Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001658202
Ethics application status
Approved
Date submitted
4/10/2018
Date registered
8/10/2018
Date last updated
18/09/2019
Date data sharing statement initially provided
18/09/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Lignocaine Infusion in Obesity
Scientific title
Intraoperative Lignocaine Infusions: development of an optimised infusion dosing regimen for obese patients
Secondary ID [1] 296260 0
None
Universal Trial Number (UTN)
U1111-1221-6720
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Bariatrics (Obesity) 309925 0
Condition category
Condition code
Anaesthesiology 308699 308699 0 0
Anaesthetics
Diet and Nutrition 308722 308722 0 0
Obesity
Surgery 308723 308723 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intravenous lignocaine infusion of 1.5mg/kg bolus over 10 minutes on induction of anaesthesia followed by 1.5mg/kg/hour throughout the duration of patient's laparoscopic abdominal procedure which will vary depending on each individual patient's specific surgical requirements.

Intravenous lignocaine infusions are widely regarded as a valuable adjunct to laparoscopic abdominal surgical procedures however their use in this population group, with the current level of evidence, is entirely dependant on anaesthetist preference. As such in some cases intravenous lignocaine infusions would be used regardless but in some cases they will be utilised specifically for the purposes of the study
Intervention code [1] 312588 0
Treatment: Drugs
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 307674 0
Plasma Lignocaine Levels
Timepoint [1] 307674 0
No specific primary timepoint - aim is to measure levels over 4 hours and model continuously over this time period. The protocol outlines that the following anticipated measurement timepoints - T5minutes post lignocaine bolus completion and then T30minutes, T6o minutes, T120minutes, T180minutes and T240minutes
Secondary outcome [1] 352546 0
Plasma levels of the primary lignocaine active metabolite - monoethylglycinexylididem (MEGX)
Timepoint [1] 352546 0
The protocol outlines that the following anticipated measurement timepoints - T5minutes post lignocaine bolus completion and then T30minutes, T6o minutes, T120minutes, T180minutes and T240minutes
Secondary outcome [2] 352585 0
Plasma levels of the secondary lignocaine active metabolite - glycylxylidide (GX
Timepoint [2] 352585 0
The protocol outlines that the following anticipated measurement timepoints - T5minutes post lignocaine bolus completion and then T30minutes, T6o minutes, T120minutes, T180minutes and T240minutes
Secondary outcome [3] 352586 0
Plasma levels of alpha-1-glycoprotein
Timepoint [3] 352586 0
The protocol outlines that the following anticipated measurement timepoints - T5minutes post lignocaine bolus completion and then T30minutes, T6o minutes, T120minutes, T180minutes and T240minutes

Eligibility
Key inclusion criteria
Patients scheduled for elective laparoscopic abdominal surgery

Surgical duration expected to be of at least 90 minutes duration

Patients of a range of BMIs according to the WHO definitions - 10 patients with a BMI of < 35kg/m2, 10 patients with a BMI of 35-40kg/m2 and 10 patients with a BMI > 40kg/m2

Informed consent by patient or legally authorised representative to participate in study and to store specimens for immediate and future analysis.
Minimum age
18 Years
Maximum age
90 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Known or suspected allergy to study drug (lignocaine)

Acute or chronic renal disease (eGFR < 60)

Acute or chronic liver disease

Congestive cardiac failure

Cardiac conduction abnormalities

Pregnancy

History of seizure disorder

Known vascular disease of the upper limb (e.g. Raynauds disease), or other contraindication to arterial catheterisation

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
N/A
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
N/A
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
An open-label plasma pharmacokinetic study of lignocaine infusions in the perioperative setting
Phase
Phase 3 / Phase 4
Type of endpoint/s
Pharmacokinetics
Statistical methods / analysis
Analysis of lignocaine infusions in the bariatric population will be guided by Professor Jason Roberts and his pharmacometric team but at this stage it is anticipated to assess: total and free lignocaine concentrations, Cmax, tmax, Vd, elimination half-life, clearance and area under the curve. Added into this modelling will be data in regards to MEGX and GX concentrations, Cmax and max along with AAG levels which are particularly variable with obesity and will potentially alter the active lignocaine concentration levels by altering the bound fraction.

The pharmacometric team at the RBWH Burns, Trauma and Critical Research Centre will then use PMetrics software to develop population pharmacokinetic modelling followed by regression analysis to statistically validate the model and apply Monte-Carlo simulation to create a population model of 1000 patients.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
3/12/2018
Actual
10/06/2019
Date of last participant enrolment
Anticipated
1/01/2020
Actual
Date of last data collection
Anticipated
31/01/2020
Actual
Sample size
Target
30
Accrual to date
29
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 12106 0
Royal Brisbane & Womens Hospital - Herston
Recruitment postcode(s) [1] 24268 0
4029 - Herston

Funding & Sponsors
Funding source category [1] 300854 0
Hospital
Name [1] 300854 0
Royal Brisbane and Women's Hospital Anaesthetic Research Department
Country [1] 300854 0
Australia
Primary sponsor type
Hospital
Name
RBWH Anaesthetic Department
Address
Royal Brisbane and Women's Hospital
Cnr of Bowen Bridge Road and Butterfield Street
Herston
Queensland
4029
Country
Australia
Secondary sponsor category [1] 300406 0
Individual
Name [1] 300406 0
Dr Angela Tognolini
Address [1] 300406 0
C/O Anaesthetic Research Department
Royal Brisbane and Women's Hospital
Cnr of Bowen Bridge Road and Butterfield Street
Herston
Queensland
4029
Country [1] 300406 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301629 0
The Prince Charles Hospital Human Research Ethics Committee (TPCH HREC - EC00168)
Ethics committee address [1] 301629 0
C/O the TPCH Research Committee Executive Officer
The Prince Charles Hospital
627 Rode Road
Chermside
Queensland
4032
Ethics committee country [1] 301629 0
Australia
Date submitted for ethics approval [1] 301629 0
15/10/2018
Approval date [1] 301629 0
05/11/2018
Ethics approval number [1] 301629 0
HREC/2018/QPCH/43981

Summary
Brief summary
Perioperative lignocaine infusions have significant benefits for patients undergoing major abdominal surgery in regards to analgesia, reduced opioid requirements, earlier return of normal bowel function and potentially even enhanced recovery and discharge after surgery. Currently there is significant heterogeneity in the various suggested lignocaine dosing regimens and a real paucity of evidence in regards to optimal dosing in the bariatric population.

As a result, despite the benefits of perioperative lignocaine infusions particularly in the bariatric population, clinicians cannot be confident about the efficacy and safety of currently suggested lignocaine infusion regimes in this population group. As a result our objective is to develop a pharmacokinetic model of lignocaine infusion including patients at the extremes of BMI and thus develop a regimen for bariatric patients that achieves safe but effective therapeutic dosing.
Trial website
N/A
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 87590 0
Dr Angela Tognolini
Address 87590 0
C/O RBWH Anaesthetic Department
Royal Brisbane and Women's Hospital
Cnr of Bowen Bridge Road and Butterfield Street
Herston
Queensland
4029
Country 87590 0
Australia
Phone 87590 0
+61 7 36468111
Fax 87590 0
Email 87590 0
[email protected]
Contact person for public queries
Name 87591 0
Ms Lizanne Dagleish
Address 87591 0
C/O RBWH Anaesthetic Research Department
Royal Brisbane and Women's Hospital
Cnr of Bowen Bridge Road and Butterfield Street
Herston
Queensland
4029
Country 87591 0
Australia
Phone 87591 0
+61 7 36468111
Fax 87591 0
Email 87591 0
[email protected]
Contact person for scientific queries
Name 87592 0
Dr Angela Tognolini
Address 87592 0
C/O RBWH Anaesthetic Department
Royal Brisbane and Women's Hospital
Cnr of Bowen Bridge Road and Butterfield Street
Herston
Queensland
4029
Country 87592 0
Australia
Phone 87592 0
+61 7 36468111
Fax 87592 0
Email 87592 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
This is a pharmacokinetic trial for lignocaine infusions in the bariatric population as such the collected data is deidentified and pooled making each individual patient's data on its own irrelevant to the overall outcome.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
4851Study protocol  [email protected]



Results publications and other study-related documents

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