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ISRCTN
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ISRCTN39571402
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ClinicalTrials.gov identifier
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Public title
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Influence of two local anaesthetic techniques on the survival of arteriovenous fistulas created for renal dialysis access
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Scientific title
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Influence of local and regional anaesthetic techniques on arteriovenous fistula access survival - a randomized controlled study
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Acronym
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N/A
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Serial number at source
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N/A
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Study hypothesis
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There is an increasing amount of evidence that shows arteriovenous fistulas created under a regional block (i.e. axillary brachial plexus block hence anaesthetizing the whole arm) tend to remain patent for longer.
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Lay summary
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Lay summary under review
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Ethics approval
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NRES Committee North East – Sunderland
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Study design
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Randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Surgical arteriovenous fistula for renal access dialysis
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Participants - inclusion criteria
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1. Patients referred for creation of a new radiocephalic or brachiocephalic fistula who consent to take part in the study and agree to have the procedure performed while conscious.
2. Aged 18 - 90
3. Male and female participants
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Participants - exclusion criteria
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1. Patients who require revision surgery.
2. Having had previous arteriovenous fistula surgery is not a contraindication to recruitment provided the new procedure is not revision surgery
3. Patients undergoing the procedure under General Anaesthetic
4. Known allergy to levobupivacaine (extremely rare)
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Anticipated start date
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01/01/2012
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Anticipated end date
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01/01/2014
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Status of trial
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Ongoing |
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Patient information material
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Not available in web format, please use the contact details below to request a patient information sheet
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Target number of participants
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220
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Interventions
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We are comparing two well established approaches to the creation of arteriovenous fistulas for renal access dialysis:
1. Arteriovenous fistula created under regional axillary block using levobupivacaine
2. Arteriovenous fistula created under local anaesthetic infiltration using levobupivacaine
Both groups will undergo Doppler assessment of their fistula at 8 weeks post-operatively to assess flow rates. This test is also undertyaken by patients not taking part in the trial, hence not trial specific. Follow up for trial purposes is 8 weeks.
Please note this trial is not a Clinical Trial of Investigational Medicinal Products (CTIMP) (Medicines and Healthcare products Regulatory Agency [MHRA] guidance)
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Primary outcome measure(s)
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Fistula Doppler flow rate measurement at eight weeks post operatively. This measurement is already performed on all arteriovenous fistulas as part of routine arteriovenous fistula management.
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Secondary outcome measure(s)
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1. A patient satisfaction survey pertaining to patient experience of the local/regional anaesthetic techniques, the surgical procedure and their overall hospital experience will be undertaken
2. A standardized and validated questionnaire using a 5 point Likert scale will be provided to patients following the procedure and we will ask them to complete it before they leave hospital
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Sources of funding
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Department of Vascular Surgery, Sunderland Royal Hospital (UK)
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Trial website
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Publications
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Contact name
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Mr
Andrew
Brown
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Address
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Sunderland Royal Hospital
Department of Vascular Surgery
Kayll Road
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City/town
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Sunderland
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Zip/Postcode
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SR4 7TP
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Country
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United Kingdom
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Tel
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+44 (0)191 565 6256
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Email
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andrew.brown@chsft.nhs.uk
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Sponsor
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City Hospitals Sunderland NHS Foundation Trust (UK)
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Address
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c/o Ms Michelle Ferguson
Directorate of General Surgery
Departmet of Vascular Surgery
Kayll Road
Tyne & Wear
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City/town
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Sunderland
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Zip/Postcode
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SR4 7TP
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Country
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United Kingdom
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Tel
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+44 (0)191 565 6256
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Email
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michelle.ferguson@chsft.nhs.uk
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Sponsor website:
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http://www.chsft.nhs.uk/
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Date applied
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27/11/2011
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Last edited
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18/01/2012
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Date ISRCTN assigned
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18/01/2012
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