Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000413628
Ethics application status
Approved
Date submitted
9/09/2005
Date registered
15/09/2005
Date last updated
9/04/2008
Type of registration
Retrospectively registered

Titles & IDs
Public title
A preliminary safety study comparing the concentration of a local anaesthetic absorbed into the blood (when trickling near the surgical site for 96hours after surgery) to published threshold for toxicity
Scientific title
Pilot study investigating the safety & efficacy of 96hr duration local anaesthesia (ropivacaine) infused at the incision site for post-operative pain management following right hemicolectomy
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Bowel Cancer Surgery 521 0
Condition category
Condition code
Cancer 598 598 0 0
Bowel - Anal
Cancer 599 599 0 0
Bowel - Back passage (rectum) or large bowel (colon)
Cancer 600 600 0 0
Bowel - Small bowel (duodenum and ileum
Anaesthesiology 601 601 0 0
Pain management
Surgery 602 602 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Pain management with local anaesthetic (ropivacaine) continuous infusion during- & post-op using ON-Q pain Buster device.
Intervention code [1] 441 0
Treatment: Devices
Comparator / control treatment
there was no control arm in this pilot study
Control group
Uncontrolled

Outcomes
Primary outcome [1] 696 0
Safety of LA
Timepoint [1] 696 0
serial blood sampling 0-96hr of local anaesthetic administration
Secondary outcome [1] 1434 0
Efficacy (measured by 12hrly pain scores using Visual Analogue Scales; and also by frequency of using Patient Controlled Analgesia with narcotic).
Timepoint [1] 1434 0
Over the 4-5 days of the admission.
Secondary outcome [2] 1435 0
Infection rate (scored by the appearance, duration, organism, and treatment of infection at the surgical site).
Timepoint [2] 1435 0
During the 4-day treatment with the PainBuster.

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 functionMental 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 progressSmokers are admissible, and other drugs/medicines normally taken, other than those specified below. Patient with no previous abdominal surgery.
Minimum age
18 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Failure to provide written informed consentUnder 18 years of agePregnancy. Clearly pregnant females with bowel cancer would be a complication requiring specific clinical management, and so not appropriate for this pilot studyASA Score >4 (ie., level 4, 5)Moderate to severely elevated indices of renal and/or hepatic function, and patients with dementiaTaking drugs known to influence ropivacaine 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, regular non-steroidal use including COX-2 inhibitors, chronic pain killers, anti-epileptic drugs also used in pain therapy)Larger tumor size (>8cm)Previous abdominal surgery, including laparotomyKnown allergy to ropivacaine 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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 3 / Phase 4
Type of endpoint/s
Safety
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
2/01/2005
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
10
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 655 0
Commercial sector/Industry
Name [1] 655 0
untied supporting grant from Astra Zeneca Pharmaceuticals (Australia)
Country [1] 655 0
Australia
Funding source category [2] 656 0
Charities/Societies/Foundations
Name [2] 656 0
TQEHRF
Country [2] 656 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
TQEH Research Foundation
Address
50 Woodville Rd
Woodville SA 5011
Country
Australia
Secondary sponsor category [1] 548 0
Commercial sector/Industry
Name [1] 548 0
Astra Zeneca
Address [1] 548 0
P.O. Box 131
North Ryde NSW 1670
Country [1] 548 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 1798 0
The Queen Elizabeth Hospital
Ethics committee address [1] 1798 0
28 Woodville Rd
Woodville SA 5011
Ethics committee country [1] 1798 0
Australia
Date submitted for ethics approval [1] 1798 0
Approval date [1] 1798 0
13/01/2005
Ethics approval number [1] 1798 0
2004142

Summary
Brief summary
This is a pilot study to consider whether post-operative pain management (following right hemicolectomy surgery using a lateral transverse incision) with continuous ropivacaine infusion using an elastomeric infusion pump (ON-Q Painbusterÿ¿??ÿ¿?ÿ¿ÿ®) for 96hr (rather than epidural) is safe, based on the margin between steady-state plasma ropivacaine concentrations attained (in particular, the unbound concentrations) and the systemic toxicity threshold(s). Whilst this device and local anaesthetic approach are currently used for post-op pain management, common usage in Australia is currently limited to 48-hr post-op.
Trial website
Trial related presentations / publications
119. Corso OH, Karatassas A, Hewett PJ, Morris RG. Pilot study examining safety of extended ropivacaine infusion into the incision-site following right hemicolectomy. Proc Aust Soc Clin Exp Pharmacol Toxicol, 11:1-24. 2005
112. Corso OH, Morris RG, Hewett PJ, Karatassas A. Safety of 96-hour incision-site continuous infusion of ropivacaine for post-operative analgesia following bowel-cancer resection. Ther Drug Monit 29:57-63. 2007
Public notes

Contacts
Principal investigator
Name 35143 0
Address 35143 0
Country 35143 0
Phone 35143 0
Fax 35143 0
Email 35143 0
Contact person for public queries
Name 9630 0
Mr Peter Hewett
Address 9630 0
Department of Surgery
The Queen Elizabeth Hospital
28 Woodville Rd
Woodville SA 5011
Country 9630 0
Australia
Phone 9630 0
+61 8 82226284
Fax 9630 0
+61 8 82226033
Email 9630 0
[email protected]
Contact person for scientific queries
Name 558 0
Associate Professor Ray Morris
Address 558 0
Clinical Pharmacology
The Queen Elizabeth Hospital
28 Woodville Rd
Woodville SA 5011
Country 558 0
Australia
Phone 558 0
+61 8 82226753
Fax 558 0
+61 8 82226033
Email 558 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.