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Trial registered on ANZCTR


Registration number
ACTRN12618000754246
Ethics application status
Approved
Date submitted
11/04/2018
Date registered
4/05/2018
Date last updated
16/11/2023
Date data sharing statement initially provided
28/11/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Effect of Lignocaine Infusion in Colorectal Cancer Patient Immune Cells
Scientific title
A Double-Blind Randomised Placebo-Controlled Trial Assessing the Effect of Peri-Operative Intravenous Lignocaine and Post-Operative Lignocaine Neurovascular Plane Infusion on Natural Killer Cell Function in Laparoscopic Colorectal Cancer Surgery
Secondary ID [1] 294573 0
JHGIS12
Universal Trial Number (UTN)
Trial acronym
LICPIC Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
colon cancer 307354 0
Condition category
Condition code
Cancer 306461 306461 0 0
Bowel - Back passage (rectum) or large bowel (colon)
Inflammatory and Immune System 306462 306462 0 0
Other inflammatory or immune system disorders
Anaesthesiology 306463 306463 0 0
Pain management
Surgery 306464 306464 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Prior to surgery commencing, participants will be randomised to Treatment S or Treatment R. At commencement of anaesthesia the study drug will commence as an intravenous infusion of a 1% lignocaine infusion or placebo at a dose of 1.5mg per kg capped at a maximum weight of 100kg. This infusion will continue into recovery for 1 hour, then will be changed to an infusion of same rate via a catheter placed during the operative procedure into a muscular neurovascular plane in the abdominal wall. The infusion will continue for a maximum of 3 days post-operatively, there is no minumum duration for infusion. The specific duration will be determined by the post-operative recovery of the individual patient. The study drug will be prescribed on standard continous nerve block prescription charts which will be used to confirm compliance to study intervention.
Intervention code [1] 300865 0
Treatment: Drugs
Comparator / control treatment
0.9% sodium chloride solution
Control group
Placebo

Outcomes
Primary outcome [1] 305469 0
The composite primary outcome will be the difference in baseline natural killer cell function (cytotoxic and secretory) as measured by flow cytometry and phorbol 12-myristate 13-acetate (PMA) stimulation testing.
Timepoint [1] 305469 0
0 (baseline prior to any administration of medication for procedure), end of hour 1 in operating theatre and hour 2 in recovery, 24, 48 and 72 hours.
Secondary outcome [1] 345355 0
Post-operative analgesic consumption (MilliEquivalents of morphine) assessed by review of medical record.
Timepoint [1] 345355 0
daily for 3 days and total
Secondary outcome [2] 345357 0
Time (measured in whole days) until return of bowel function as defined as tolerance to solid intake for 24 hours (no vomiting) AND passage of stool whilst in hospital as recorded in the medical record (the day when both of those gut functions has occurred, ie if no vomiting occurs on day 2 and passage of stool occurs at day 3, then day 3 is the outcome time).
Timepoint [2] 345357 0
Whilst in hospital.
Secondary outcome [3] 345359 0
Mean length of hospital stay (in days)
Timepoint [3] 345359 0
till discharge
Secondary outcome [4] 345361 0
Incidence of post-operative surgical complications graded by the Clavien-Dindo Classification of Surgical Complications
Timepoint [4] 345361 0
up to day 30 post-operatively
Secondary outcome [5] 345362 0
Mean difference between groups as measured by serum c-reactive protein.
Timepoint [5] 345362 0
Daily until discharge
Secondary outcome [6] 345363 0
Incidence of toxic (greater than therapeutic normal range 1.5-5mg/L) serum lignocaine levels measure by direct assay
Timepoint [6] 345363 0
In hours from operation
-end of operation
-hour 1
-hour 2 in recovery
-24, 48 and 72 hours post-operatively
Secondary outcome [7] 346104 0
Mean difference between groups as measured by serum cortisol .
Timepoint [7] 346104 0
Daily until discharge
Secondary outcome [8] 368972 0
Plasma lignocaine concentration measured by Liquid Chromatography Mass Spectroscopy LCMS
Timepoint [8] 368972 0
0 (baseline prior to any administration of medication for procedure), end of hour 1 in operating theatre and hour 2 in recovery, 24, 48 and 72 hours.
Secondary outcome [9] 368973 0
Plasma Interleukin-6, Interleukin-2 and Interferon gamma concentration measured by Enzyme-Linked Immunosorbent Assay ELISA
Timepoint [9] 368973 0
0 (baseline prior to any administration of medication for procedure), end of hour 1 in operating theatre and hour 2 in recovery, 24, 48 and 72 hours.
Secondary outcome [10] 368974 0
Serum cortisol concentration measured by bead-based immunoassay
Timepoint [10] 368974 0
0 (baseline prior to any administration of medication for procedure), end of hour 1 in operating theatre and hour 2 in recovery, 24, 48 and 72 hours.
Secondary outcome [11] 368975 0
Plasma/Serum C Reactive Protein concentration
Timepoint [11] 368975 0
0 (baseline prior to any administration of medication for procedure), hour 2 in recovery, 24, 48 and 72 hours.

Eligibility
Key inclusion criteria
All patients with colorectal cancer undergoing elective or semi-elective laparoscopic colon resection at the John Hunter Hospital and Newcastle Private Hospital
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
a. are under 18 years of age, or
b. refuse or are unable to give written informed consent to participate in the study, or
c. have had previous abdominal surgery where there is a significant chance of the procedure not being able to be completed in a laparoscopic manner, based in the clinical judgement of the operating surgeon, or
d. have severe renal impairment or
e. receive an epidural, spinal or other neuroaxial anaesthetic as determined by the Anaesthetist on day of surgery, or
f. Have a planned stoma formation or
a. Have received neoadjuvant chemo-radiotherapy or have been on immunosuppressive agents in the preceding 8 weeks including glucocorticoids (not including inhaled steroids), antimetabolites, cytostatics (eg platinum compounds), antimetabolites (eg methotrexate, mercaptopurine, azathioprine, 5FU, anthracyclines, cytotoxic antibiotics eg bleomycin) , TNF bindng proteins (eg infliximab), drugs acting on immunophilins or
b. Have known stage 4 colorectal cancer disease
c. have known immunological disease including leukaemia or
d. have known allergy or adverse reaction to lignocaine or opioid drugs or
e. pregnant or lactating or
f. have a history of arrhythmia or long QT syndrome associated with the drugs used in this trial, or
g. Are taking regular opiate narcotics pre-operatively

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation
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
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
11/09/2018
Actual
11/09/2018
Date of last participant enrolment
Anticipated
Actual
20/09/2022
Date of last data collection
Anticipated
28/10/2022
Actual
4/11/2022
Sample size
Target
107
Accrual to date
Final
107
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 10626 0
John Hunter Hospital - New Lambton
Recruitment hospital [2] 12568 0
Newcastle Private Hospital - New Lambton Heights
Recruitment hospital [3] 21544 0
Calvary Mater Newcastle - Waratah
Recruitment postcode(s) [1] 22344 0
2305 - New Lambton
Recruitment postcode(s) [2] 24947 0
2305 - New Lambton Heights
Recruitment postcode(s) [3] 36451 0
2298 - Waratah

Funding & Sponsors
Funding source category [1] 299190 0
Hospital
Name [1] 299190 0
John Hunter Hospital
Country [1] 299190 0
Australia
Funding source category [2] 307310 0
Charities/Societies/Foundations
Name [2] 307310 0
Colorectal Surgical Society of Australia and New Zealand Foundation Pty Ltd
Country [2] 307310 0
Australia
Funding source category [3] 307311 0
Hospital
Name [3] 307311 0
John Hunter Hospital Anaesthesia Trust
Country [3] 307311 0
Australia
Funding source category [4] 307312 0
Hospital
Name [4] 307312 0
John Hunter Hospital Surgical Training Fund
Country [4] 307312 0
Australia
Primary sponsor type
Government body
Name
Hunter New England Local Health District
Address
Locked Bag 1
Hunter Region Mail Centre NSW 2310
Country
Australia
Secondary sponsor category [1] 298453 0
None
Name [1] 298453 0
NA
Address [1] 298453 0
Country [1] 298453 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300115 0
Huner New England Hman Research Ethics Committee
Ethics committee address [1] 300115 0
Locked Bag 1
New Lambton NSW 2305
Ethics committee country [1] 300115 0
Australia
Date submitted for ethics approval [1] 300115 0
28/03/2018
Approval date [1] 300115 0
03/05/2018
Ethics approval number [1] 300115 0
2018/ETH00049

Summary
Brief summary
The study aims to find out if giving local anaesthetic (a medication that numbs an area of the body) into the bloodstream and via small plastic tube placed during surgery into the abdomen will improve part of the immune system in patients undergoing surgery for colorectal cancer.

Who is it for?
You may be eligible to join this study if you aged 18 years or more and are scheduled to undergo a keyhole operation (laparoscopic surgery) for colorectal cancer to remove a section of the bowel (also known as colon).

Study details
Participants in this study will be randomly allocated (by chance) into one of two groups. Participants in one group will receive a local anaesthetic drug called Lignocaine infused directly into the bloodstream and also into the abdomen using a small plastic tube placed during surgery. Lignocaine is very commonly used to numb areas of skin or muscle before or during an operation. Importantly it has also been shown to help the natural killer cells (NKC) to destroy cancer cells. NKCs are a special type of white blood cell which recognises and destroys cancer cells. Participants in the other group will instead be given a placebo (salty water).
Participants will not know which group they are in.

All participants will be monitored for up to 30 days post-surgery in order to evaluate safety and also to see if the natural killer cells in the blood work better after lignocaine is used.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 51610 0
Prof Stephen Smith
Address 51610 0
Surgical Services
John Hunter Hospital
Locked Bag 1
Hunter Region Mail Centre NSW 2310
Country 51610 0
Australia
Phone 51610 0
+61 2 49236397
Fax 51610 0
Email 51610 0
[email protected]
Contact person for public queries
Name 51611 0
Rosemary Carroll
Address 51611 0
Surgical Services
John Hunter Hospital
Locked Bag 1
Hunter Region Mail Centre NSW 2310
Country 51611 0
Australia
Phone 51611 0
+61 2 49236397
Fax 51611 0
Email 51611 0
[email protected]
Contact person for scientific queries
Name 51612 0
Rosemary Carroll
Address 51612 0
Surgical Services
John Hunter Hospital
Locked Bag 1
Hunter Region Mail Centre NSW 2310
Country 51612 0
Australia
Phone 51612 0
+61 2 49236397
Fax 51612 0
Email 51612 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
Not HREC approved for this at time of initial application and approval. May be reviewed at a later.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.