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Trial registered on ANZCTR


Registration number
ACTRN12609000409279
Ethics application status
Approved
Date submitted
14/05/2009
Date registered
3/06/2009
Date last updated
3/06/2009
Type of registration
Retrospectively registered

Titles & IDs
Public title
Does epidural analgesia affect outcome after lower limb bypass surgery?
Scientific title
A Comparison of the Effects of Epidural Versus Parenteral Analgesia Techniques on Outcome Following Lower Limb Vascular Bypass Surgery
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Peripheral Vascular Disease 4780 0
Condition category
Condition code
Surgery 237112 237112 0 0
Other surgery
Anaesthesiology 237122 237122 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Postoperative Epidural analgesia.
Lumbar epidural anaesthesia provided intraoperatively by catheter is to be continued postoperatively by continuous infusion using Ropivacaine 0.2% at the minimal rate required by titration to provide effective analgesia without producing side effects such as hypotension or excessive lower limb motor block. This is to be continued for 72 hours from the completion of surgery. All patients to receive aspirin 100mg daily. After 72 hours patients to convert to simple oral analgesia.
Intervention code [1] 4556 0
Treatment: Other
Comparator / control treatment
Postoperative Parenteral Analgesia.
Lumbar epidural analgesia provided intraoperatively is ceased at the completion of surgery and the epidural catheter removed. Ongoing analgesia thereafter is to be provided using combination oral and parenteral agents on "as required" basis according to ward practice. Agents used include morphine 5-10mg intramuscularly or subcutaneously 3 to 4 hourly, Oxycodone 5-10mg orally 4 to 6 hourly, Paracetamol 0.5-1g orally 6 hourly. All patients to receive aspirin 100mg daily.
Control group
Active

Outcomes
Primary outcome [1] 237949 0
Vascular Graft Patency.
Graft surveillance is performed at least 4 hourly throughout the hospital admission by assessment of pulses and, in the absence of a pulse, Doppler ultrasound. Graft failure is defined as the requirement for thrombectomy, regrafting or unexpected amputation.
Method of assessment includes patient history review for the duration of inpatient admission. Following discharge, histories are reviewed for information from outpatient appointments where available. Where this is incomplete or unavailable, patients and/or their primary care physician are contacted by telephone call.
Timepoint [1] 237949 0
30 days, 6 months from the day of surgery; graft complications within 30 days define early graft failure; graft complications between 30 days and 6 months define late graft failure.
Secondary outcome [1] 242045 0
Any other postoperative medical or surgical morbidity, defined as presentation of a new illness or exacerbation of a pre-existing illness.
Method of assessment includes patient history review for the duration of inpatient admission. Following discharge, histories are reviewed for information from outpatient appointments where available. Where this is incomplete or unavailable, patients and/or their primary care physician are contacted by telephone call.
Timepoint [1] 242045 0
30 days, 6 months from the day of surgery; morbidity within 30 days defines early morbidity; morbidity between 30 days and 6 months defines late morbidity.

Eligibility
Key inclusion criteria
Lower limb arterial bypass surgery where the distal vascular anastomosis is below the level of knee joint
Minimum age
No limit
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Contraindications to epidural analgesia such as coagulopathy, neurological conditions affecting the lower limbs, orthopaedic or septic complications at proposed epidural insertion site; intolerance of parenteral analgesics

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)
Sequentially enrolled elective surgical patients, group allocation concealed with opaque envelope
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Compute generated permuted blocks
Masking / blinding
Open (masking not 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
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 4958 0
Other Collaborative groups
Name [1] 4958 0
Australian and New Zealand College of Anaesthetists
Address [1] 4958 0
630 St.Kilda Rd., Melbourne 3000
Country [1] 4958 0
Australia
Primary sponsor type
Hospital
Name
St. Vincent's Hospital Melbourne
Address
41 Victoria Pde.
Fitzroy
Vic. 3065
Country
Australia
Secondary sponsor category [1] 4483 0
None
Name [1] 4483 0
Address [1] 4483 0
Country [1] 4483 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 7058 0
St. Vincent's Hospital Melbourne Research and Ethics Committee
Ethics committee address [1] 7058 0
41 Victoria Pde.
Fitzroy
Vic. 3065
Ethics committee country [1] 7058 0
Australia
Date submitted for ethics approval [1] 7058 0
Approval date [1] 7058 0
05/01/1999
Ethics approval number [1] 7058 0
HREC-A 78/98

Summary
Brief summary
Epidural anaesthesia has a mitigating influence on adverse metabolic effects that may influence the outcome from surgery. This trial was designed to investigate whether extending epidural analgesia into the postoperative period improves outcome from high risk vascular bypass surgery
Trial website
Trial related presentations / publications
Australian and New Zealand College of Anaesthetists (ANZCA) Annual Scientific Meeting Aukland NZ 2005;
St. Vincent's Hospital Melbourne 2005
Public notes

Contacts
Principal investigator
Name 29604 0
Address 29604 0
Country 29604 0
Phone 29604 0
Fax 29604 0
Email 29604 0
Contact person for public queries
Name 12851 0
Dr Desmond McGlade
Address 12851 0
Department of Anaesthesia
St. Vincent's Hospital Melbourne
PO Box 2900
Fitzroy Vic. 3065
Country 12851 0
Australia
Phone 12851 0
613 92884253
Fax 12851 0
613 92884193
Email 12851 0
desmond.mcglade@svhm.org.au
Contact person for scientific queries
Name 3779 0
Dr Desmond McGlade
Address 3779 0
Department of Anaesthesia
St Vincent's Hospital Melbourne
PO Box 2900
Fitzroy Vic. 3065
Country 3779 0
Australia
Phone 3779 0
613 92884253
Fax 3779 0
613 92884193
Email 3779 0
desmond.mcglade@svhm.org.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary