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

PHASE3RecruitingINTERVENTIONAL
Enrollment

4,300

Participants

Timeline

Start Date

July 27, 2022

Primary Completion Date

July 31, 2027

Study Completion Date

July 31, 2028

Conditions
Breast CancerBreast Cancer FemaleBreast Conserving SurgeryMastectomy
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"

Trial Locations (43)

1023

RECRUITING

Auckland City Hospital, Auckland

2025

RECRUITING

Middlemore Hospital, Auckland

2035

RECRUITING

Royal North Shore Hospital, Sydney

2145

RECRUITING

Westmead Hospital, Sydney

2217

RECRUITING

St George Hospital, Sydney

2770

RECRUITING

Blacktown Mount Druitt Hospital, Mount Druitt

3004

RECRUITING

The Alfred, Melbourne

3050

RECRUITING

Royal Melbourne Hospital, Melbourne

3065

RECRUITING

St Vincent's Hospital Melbourne, Melbourne

3076

NOT_YET_RECRUITING

Northern Hospital, Melbourne

3135

RECRUITING

Maroondah Hospital - Eastern Health, Ringwood East

3165

COMPLETED

Monash Health - Moorabbin Hospital, Melbourne

3204

RECRUITING

Waikato Hospital, Hamilton

3220

RECRUITING

Barwon Health - University Hospital Geelong, Geelong

3350

COMPLETED

Anaesthetic Group Ballarat, Ballarat

RECRUITING

Ballarat Health Services (Grampians Health), Ballarat

3630

RECRUITING

Goulburn Valley Health, Shepparton

3844

WITHDRAWN

Latrobe Regional Hospital, Traralgon

4029

RECRUITING

Royal Brisbane and Women's Hospital, Brisbane

4102

RECRUITING

Princess Alexandra Hospital, Woolloongabba

4108

RECRUITING

Queen Elizabeth II Jubilee Hospital, Coopers Plains

4215

COMPLETED

Gold Coast Hospital and Health Service- Gold Coast University Hospital, Southport

4700

COMPLETED

Rockhampton Hospital, Rockhampton

4740

RECRUITING

Mackay Base Hospital, Mackay

5042

RECRUITING

Flinders Medical Centre, Bedford Park

6000

RECRUITING

Royal Perth Hospital, Perth

6008

RECRUITING

St John of God Subiaco, Perth

7000

RECRUITING

Royal Hobart Hospital, Hobart

Unknown

RECRUITING

North District Hospital, Shatin

RECRUITING

Pamela Youde Nethersole Eastern Hospital, Chai Wan

RECRUITING

Ruttonjee Hospital, Wan Chai

RECRUITING

University Hospital Wishaw, Wishaw

RECRUITING

Royal Liverpool and Broadgreen Hospitals, Liverpool

RECRUITING

Royal Marsden Hospital, London

RECRUITING

Newcastle upon Tyne Hospitals, Newcastle upon Tyne

RECRUITING

University Hospital Southampton, Southampton

BS10 5NB

RECRUITING

Southmead Hospital, North Bristol Trust, Bristol

DL3 6HX

COMPLETED

Darlington Memorial Hospital, Darlington

DY1 2HQ

RECRUITING

Russells Hall Hospital, Dudley

NR4 7UY

RECRUITING

Norfolk and Norwich University Hospital, Norwich

S60 2UD

RECRUITING

Rotherham NHS Foundation Trust, Rotherham

WA9 3DA

RECRUITING

St Helen's Hospital, St Helens

TQ2 7AA

RECRUITING

Torbay Hospital, Torquay

All Listed Sponsors
collaborator

Royal Perth Hospital

OTHER

lead

Monash University

OTHER