0.9% Saline solution intravenous infusion for the duration of surgery, 0.1665 ml/kg/h of LBW (3.33 mg/kg/hr).\* 3. A post-operative subcutaneous 0.0222 ml/kg/hr of LBW 0.9% Saline solution infusion for up to 24 hours thereafter (2.22 mg/kg/hr). Dosage will be capped at a maximum lean body weight of 68kg. * \*Day-case surgery receives intraoperative bolus and intraoperative infusion only

Locations(47)

Nepean Hospital

Kingswood, New South Wales, Australia

Blacktown Mount Druitt Hospital

Mount Druitt, New South Wales, Australia

Royal North Shore Hospital

Sydney, New South Wales, Australia

Westmead Hospital

Sydney, New South Wales, Australia

St George Hospital

Sydney, New South Wales, Australia

Royal Brisbane and Women's Hospital

Brisbane, Queensland, Australia

Queen Elizabeth II Jubilee Hospital

Coopers Plains, Queensland, Australia

Mackay Base Hospital

Mackay, Queensland, Australia

Rockhampton Hospital

Rockhampton, Queensland, Australia

Gold Coast Hospital and Health Service- Gold Coast University Hospital

Southport, Queensland, Australia

Princess Alexandra Hospital

Woolloongabba, Queensland, Australia

Flinders Medical Centre

Bedford Park, South Australia, Australia

Royal Hobart Hospital

Hobart, Tasmania, Australia

Anaesthetic Group Ballarat

Ballarat, Victoria, Australia

Ballarat Health Services (Grampians Health)

Ballarat, Victoria, Australia

Barwon Health - University Hospital Geelong

Geelong, Victoria, Australia

The Alfred