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RECRUITING
NCT05072314
PHASE3

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

Sponsor: Monash University

View on ClinicalTrials.gov

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.

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

4300

Start Date

2022-07-27

Completion Date

2028-07

Last Updated

2026-03-25

Healthy Volunteers

No

Interventions

DRUG

lidocaine 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

DRUG

Placebo

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

Melbourne, Victoria, Australia

Royal Melbourne Hospital

Melbourne, Victoria, Australia

St Vincent's Hospital Melbourne

Melbourne, Victoria, Australia

Northern Hospital

Melbourne, Victoria, Australia

Monash Health - Moorabbin Hospital

Melbourne, Victoria, Australia

Maroondah Hospital - Eastern Health

Ringwood East, Victoria, Australia

Goulburn Valley Health

Shepparton, Victoria, Australia

Latrobe Regional Hospital

Traralgon, Victoria, Australia

Royal Perth Hospital

Perth, Western Australia, Australia

St John of God Subiaco

Perth, Western Australia, Australia

North District Hospital

Shatin, Sha Tin, Hong Kong

Pamela Youde Nethersole Eastern Hospital

Chai Wan, Hong Kong

Ruttonjee Hospital

Wan Chai, Hong Kong

Auckland City Hospital

Auckland, Auckland, New Zealand

Middlemore Hospital

Auckland, Middlemore, New Zealand

Waikato Hospital

Hamilton, Waikato Region, New Zealand

University Hospital Wishaw

Wishaw, Scotland, United Kingdom

Belfast City Hospital

Belfast, United Kingdom

Southmead Hospital, North Bristol Trust

Bristol, United Kingdom

Darlington Memorial Hospital

Darlington, United Kingdom

Russells Hall Hospital

Dudley, United Kingdom

Royal Liverpool and Broadgreen Hospitals

Liverpool, United Kingdom

Whittington Hospital

London, United Kingdom

Royal Marsden Hospital - London and Sutton

London, United Kingdom

Newcastle upon Tyne Hospitals

Newcastle upon Tyne, United Kingdom

Norfolk and Norwich University Hospital

Norwich, United Kingdom

Rotherham NHS Foundation Trust

Rotherham, United Kingdom

Royal Hallamshire Hospital

Sheffield, United Kingdom

University Hospital Southampton

Southampton, United Kingdom

St Helen's Hospital

St Helens, United Kingdom

Torbay Hospital

Torquay, United Kingdom