Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611001005943
Ethics application status
Approved
Date submitted
20/09/2011
Date registered
20/09/2011
Date last updated
21/09/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
Can certain anaesthesia medications & techniques provide additional benefits after cancer surgery apart from pain relief and speed of recovery from that surgery (LIPO trial - Lignocaine infusion given peri-operatively)
Scientific title
Can anaesthetic technique in the form of peri-operative lignocaine infusion to blunt surgical stress response have additional benefits in long term outcome following primary cancer surgery
Secondary ID [1] 263074 0
Nil
Universal Trial Number (UTN)
Trial acronym
LIPO (Lignocaine Infusion Peri-operatively)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non-metastatic cancers in patients undergoing primary cancer surgery 270811 0
Condition category
Condition code
Cancer 271002 271002 0 0
Any cancer
Anaesthesiology 271006 271006 0 0
Anaesthetics

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intra-operative lignocaine infusion. Replica of methodology from existing study, specifically Kuo et al, British Journal of Anaesthesia, 97 (5): 640–6 (2006): 2mg/kg over 15 mins, followed by 3mg/kg/hr IV. Continued intra-op and 30 mins post op. Intraoperative top-up fentanyl and post operative morphine patient controlled analgesia (PCA) if required.

Additional resource [ANZCTR no: 12609001073291]
& Annals of Surgery - Volume 246, Number 2, August 2007 page 192

- slight modification in methodology & dose
Intervention code [1] 269425 0
Treatment: Drugs
Comparator / control treatment
Saline. Intraoperative top-up fentanyl and post operative morphine patient controlled analgesia (PCA) if required.
Control group
Placebo

Outcomes
Primary outcome [1] 279666 0
Tumour recurrence. Clinical assessments and relevant biochemical markers specific to each cancer type.
Timepoint [1] 279666 0
1 year, 3 years
Secondary outcome [1] 294156 0
Mortality. Death register investigation, phone calls to prompt clinical assessment by surgeons, note retrieval to determine surgical outcome. Biochemical markers relevant to the specific cancer type.
Timepoint [1] 294156 0
1 year, 3 years
Secondary outcome [2] 294157 0
Quality of hospital stay, including pain, DVT, and other miscellanous surgical complications. Recording of pain medication used, pain scores, length of stay, possible complications (free format)
Timepoint [2] 294157 0
Up to 1 week post operation

Eligibility
Key inclusion criteria
Non metastatic cancer requiring primary surgery:
Colectomy, nephrectomy, prostatectomy, hysterectomy, melanoma excision, mastectomy, cystectomy
Minimum age
40 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Metastases
ASA 4 and above
Diabetes
Concurrent pre-operative opioid analgesic use
Anti arrythmic drugs, arrythmogenic conditions
Hepatic or renal impairment
Pregnancy

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)
Patient leaflet to selected population.
If patient willing, anaesthetist to decide if patient elligible.
Central randomisation of drug packs by pharmacy within each subgroup (cancer type - ie each cancer type has 50% intervention vs placebo)
Drug packs matched to randomisation list, placed in temp storage by pharmacy in categories (per cancer type), obtained at random by anaesthetist on day of surgery from temp storage category and pack number recorded.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Double blinded, pharmacy generated centralised randomisation list by simple computer sequence generation.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/10/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
600
Accrual to date
Final
Recruitment outside Australia
Country [1] 3853 0
New Zealand
State/province [1] 3853 0

Funding & Sponsors
Funding source category [1] 269899 0
Self funded/Unfunded
Name [1] 269899 0
Dr Craig Surtees
Country [1] 269899 0
New Zealand
Primary sponsor type
Hospital
Name
Palmerston North Hospital
Address
c/o Anaesthetic Dept
50 Ruahine St
Palmerston North
4410
Country
New Zealand
Secondary sponsor category [1] 268911 0
None
Name [1] 268911 0
Address [1] 268911 0
Country [1] 268911 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 271870 0
Upper South A Regional Ethics Committee
Ethics committee address [1] 271870 0
Ethics committee country [1] 271870 0
New Zealand
Date submitted for ethics approval [1] 271870 0
Approval date [1] 271870 0
14/09/2011
Ethics approval number [1] 271870 0
URA/11/08/046

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33184 0
Address 33184 0
Country 33184 0
Phone 33184 0
Fax 33184 0
Email 33184 0
Contact person for public queries
Name 16431 0
Craig Surtees
Address 16431 0
c/o Anaesthetic Dept
50 Ruahine St
Palmerston North
4410
Country 16431 0
New Zealand
Phone 16431 0
+64 6 3569169
Fax 16431 0
Email 16431 0
surtees@rocketmail.com
Contact person for scientific queries
Name 7359 0
Craig Surtees
Address 7359 0
c/o Anaesthetic Dept
50 Ruahine St
Palmerston North
4410
Country 7359 0
New Zealand
Phone 7359 0
+64 6 3569169
Fax 7359 0
Email 7359 0
surtees@rocketmail.com

No information has been provided regarding IPD availability


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.