Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000832077
Ethics application status
Approved
Date submitted
30/09/2010
Date registered
5/10/2010
Date last updated
5/10/2010
Type of registration
Prospectively registered

Titles & IDs
Public title
Continuous Local Anaesthetic Wound Infiltration in Hepatobiliary Surgery - A Comparison with Placebo
Scientific title
In hepatobiliary surgical patients, does the use of continuous local anaesthetic wound infiltration compared with placebo wound infiltration improve patient outcomes in terms of better analgesia, reduced opiate consumption and reduced opiate side effects
Secondary ID [1] 252798 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Post-hepatobiliary surgery 258300 0
Condition category
Condition code
Anaesthesiology 258494 258494 0 0
Pain management
Surgery 258495 258495 0 0
Other surgery
Oral and Gastrointestinal 258509 258509 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
'Painbuster' wound infiltration device infusing local anaesthetic agent (0.2% Ropivacaine at rate of 4ml / hour) into surgical wounds for a 48 hour period post-operatively
Intervention code [1] 257323 0
Treatment: Devices
Intervention code [2] 257337 0
Treatment: Drugs
Comparator / control treatment
'Painbuster' wound infiltration device infusing placebo (normal saline at rate of 4ml / hour)) into surgical wounds for a 48 hour period post-operatively
Control group
Placebo

Outcomes
Primary outcome [1] 259329 0
Improved visual analogue pain scores when compared with placebo
Timepoint [1] 259329 0
First 48 hours post-operative (assessed at 1, 2, 6, 12, 18, 24, 30, 36, 42 and 48 hours)
Secondary outcome [1] 265779 0
Reduced opiate consumption as measured by total dose required by patient-controlled analgesia (PCA) machine
Timepoint [1] 265779 0
First 48 hours post-operative (assessed at 1, 2, 6, 12, 18, 24, 30, 36, 42 and 48 hours)
Secondary outcome [2] 265780 0
Reduced opiate side effects (eg. sedation, nausea and vomiting) using our hospital's Acute Pain Service patient-based numerical rating scale
Timepoint [2] 265780 0
First 48 hours post-operative (assessed at 1, 2, 6, 12, 18, 24, 30, 36, 42 and 48 hours)

Eligibility
Key inclusion criteria
1. Undergoing elective open hepatobiliary surgical procedure
2. American Society of Anaesthesiologists (ASA) physical status I, II or III
3. Physically and mentally able to use patient-controlled analgesia (PCA) machine
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Contraindication or known allergy to local anaesthetic drug
2. Preoperative cognitive dysfunction
3. Preoperative diagnosis of chronic pain or opiate tolerance

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



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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/11/2010
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] 257762 0
Self funded/Unfunded
Name [1] 257762 0
Country [1] 257762 0
Primary sponsor type
Individual
Name
Dr Lauren Radford
Address
Department of Anaesthesia
Princess Alexandra Hospital
Ipswich Road
Woolloongabba Qld 4102
Country
Australia
Secondary sponsor category [1] 256974 0
Individual
Name [1] 256974 0
Dr Peter Moran
Address [1] 256974 0
Department of Anaesthesia
Princess Alexandra Hospital
Ipswich Road
Woolloongabba Qld 4102
Country [1] 256974 0
Australia
Secondary sponsor category [2] 256975 0
Individual
Name [2] 256975 0
Dr Pal Sivalingam
Address [2] 256975 0
Department of Anaesthesia
Princess Alexandra Hospital
Ipswich Road
Woolloongabba Qld 4102
Country [2] 256975 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259805 0
Metro South Health Service District Human Research Ethics Committee
Ethics committee address [1] 259805 0
Ethics committee country [1] 259805 0
Date submitted for ethics approval [1] 259805 0
Approval date [1] 259805 0
Ethics approval number [1] 259805 0
HREC/10/QPAH/82

Summary
Brief summary
The aim of this project is to see whether continuous local anaesthetic wound infiltration for 48 hours post-operatively is useful in hepatobiliary surgical procedures in terms of:
1. Better pain relief
2. Reduced opiate consumption via patient-controlled analgesia (PCA) regime
3. Reduced opiate side effects (eg. nausea and vomiting, sedation, itch)

All patients enrolled would have a continuous wound infiltration catheter with a local anaesthetic pump device attached, as well as an opioid-continaing PCA machine. The contents of this pump device would be randomised to contain either local anaesthetic agent or normal saline (placebo). The wound infiltration catheter and infusion pump would remain for 48 hours post-operatively, and the PCA would remain available to each patient as long as clinically required. Each patient would be reviewed post-operatively as per our normal Acute Pain Service (APS) practice, and each patient would have regular observations performed and recorded as per normal protocol.

The data collected from each patient would include total opioid requirement via PCA, visual analogue scale (VAS) pain scores both at rest and with movement, and any side effects possibly related to local anaesthetic agents or infusion pump catheters.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31721 0
Address 31721 0
Country 31721 0
Phone 31721 0
Fax 31721 0
Email 31721 0
Contact person for public queries
Name 14968 0
Catherine Jowett
Address 14968 0
Department of Anaesthesia
Princess Alexandra Hospital
Ipswich Road
Woolloongabba QLD 4102
Country 14968 0
Australia
Phone 14968 0
+ 61 7 3176 2111
Fax 14968 0
Email 14968 0
Catherine_Jowett@health.qld.gov.au
Contact person for scientific queries
Name 5896 0
Dr Lauren Radford
Address 5896 0
Department of Anaesthesia
Princess Alexandra Hospital
Ipswich Road
Woolloongabba QLD 4102
Country 5896 0
Australia
Phone 5896 0
+ 61 7 3176 2111
Fax 5896 0
Email 5896 0
Lauren_Radford@health.qld.gov.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.