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ISRCTN
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ISRCTN29107680
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ClinicalTrials.gov identifier
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Public title
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Perioperative Analgesia for Knee Arthroplasty (PAKA) - a pilot randomised trial
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Scientific title
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Acronym
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PAKA
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Serial number at source
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PAKA/PROTOCOL/V002
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Study hypothesis
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Peri-articular knee infiltration with Levobupivicaine 150mg, Morphine 10mg & Ketorolac 30mg reduces postoperative pain following primary total knee replacement compared with the current standard treatment of femoral nerve blockade
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Lay summary
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Ethics approval
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West Midlands Research Ethics Committee, REC Number: 10/H1208/37
Protocol number: PAKA/PROTOCOL/001 30 July 2010
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Study design
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Pilot single centre standard of care controlled trial double blinded pragmatic randomised 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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Muskuloskeletal, total knee arthroplasty, analgesia
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Participants - inclusion criteria
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All patients undergoing an elective primary unilateral total knee replacement (TKA) under the care of an orthopaedic consultant at University Hospitals Coventry and Warwickshire NHS Trust
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Participants - exclusion criteria
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1. Cognitive impairment, unable to complete questionnaire
2. Patients who lack capacity under the Mental Capacity Act 2005
3. Patients with pre-operative history of neruological abnormality in the ipsilateral leg e.g. history of stroke, neurogenic pain or previous nerve injury
4. Patients having spinal aneasthesia
5. Patients with specific contraindication to the analgesic agents used: Morphine, Ketorolac, Levobupivicaine
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Anticipated start date
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01/01/2010
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Anticipated end date
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31/12/2010
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Status of trial
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Completed |
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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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46
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Interventions
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Femoral nerve block using 30ml of Levobupivicaine 0.25% versus Peri-articular infiltration of multimodal agents consisting of 150mg of Levobupivacaine, 10mg Morphine and 30mg Ketorolac diluted in 0.9% saline to make a volume of 100ml
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Primary outcome measure(s)
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Visual Analogue Scale at 18 hours post operation
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Secondary outcome measure(s)
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Serum Levobupivacaine levels pre & post retransfusion
1. Functional assessment:
1.1. Straight leg raise
1.2. Mobility assessed bed to chair 18 & 48 hours post operatively
2. Oxford Knee Score 6 weeks post operatively
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Sources of funding
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Astra Tech (UK)
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Trial website
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Publications
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Contact name
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Mr
Matthew
Costa
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Address
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University Hospitals Coventry & Warwickshire
Clinical Sciences Building 1st Floor
Clinical Sciences Reseach Institute
Clifford Bridge Road
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City/town
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Coventry
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Zip/Postcode
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CV2 2DX
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Country
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United Kingdom
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Sponsor
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University of Warwick (UK)
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Address
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c/o Peter Hedges
Research Support Services
University House
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City/town
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Coventry
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Zip/Postcode
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CV4 8UW
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Country
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United Kingdom
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Sponsor website:
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http://www2.warwick.ac.uk/
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Date applied
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18/01/2011
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Last edited
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01/06/2011
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Date ISRCTN assigned
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01/06/2011
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