Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000439448
Ethics application status
Approved
Date submitted
9/08/2007
Date registered
29/08/2007
Date last updated
7/09/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
Efficacy of a 96hr duration local anaesthesia (l-bupivacaine) infusion using PainBuster device at the incision site compared with saline controls for post-operative pain management against a background of narcotic analgesia, following open or laparoscopic abdominal surgery.
Scientific title
Colorectal surgical patients treated with Chirocaine infusion versus saline at surgical site, and demands/usage of PCA narcotic analgesic and VAS score.
Secondary ID [1] 263001 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Post-operative pain management 2233 0
Condition category
Condition code
Surgery 2325 2325 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The aim is to test whether continuous local anaesthetic infusion (0.5% l-bupivacaine at 5ml/h for 0-48hr and 2ml/h for 48-96h post-op) using a commercial infiltration device can minimise, or eliminate, the need for narcotic analgesia following abdominal open or laparoscopic surgery. The potential benefits to the patient include earlier mobilisation, minimisation or averting the side-effects from narcotics (a particular issue in elderly patients following abdominal surgery), and shorter length-of-stay.
Intervention code [1] 1943 0
Treatment: Drugs
Comparator / control treatment
saline placebo infusion, double-blind
Control group
Placebo

Outcomes
Primary outcome [1] 3221 0
Pain management measured by (a) reduction in demands and usage of narcotic available using patient-controlled analgesic (PCA) device, and (b) visual analogue pain scores in patients on local anaesthetic infusion compared with saline/placebo controls
Timepoint [1] 3221 0
pain scores and PCA usage recorded 12 hourly for 96 hours post-op
Secondary outcome [1] 5375 0
patient satisfaction, mobilisation, return normal bowel function, would infection, length of hospital stay, adverse effects from local anaesthetic, unbound l-bupivacaine concentrations throughout infusion period
Timepoint [1] 5375 0
wound sterility, drug conc, pain scores determined 12hrly
Satisfaction at discharge and followup

Eligibility
Key inclusion criteria
Able to give informed consent
ASA Score <4 (ie., level 1, 2 or 3)
Normal to mildly elevated biochemical indices of renal and/or hepatic function
Mental status of the patient should be considered and included only if in the opinion of the surgeon and other attended medical staff, that the patient is capable of giving informed consent and would be capable of complying with the reasonable instructions to allow the study to progress
Smokers are admissible, and other drugs/medicines normally taken, other than those specified below
Minimum age
18 Years
Maximum age
90 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Pregnancy.
ASA Score >4 (ie., level 4, 5)
Moderate to severely elevated indices of renal and/or hepatic function, and patients with dementia
Taking drugs known to influence l-bupivacaine kinetics (CYP1A2 or CYP3A inhibitor/inducers; fluvoxamine, quinoline antibacterials, “conazole” antifungals)
Taking drugs that may affect pain perception [narcotics (including codeine containing preparations), tricyclic antidepressants, chronic pain killers, anti-epileptic drugs also used in pain therapy)
Patients receiving epidural anaesthesia
Known allergy to l-bupivacaine or fentanyl

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
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/09/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
81
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 208 0
5000 numbers

Funding & Sponsors
Funding source category [1] 2492 0
Self funded/Unfunded
Name [1] 2492 0
Raymond Morris
Country [1] 2492 0
Australia
Funding source category [2] 2493 0
Commercial sector/Industry
Name [2] 2493 0
Surgical Synergies
Country [2] 2493 0
Australia
Primary sponsor type
Hospital
Name
The Queen Elizabeth Hospital
Address
28 Woodville Rd
Woodville SA 5011
Country
Australia
Secondary sponsor category [1] 2261 0
University
Name [1] 2261 0
University of Adelaide
Address [1] 2261 0
North Tce
Adelaide SA 5000
Country [1] 2261 0
Australia
Other collaborator category [1] 2 0
University
Name [1] 2 0
Mr Peter Hewett
Address [1] 2 0
Dept of Surgery
University of Adelaide
TQEH
Woodville SA 5011
Country [1] 2 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 4389 0
Ethics of Human Research Committee
Ethics committee address [1] 4389 0
Ethics committee country [1] 4389 0
Australia
Date submitted for ethics approval [1] 4389 0
Approval date [1] 4389 0
01/12/2006
Ethics approval number [1] 4389 0
2008006

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

Contacts
Principal investigator
Name 27972 0
Address 27972 0
Country 27972 0
Phone 27972 0
Fax 27972 0
Email 27972 0
Contact person for public queries
Name 11129 0
Raymond Morris
Address 11129 0
Clinical Pharmacology
TQEH
Woodville Rd
Woodville SA 5011
Country 11129 0
Australia
Phone 11129 0
61882226753
Fax 11129 0
61882226033
Email 11129 0
ray.morris@health.sa.gov.au
Contact person for scientific queries
Name 2057 0
Raymond Morris
Address 2057 0
Clinical Pharmacology
TQEH
Woodville Rd
Woodville SA 5011
Country 2057 0
Australia
Phone 2057 0
61882226753
Fax 2057 0
61882226033
Email 2057 0
ray.morris@health.sa.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.