Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000347662
Ethics application status
Approved
Date submitted
8/09/2005
Date registered
9/09/2005
Date last updated
19/01/2006
Type of registration
Retrospectively registered

Titles & IDs
Public title
Continuous infusion of local anaesthetic in the control of pain following colorectal surgery
Scientific title
Continuous infusion of local anaesthetic in the control of pain following colorectal surgery
Secondary ID [1] 145 0
02-16-06-03
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Post operative pain following a laparotomy for colorectal surgery 441 0
Condition category
Condition code
Anaesthesiology 514 514 0 0
Anaesthetics
Anaesthesiology 515 515 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
To determine whether continous local anaesthetic, ie. ropivacaine 1% (Naropin - produced by AstroZeneca) via a dual catheter PainBuster Soaker Pain Management System (produced by I-Flow) is a more effective form of post operative analgesia compared to traditional analgesias for midline incisions following major colorectal resections. The PainBuster Soaker System is tested in a randomised double blinded control study where participants either receive ropivacaine 1% or Saline in their PainBuster Device for the first three days. Both groups also receive a Morphine PCA, Tramadol, Ketorolac and Panadol.
Intervention code [1] 405 0
Treatment: Devices
Comparator / control treatment
Control group
Placebo

Outcomes
Primary outcome [1] 586 0
To evaluate if there is a statistically significant difference in pain scores and morphine utilisation in patients during the first three days post-operatively, as a measure of the effectiveness of the PainBuster Soaker Pain Management System.
Timepoint [1] 586 0
Secondary outcome [1] 1239 0
The complications of morphine
Timepoint [1] 1239 0
Secondary outcome [2] 1240 0
NSAIDs
Timepoint [2] 1240 0
Secondary outcome [3] 1241 0
Prolonged bed rest and local anaesthetic infusions.
Timepoint [3] 1241 0
Secondary outcome [4] 1242 0
Also the time it takes for patients to ambulate, the return of bowel function and the length of stay.
Timepoint [4] 1242 0
The time period being looked at is determined by the patient's length of stay.

Eligibility
Key inclusion criteria
Undergoing open colorectal surgery (excluding abdomino-perineal resections) and that there is written informed consent.
Minimum age
18 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Allergies to lignocaine or ropivacaine, true allergy to morphine, epidural or intrathecal infusions, emergency surgery, and if the patient is mentally or legally incapacitated or if the have a prior history of altered mental state.

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)
Ropivacaine was provided to an external third party who specialises in sterile phrmaceutical setups (Baxter). Baxter filled Luer lock syringes with either ropivacaine 1% or saline. The syringes were not marked which solution they had. Rather, they were allocated a number from 1 to 300 based on a computer generated list which randomised patient numbers to the two different treatments. The syringes were then provided to the investigators. The trial will not be unblinded until it's completion. Finally patients are allocated a number in consecutive order as they enter a trial. Based on the computer generated randomisation list, this will determine if they receive ropivacaine or normal saline.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A radomization list was computer generated allocating consecutive numbers between 1 and 300 to be either LA or normal saline
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
6/12/2004
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
300
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 575 0
Charities/Societies/Foundations
Name [1] 575 0
Mazda Foundation
Country [1] 575 0
Funding source category [2] 576 0
Other
Name [2] 576 0
Cabrini Clinical Education and Research Institute
Country [2] 576 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Mazda Foundation - Private Bag 40, Mount Waverley BC, Vic 3149
Address
Country
Australia
Secondary sponsor category [1] 466 0
University
Name [1] 466 0
Cabrini Clinical Education and Research Institue in conjuction with Cabrini Monash University Department of Surgery.
Address [1] 466 0
183 Wattletree Road, Malvern, Vic 3144
Country [1] 466 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 1597 0
Cabrini Human Research Ethics Committee (HREC)
Ethics committee address [1] 1597 0
Ethics committee country [1] 1597 0
Australia
Date submitted for ethics approval [1] 1597 0
Approval date [1] 1597 0
Ethics approval number [1] 1597 0
Ethics committee name [2] 1598 0
Monash University Standing Committee on Ethics and Research involving Humans (SCERH)
Ethics committee address [2] 1598 0
Ethics committee country [2] 1598 0
Australia
Date submitted for ethics approval [2] 1598 0
Approval date [2] 1598 0
Ethics approval number [2] 1598 0

Summary
Brief summary
To determine if there is a better and safer option for pain relief following laparotomies for colorectal surgery, by using a continuous infusion of local anaesthetic into the wound.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35255 0
Address 35255 0
Country 35255 0
Phone 35255 0
Fax 35255 0
Email 35255 0
Contact person for public queries
Name 9594 0
Dr. Jennifer Chong
Address 9594 0
c/o Cabrini Hospital
Suite 20
183 Wattletree Road
Malvern VIC 3144
Country 9594 0
Australia
Phone 9594 0
+61 3 95081651
Fax 9594 0
+61 3 95081657
Email 9594 0
[email protected]
Contact person for scientific queries
Name 522 0
Professor Adrian Polglase
Address 522 0
c/o Cabrini Hospital
Suite 20
183 Wattletree Road
Malvern VIC 3144
Country 522 0
Australia
Phone 522 0
+61 3 95098233
Fax 522 0
+61 3 95090812
Email 522 0
[email protected]

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.