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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
Date last updated
26/10/2024

Titles & IDs
Public title
Long-term Outcomes of Lidocaine Infusions for Post-Operative Pain (LOLIPOP) Trial
Scientific title
Long-term Outcomes of Lidocaine Infusions for Post-Operative Pain (LOLIPOP) Trial
Secondary ID [1] 0 0
HREC/74777/Alfred-2021
Universal Trial Number (UTN)
Trial acronym
LOLIPOP
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast Cancer 0 0
Breast Cancer Female 0 0
Breast Conserving Surgery 0 0
Mastectomy 0 0
Condition category
Condition code
Cancer 0 0 0 0
Breast

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

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.
Timepoint [1] 0 0
1 year post-surgery
Secondary outcome [1] 0 0
Severity of acute postoperative pain at rest
Timepoint [1] 0 0
24 hours postoperatively
Secondary outcome [2] 0 0
Severity of Acute postoperative pain on movement
Timepoint [2] 0 0
24 hours postoperatively
Secondary outcome [3] 0 0
Postoperative opioid consumption
Timepoint [3] 0 0
on Day 1
Secondary outcome [4] 0 0
Postoperative opioid consumption
Timepoint [4] 0 0
3 months (last 24-hours)
Secondary outcome [5] 0 0
The Incidence of moderate to severe Chronic Post Surgical Pain from radiation therapy
Timepoint [5] 0 0
1 year post surgery
Secondary outcome [6] 0 0
The Incidence of moderate to severe Chronic Post Surgical Pain from repeat surgery
Timepoint [6] 0 0
1 year post surgery
Secondary outcome [7] 0 0
The incidence of severe CPSP at 1 year after surgery
Timepoint [7] 0 0
1 year post surgery
Secondary outcome [8] 0 0
The incidence of mild or greater CPSP at 1 year after surgery
Timepoint [8] 0 0
1 year post surgery
Secondary outcome [9] 0 0
The incidence of discomfort or altered sensation at the site of surgery (not reported as pain)
Timepoint [9] 0 0
1 year post surgery
Secondary outcome [10] 0 0
Severity of CPSP
Timepoint [10] 0 0
1 year post surgery
Secondary outcome [11] 0 0
Incidence of neuropathic symptoms
Timepoint [11] 0 0
1 year post surgery
Secondary outcome [12] 0 0
Postoperative opioid consumption
Timepoint [12] 0 0
1 year post surgery (last 24 hours)
Secondary outcome [13] 0 0
Physical functioning
Timepoint [13] 0 0
1 year post surgery
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
Timepoint [14] 0 0
1 year post surgery
Secondary outcome [15] 0 0
Changes in psychological wellbeing Kessler Psychological Distress Scale (K-10) at 1 year after surgery compared to baseline.
Timepoint [15] 0 0
1 year post surgery
Secondary outcome [16] 0 0
The incidence of mortality at 1 year
Timepoint [16] 0 0
1 year post surgery
Secondary outcome [17] 0 0
UK NHS costs of care over 1 year following surgery
Timepoint [17] 0 0
1 year post surgery
Secondary outcome [18] 0 0
Productivity costs over 1 year following surgery
Timepoint [18] 0 0
1 year post surgery
Secondary outcome [19] 0 0
Quality-adjusted life years (QALYs) over 1 year following surgery
Timepoint [19] 0 0
1 year post surgery
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.
Timepoint [20] 0 0
1 year post surgery

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
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
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
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
27/07/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/07/2028
Actual
Sample size
Target
4300
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,TAS,VIC,WA
Recruitment hospital [1] 0 0
Prince of Wales Hospital - Sydney
Recruitment hospital [2] 0 0
Royal North Shore Hospital - Sydney
Recruitment hospital [3] 0 0
Westmead Hospital - Sydney
Recruitment hospital [4] 0 0
St George Hospital - Sydney
Recruitment hospital [5] 0 0
Royal Brisbane and Women's Hospital - Brisbane
Recruitment hospital [6] 0 0
Queen Elizabeth II Jubilee Hospital - Coopers Plains
Recruitment hospital [7] 0 0
Mackay Base Hospital - Mackay
Recruitment hospital [8] 0 0
Rockhampton Hospital - Rockhampton
Recruitment hospital [9] 0 0
Gold Coast Hospital and Health Service- Gold Coast University Hospital - Southport
Recruitment hospital [10] 0 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [11] 0 0
Flinders Medical Centre - Bedford Park
Recruitment hospital [12] 0 0
Royal Hobart Hospital - Hobart
Recruitment hospital [13] 0 0
Anaesthetic Group Ballarat - Ballarat
Recruitment hospital [14] 0 0
Ballarat Health Services (Grampians Health) - Ballarat
Recruitment hospital [15] 0 0
Barwon Health - University Hospital Geelong - Geelong
Recruitment hospital [16] 0 0
The Alfred - Melbourne
Recruitment hospital [17] 0 0
Royal Melbourne Hospital - Melbourne
Recruitment hospital [18] 0 0
St Vincent's Hospital Melbourne - Melbourne
Recruitment hospital [19] 0 0
Northern Hospital - Melbourne
Recruitment hospital [20] 0 0
Monash Health - Moorabbin Hospital - Melbourne
Recruitment hospital [21] 0 0
Maroondah Hospital - Eastern Health - Ringwood East
Recruitment hospital [22] 0 0
Goulburn Valley Health - Shepparton
Recruitment hospital [23] 0 0
Latrobe Regional Hospital - Traralgon
Recruitment hospital [24] 0 0
Royal Perth Hospital - Perth
Recruitment hospital [25] 0 0
St John of God Subiaco - Perth
Recruitment postcode(s) [1] 0 0
2031 - Sydney
Recruitment postcode(s) [2] 0 0
2035 - Sydney
Recruitment postcode(s) [3] 0 0
2145 - Sydney
Recruitment postcode(s) [4] 0 0
2217 - Sydney
Recruitment postcode(s) [5] 0 0
4029 - Brisbane
Recruitment postcode(s) [6] 0 0
4108 - Coopers Plains
Recruitment postcode(s) [7] 0 0
4740 - Mackay
Recruitment postcode(s) [8] 0 0
4700 - Rockhampton
Recruitment postcode(s) [9] 0 0
4215 - Southport
Recruitment postcode(s) [10] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [11] 0 0
5042 - Bedford Park
Recruitment postcode(s) [12] 0 0
7000 - Hobart
Recruitment postcode(s) [13] 0 0
3350 - Ballarat
Recruitment postcode(s) [14] 0 0
3220 - Geelong
Recruitment postcode(s) [15] 0 0
3004 - Melbourne
Recruitment postcode(s) [16] 0 0
3050 - Melbourne
Recruitment postcode(s) [17] 0 0
3065 - Melbourne
Recruitment postcode(s) [18] 0 0
3076 - Melbourne
Recruitment postcode(s) [19] 0 0
3165 - Melbourne
Recruitment postcode(s) [20] 0 0
3135 - Ringwood East
Recruitment postcode(s) [21] 0 0
3630 - Shepparton
Recruitment postcode(s) [22] 0 0
3844 - Traralgon
Recruitment postcode(s) [23] 0 0
6000 - Perth
Recruitment postcode(s) [24] 0 0
6008 - Perth
Recruitment outside Australia
Country [1] 0 0
Hong Kong
State/province [1] 0 0
Chai Wan
Country [2] 0 0
Hong Kong
State/province [2] 0 0
Sha Tin
Country [3] 0 0
Hong Kong
State/province [3] 0 0
Wan Chai
Country [4] 0 0
New Zealand
State/province [4] 0 0
Waikato
Country [5] 0 0
New Zealand
State/province [5] 0 0
Auckland
Country [6] 0 0
United Kingdom
State/province [6] 0 0
Belfast
Country [7] 0 0
United Kingdom
State/province [7] 0 0
Bristol
Country [8] 0 0
United Kingdom
State/province [8] 0 0
Dudley
Country [9] 0 0
United Kingdom
State/province [9] 0 0
Leicester
Country [10] 0 0
United Kingdom
State/province [10] 0 0
Liverpool
Country [11] 0 0
United Kingdom
State/province [11] 0 0
Redhill
Country [12] 0 0
United Kingdom
State/province [12] 0 0
Southampton

Funding & Sponsors
Primary sponsor type
Other
Name
Monash University
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Royal Perth Hospital
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/study/NCT05072314
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.
Public notes

Contacts
Principal investigator
Name 0 0
Tomas Corcoran
Address 0 0
Royal Perth Hospital
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Gillian Ormond
Address 0 0
Country 0 0
Phone 0 0
+610399030387
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT05072314