Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
MY TRIALS
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Register a trial
The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT05072314
Registration number
NCT05072314
Ethics application status
Date submitted
3/10/2021
Date registered
8/10/2021
Titles & IDs
Public title
Long-term Outcomes of Lidocaine Infusions for Post-Operative Pain (LOLIPOP) Trial
Query!
Scientific title
Long-term Outcomes of Lidocaine Infusions for Post-Operative Pain (LOLIPOP) Trial
Query!
Secondary ID [1]
0
0
HREC/74777/Alfred-2021
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
LOLIPOP
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Breast Cancer
0
0
Query!
Breast Cancer Female
0
0
Query!
Breast Conserving Surgery
0
0
Query!
Mastectomy
0
0
Query!
Condition category
Condition code
Cancer
0
0
0
0
Query!
Breast
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Treatment: Drugs - lidocaine 2% and 10%
Treatment: Drugs - Placebo
Active comparator: Lidocaine - 2% Lidocaine infusion intra-operative and 10% Lidocaine infusion post-operative.
Placebo comparator: Placebo - 0.9% Saline infusion intra-operative and 0.9% Saline infusion post-operative.
Treatment: Drugs: 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
Treatment: Drugs: 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
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
The incidence of moderate or severe CPSP at 1 year after surgery, as reported by the patient at the follow-up review.
Query!
Assessment method [1]
0
0
Numerical rating scale =4 out of 10 for worst pain in the last week - The pain must have been present for at least 3 months prior to the one year assessment (or longer).
Query!
Timepoint [1]
0
0
1 year post-surgery
Query!
Secondary outcome [1]
0
0
Severity of acute postoperative pain at rest
Query!
Assessment method [1]
0
0
Maximum pain score, Numerical rating scale (NRS) 0-10
Query!
Timepoint [1]
0
0
24 hours postoperatively
Query!
Secondary outcome [2]
0
0
Severity of Acute postoperative pain on movement
Query!
Assessment method [2]
0
0
Maximum pain score, Numerical rating scale (NRS) 0-10
Query!
Timepoint [2]
0
0
24 hours postoperatively
Query!
Secondary outcome [3]
0
0
Postoperative opioid consumption
Query!
Assessment method [3]
0
0
Morphine Equivalent Opioid Consumption (MEQ)
Query!
Timepoint [3]
0
0
on Day 1
Query!
Secondary outcome [4]
0
0
Postoperative opioid consumption
Query!
Assessment method [4]
0
0
Morphine Equivalent Opioid Consumption (MEQ)
Query!
Timepoint [4]
0
0
3 months (last 24-hours)
Query!
Secondary outcome [5]
0
0
The Incidence of moderate to severe Chronic Post Surgical Pain from radiation therapy
Query!
Assessment method [5]
0
0
with a significant contribution from radiation therapy
Query!
Timepoint [5]
0
0
1 year post surgery
Query!
Secondary outcome [6]
0
0
The Incidence of moderate to severe Chronic Post Surgical Pain from repeat surgery
Query!
Assessment method [6]
0
0
with a significant contribution from repeat surgery
Query!
Timepoint [6]
0
0
1 year post surgery
Query!
Secondary outcome [7]
0
0
The incidence of severe CPSP at 1 year after surgery
Query!
Assessment method [7]
0
0
NRS for worst pain the in the last week of =7)
Query!
Timepoint [7]
0
0
1 year post surgery
Query!
Secondary outcome [8]
0
0
The incidence of mild or greater CPSP at 1 year after surgery
Query!
Assessment method [8]
0
0
NRS for worst pain the in the last week of =1
Query!
Timepoint [8]
0
0
1 year post surgery
Query!
Secondary outcome [9]
0
0
The incidence of discomfort or altered sensation at the site of surgery (not reported as pain)
Query!
Assessment method [9]
0
0
Patients asked if they have any altered sensation at the site of surgery
Query!
Timepoint [9]
0
0
1 year post surgery
Query!
Secondary outcome [10]
0
0
Severity of CPSP
Query!
Assessment method [10]
0
0
Assessed using "average" and "worst" NRS pain score in the last week, obtained from the adapted modified Brief Pain Inventory-Short Form (mBPI-SF)
Query!
Timepoint [10]
0
0
1 year post surgery
Query!
Secondary outcome [11]
0
0
Incidence of neuropathic symptoms
Query!
Assessment method [11]
0
0
Incidence examined as a binary outcome using the Short Form of Douleur Neuropathique 4 Questions (S-DN4)
Query!
Timepoint [11]
0
0
1 year post surgery
Query!
Secondary outcome [12]
0
0
Postoperative opioid consumption
Query!
Assessment method [12]
0
0
Morphine Equivalent Opioid Consumption (MEQ)
Query!
Timepoint [12]
0
0
1 year post surgery (last 24 hours)
Query!
Secondary outcome [13]
0
0
Physical functioning
Query!
Assessment method [13]
0
0
Using interference component of mBPI-SF
Query!
Timepoint [13]
0
0
1 year post surgery
Query!
Secondary outcome [14]
0
0
Changes in quality of life metrics EuroQol 5 Dimension 5 Level (EQ-5D-5L) at 1 year after surgery compared to baseline
Query!
Assessment method [14]
0
0
Changes in the quality of life
Query!
Timepoint [14]
0
0
1 year post surgery
Query!
Secondary outcome [15]
0
0
Changes in psychological wellbeing Kessler Psychological Distress Scale (K-10) at 1 year after surgery compared to baseline.
Query!
Assessment method [15]
0
0
Changes in psychological wellbeing
Query!
Timepoint [15]
0
0
1 year post surgery
Query!
Secondary outcome [16]
0
0
The incidence of mortality at 1 year
Query!
Assessment method [16]
0
0
Mortality at 1 year
Query!
Timepoint [16]
0
0
1 year post surgery
Query!
Secondary outcome [17]
0
0
UK NHS costs of care over 1 year following surgery
Query!
Assessment method [17]
0
0
UK/NHS sites only
Query!
Timepoint [17]
0
0
1 year post surgery
Query!
Secondary outcome [18]
0
0
Productivity costs over 1 year following surgery
Query!
Assessment method [18]
0
0
UK/NHS sites only
Query!
Timepoint [18]
0
0
1 year post surgery
Query!
Secondary outcome [19]
0
0
Quality-adjusted life years (QALYs) over 1 year following surgery
Query!
Assessment method [19]
0
0
UK/NHS sites only
Query!
Timepoint [19]
0
0
1 year post surgery
Query!
Secondary outcome [20]
0
0
Cost-effectiveness of perioperative lidocaine infusions compared to usual care, from a primary UK NHS perspective and broader perspective including productivity, at 1 year.
Query!
Assessment method [20]
0
0
UK/NHS sites only
Query!
Timepoint [20]
0
0
1 year post surgery
Query!
Eligibility
Key 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 breast cancer under general anaesthesia (including those with simultaneous insertion of tissue expanders or implants).
* American Society of Anaesthesiologist (ASA) physical scale 1-3
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
* Pre-existing pain at site of surgery, axilla, ipsilateral side of chest wall or the ipsilateral upper arm
* 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), including patients with porphyria or methaemoglobinaemia
* History of epilepsy
* Baseline heart rate < 50 bpm or systolic blood pressure < 100mmHg.
* Acute coronary event in the last three months
* Cardiac conduction abnormalities, including; Atrial fibrillation, Heart block (all degrees), Bundle Branch Block or Fascicular block, Prolonged QT interval, Wolf Parkinson White syndrome, channelopathy such as Brugada syndrome. A preoperative Electrocardiogram (ECG) is not mandatory, unless clinically indicated
* Abnormal serum potassium concentration (based upon site laboratory reference ranges)
* Abnormal serum sodium concentration (based upon site laboratory reference ranges)
* Active liver disease e.g. viral hepatitis, alcoholic liver disease, non-alcoholic fatty liver disease, haemochromatosis, other rarer causes)
* Medications within the last 7 days which are known / suspected to slow lidocaine metabolism (amiodarone, beta blockers, cimetidine, fluoroquinolones, fluvoxamine, imidazoles, macrolides, verapamil, HIV drugs)
* Cardiac Failure (any documented heart failure at peroperative assessment or GP records)
* Severe Renal Failure (Creatinine Clearance of less than 30ml/min or dialysis dependent)
* Co-administration of lidocaine within 24 hours prior to surgery for other reasons (e.g. lidocaine patches
Query!
Study design
Purpose of the study
Prevention
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Blinded (masking used)
Query!
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 4
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Recruiting
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
27/07/2022
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
1/07/2028
Query!
Actual
Query!
Sample size
Target
4300
Query!
Accrual to date
Query!
Final
Query!
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,TAS,VIC,WA
Query!
Recruitment hospital [1]
0
0
Prince of Wales Hospital - Sydney
Query!
Recruitment hospital [2]
0
0
Royal North Shore Hospital - Sydney
Query!
Recruitment hospital [3]
0
0
Westmead Hospital - Sydney
Query!
Recruitment hospital [4]
0
0
St George Hospital - Sydney
Query!
Recruitment hospital [5]
0
0
Royal Brisbane and Women's Hospital - Brisbane
Query!
Recruitment hospital [6]
0
0
Queen Elizabeth II Jubilee Hospital - Coopers Plains
Query!
Recruitment hospital [7]
0
0
Mackay Base Hospital - Mackay
Query!
Recruitment hospital [8]
0
0
Rockhampton Hospital - Rockhampton
Query!
Recruitment hospital [9]
0
0
Gold Coast Hospital and Health Service- Gold Coast University Hospital - Southport
Query!
Recruitment hospital [10]
0
0
Princess Alexandra Hospital - Woolloongabba
Query!
Recruitment hospital [11]
0
0
Flinders Medical Centre - Bedford Park
Query!
Recruitment hospital [12]
0
0
Royal Hobart Hospital - Hobart
Query!
Recruitment hospital [13]
0
0
Anaesthetic Group Ballarat - Ballarat
Query!
Recruitment hospital [14]
0
0
Ballarat Health Services (Grampians Health) - Ballarat
Query!
Recruitment hospital [15]
0
0
Barwon Health - University Hospital Geelong - Geelong
Query!
Recruitment hospital [16]
0
0
The Alfred - Melbourne
Query!
Recruitment hospital [17]
0
0
Royal Melbourne Hospital - Melbourne
Query!
Recruitment hospital [18]
0
0
St Vincent's Hospital Melbourne - Melbourne
Query!
Recruitment hospital [19]
0
0
Northern Hospital - Melbourne
Query!
Recruitment hospital [20]
0
0
Monash Health - Moorabbin Hospital - Melbourne
Query!
Recruitment hospital [21]
0
0
Maroondah Hospital - Eastern Health - Ringwood East
Query!
Recruitment hospital [22]
0
0
Goulburn Valley Health - Shepparton
Query!
Recruitment hospital [23]
0
0
Latrobe Regional Hospital - Traralgon
Query!
Recruitment hospital [24]
0
0
Royal Perth Hospital - Perth
Query!
Recruitment hospital [25]
0
0
St John of God Subiaco - Perth
Query!
Recruitment postcode(s) [1]
0
0
2031 - Sydney
Query!
Recruitment postcode(s) [2]
0
0
2035 - Sydney
Query!
Recruitment postcode(s) [3]
0
0
2145 - Sydney
Query!
Recruitment postcode(s) [4]
0
0
2217 - Sydney
Query!
Recruitment postcode(s) [5]
0
0
4029 - Brisbane
Query!
Recruitment postcode(s) [6]
0
0
4108 - Coopers Plains
Query!
Recruitment postcode(s) [7]
0
0
4740 - Mackay
Query!
Recruitment postcode(s) [8]
0
0
4700 - Rockhampton
Query!
Recruitment postcode(s) [9]
0
0
4215 - Southport
Query!
Recruitment postcode(s) [10]
0
0
4102 - Woolloongabba
Query!
Recruitment postcode(s) [11]
0
0
5042 - Bedford Park
Query!
Recruitment postcode(s) [12]
0
0
7000 - Hobart
Query!
Recruitment postcode(s) [13]
0
0
3350 - Ballarat
Query!
Recruitment postcode(s) [14]
0
0
3220 - Geelong
Query!
Recruitment postcode(s) [15]
0
0
3004 - Melbourne
Query!
Recruitment postcode(s) [16]
0
0
3050 - Melbourne
Query!
Recruitment postcode(s) [17]
0
0
3065 - Melbourne
Query!
Recruitment postcode(s) [18]
0
0
3076 - Melbourne
Query!
Recruitment postcode(s) [19]
0
0
3165 - Melbourne
Query!
Recruitment postcode(s) [20]
0
0
3135 - Ringwood East
Query!
Recruitment postcode(s) [21]
0
0
3630 - Shepparton
Query!
Recruitment postcode(s) [22]
0
0
3844 - Traralgon
Query!
Recruitment postcode(s) [23]
0
0
6000 - Perth
Query!
Recruitment postcode(s) [24]
0
0
6008 - Perth
Query!
Recruitment outside Australia
Country [1]
0
0
Hong Kong
Query!
State/province [1]
0
0
Chai Wan
Query!
Country [2]
0
0
Hong Kong
Query!
State/province [2]
0
0
Sha Tin
Query!
Country [3]
0
0
Hong Kong
Query!
State/province [3]
0
0
Wan Chai
Query!
Country [4]
0
0
New Zealand
Query!
State/province [4]
0
0
Waikato
Query!
Country [5]
0
0
New Zealand
Query!
State/province [5]
0
0
Auckland
Query!
Country [6]
0
0
United Kingdom
Query!
State/province [6]
0
0
Belfast
Query!
Country [7]
0
0
United Kingdom
Query!
State/province [7]
0
0
Bristol
Query!
Country [8]
0
0
United Kingdom
Query!
State/province [8]
0
0
Dudley
Query!
Country [9]
0
0
United Kingdom
Query!
State/province [9]
0
0
Leicester
Query!
Country [10]
0
0
United Kingdom
Query!
State/province [10]
0
0
Liverpool
Query!
Country [11]
0
0
United Kingdom
Query!
State/province [11]
0
0
Redhill
Query!
Country [12]
0
0
United Kingdom
Query!
State/province [12]
0
0
Southampton
Query!
Funding & Sponsors
Primary sponsor type
Other
Query!
Name
Monash University
Query!
Address
Query!
Country
Query!
Other collaborator category [1]
0
0
Other
Query!
Name [1]
0
0
Royal Perth Hospital
Query!
Address [1]
0
0
Query!
Country [1]
0
0
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief 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.
Query!
Trial website
https://clinicaltrials.gov/study/NCT05072314
Query!
Trial related presentations / publications
Toner AJ, Bailey MA, Schug SA, Corcoran TB. A pilot multicentre randomised controlled trial of lidocaine infusion in women undergoing breast cancer surgery. Anaesthesia. 2021 Oct;76(10):1326-1341. doi: 10.1111/anae.15440. Epub 2021 Mar 2. Toner AJ, Bailey MA, Schug SA, Phillips M, Ungerer JP, Somogyi AA, Corcoran TB. Serum lidocaine (lignocaine) concentrations during prolonged perioperative infusion in patients undergoing breast cancer surgery: A secondary analysis of a randomised controlled trial. Anaesth Intensive Care. 2023 Nov;51(6):422-431. doi: 10.1177/0310057X231194833. Epub 2023 Oct 6.
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Tomas Corcoran
Query!
Address
0
0
Royal Perth Hospital
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Gillian Ormond
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
+61 (03) 9903 0387
Query!
Fax
0
0
Query!
Email
0
0
[email protected]
Query!
Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
Query!
No/undecided IPD sharing reason/comment
Query!
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT05072314