Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000603617
Ethics application status
Approved
Date submitted
25/09/2005
Date registered
5/10/2005
Date last updated
12/08/2024
Date data sharing statement initially provided
12/08/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Use of a local anaesthetic wound infusion to reduce morphine requirements following major abdominal surgery
Scientific title
Use of a local anaesthetic wound infusion to reduce morphine requirements following major abdominal surgery
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pain 732 0
Condition category
Condition code
Other 810 810 0 0
Conditions of unknown or disputed aetiology (such as chronic fatigue syndrome/myalgic encephalomyelitis)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Use of ropivacaine via Stryker(R) Pain Pump system for 48 hours post-op to decrease the amount of PCA morphine required following major abdominal surgery requiring midline laparotomy.
Comparator / control treatment
Saline
Control group
Placebo

Outcomes
Primary outcome [1] 1038 0
Morphine PCA use
Timepoint [1] 1038 0
Measured at 4, 24, 48, 72 hours post-op
Secondary outcome [1] 1933 0
Pain Scores at rest
Timepoint [1] 1933 0
Measured at 4, 24, 48, 72 hours .
Secondary outcome [2] 1934 0
Coughing and sitting up Anti-emetic use Sedation scores.
Timepoint [2] 1934 0
Measured at 4, 24, 48, 72 hours .

Eligibility
Key inclusion criteria
American Society of Anesthesiology (ASA) physical status 1, 2 or 3 patients undergoing elective major abdominal surgery via midline laparotomy at Geelong Hospital.
Minimum age
18 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Pregnant; weight <50kg; allergy to morphine or amide local anaesthetics; ASA physical status 4; severe renal disease ( eGFR < 40ml/min ); significant hepatic impairment; severe respiratory disease (FEV1 < 1.0 l) cognitive impairment or a history of chronic opioid use. Furthermore, patients may be excluded from the trial immediately post-operatively if they meet any of the following criteria: patients who remain intubated post-operatively; post-operative renal or hepatic failure; morphine intolerance or major surgical complications requiring a return to theatre such as sepsis, bleeding or anastomotic breakdown.

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)
Study numbers allocated on recruitment. Study medication allocated by pharmacy according to central randomisation schedule kept by them and contents blinded to patients and researchers.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
computer software generated ('minitab')
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
Stopped early
Data analysis
No data analysis planned
Reason for early stopping/withdrawal
Other reasons/comments
Other reasons
Trial was not completed as mode of surgery was changed at the recruiting hospital
Date of first participant enrolment
Anticipated
1/11/2005
Actual
1/11/2005
Date of last participant enrolment
Anticipated
Actual
1/05/2006
Date of last data collection
Anticipated
1/07/2006
Actual
Sample size
Target
60
Accrual to date
Final
30
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 896 0
Hospital
Name [1] 896 0
Department of Anaesthesia, Geelong Hospital
Country [1] 896 0
Australia
Primary sponsor type
Individual
Name
Dr Simon Tomlinson, Department of Anaestheisa, Geelong Hospital
Address
Country
Australia
Secondary sponsor category [1] 758 0
Individual
Name [1] 758 0
Dr Mark Shulman, Department of Anaestheisa, Geelong Hospital
Address [1] 758 0
Country [1] 758 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315918 0
BARWON HEALTH
Ethics committee address [1] 315918 0
Ethics committee country [1] 315918 0
Date submitted for ethics approval [1] 315918 0
30/09/2005
Approval date [1] 315918 0
30/10/2005
Ethics approval number [1] 315918 0
DON'T KNOW

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

Contacts
Principal investigator
Name 35745 0
Address 35745 0
Country 35745 0
Phone 35745 0
Fax 35745 0
Email 35745 0
Contact person for public queries
Name 9863 0
Dr Simon Tomlinson
Address 9863 0
Department of Anaesthesia
The Geelong Hospital
Ryrie St
Geelong VIC 3220
Country 9863 0
Australia
Phone 9863 0
+61 3 52267333
Fax 9863 0
Email 9863 0
[email protected]
Contact person for scientific queries
Name 791 0
Dr Simon Tomlinson
Address 791 0
Department of Anaesthesia
The Geelong Hospital
Ryrie St
Geelong VIC 3220
Country 791 0
Australia
Phone 791 0
+61 3 52267333
Fax 791 0
Email 791 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
Data no longer available


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.