Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000779673
Ethics application status
Approved
Date submitted
30/11/2005
Date registered
7/12/2005
Date last updated
7/12/2005
Type of registration
Prospectively registered

Titles & IDs
Public title
Does intra-operative intravenous lignocaine decrease post-operative opiate requirements in laparoscopic bowel resection?
Scientific title
Does intra-operative intravenous lignocaine decrease post-operative opiate requirements in laparoscopic bowel resection?
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pain 935 0
Condition category
Condition code
Oral and Gastrointestinal 1005 1005 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The initial dose of Lignocaine will be administered 5 minutes pre-induction. The infusion will run for the duration of the anaesthetic. This may vary from 60-300 minutes depending upon the duration of surgery.
Intervention code [1] 779 0
Diagnosis / Prognosis
Comparator / control treatment
Placebo will be used instead of Lignocaine. The initial dose of placebo will be administered 5 minutes pre-induction. The infusion will run for the duration of the anaesthetic. This may vary from 60-300 minutes depending upon the duration of surgery.
Control group
Placebo

Outcomes
Primary outcome [1] 1342 0
Total amount of opiate used in milligrams
Timepoint [1] 1342 0
Total will be calculated at 72 hours.
Primary outcome [2] 1343 0
Amount of opioid used
Timepoint [2] 1343 0
Primary outcome [3] 1344 0
Pain scores
Timepoint [3] 1344 0
Secondary outcome [1] 2386 0
Time to return of bowel function and dicharge to home.
Timepoint [1] 2386 0

Eligibility
Key inclusion criteria
Laparoscopic bowel surgery, laparoscopically assisted bowel resection.
Minimum age
18 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Laparotomy.

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/01/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
80
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1102 0
Self funded/Unfunded
Name [1] 1102 0
Country [1] 1102 0
Primary sponsor type
Individual
Name
christopher scarff
Address
Country
Australia
Secondary sponsor category [1] 969 0
None
Name [1] 969 0
nil
Address [1] 969 0
Country [1] 969 0

Ethics approval
Ethics application status
Approved

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

Contacts
Principal investigator
Name 35744 0
Address 35744 0
Country 35744 0
Phone 35744 0
Fax 35744 0
Email 35744 0
Contact person for public queries
Name 9968 0
Christopher Scarff
Address 9968 0
St Vincent's Hospital
41 Victoria Pde
Fitzroy VIC 3065
Country 9968 0
Australia
Phone 9968 0
+61 3 92882211
Fax 9968 0
Email 9968 0
scarffch@svhm.org.au
Contact person for scientific queries
Name 896 0
Christopher Scarff
Address 896 0
St Vincent's Hospital
41 Victoria Pde
Fitzroy VIC 3065
Country 896 0
Australia
Phone 896 0
+61 3 92882211
Fax 896 0
Email 896 0
scarffch@svhm.org.au

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.