Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
PAKA/PROTOCOL/V002
Study information
Scientific title
Acronym
PAKA
Study hypothesis
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
Ethics approval
West Midlands Research Ethics Committee, REC Number: 10/H1208/37
Protocol number: PAKA/PROTOCOL/001 30 July 2010
Study design
Pilot single centre standard of care controlled trial double blinded pragmatic randomised trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Quality of life
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Muskuloskeletal, total knee arthroplasty, analgesia
Intervention
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
Intervention type
Drug
Phase
Not Applicable
Drug names
1. Levobupivicaine
2. Morphine
3. Ketorolac
Primary outcome measures
Visual Analogue Scale at 18 hours post operation
Secondary outcome measures
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
Overall trial start date
01/01/2010
Overall trial end date
31/12/2010
Reason abandoned
Eligibility
Participant inclusion criteria
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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
46
Participant exclusion criteria
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
Recruitment start date
01/01/2010
Recruitment end date
31/12/2010
Locations
Countries of recruitment
United Kingdom
Trial participating centre
University Hospitals Coventry & Warwickshire
Coventry
CV2 2DX
United Kingdom
Sponsor information
Organisation
University of Warwick (UK)
Sponsor details
c/o Peter Hedges
Research Support Services
University House
Coventry
CV4 8UW
United Kingdom
Sponsor type
University/education
Website
Funders
Funder type
Industry
Funder name
Astra Tech (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2012 results in: http://www.ncbi.nlm.nih.gov/pubmed/23188903
Publication citations
-
Results
Wallace DF, Emmett SR, Kang KK, Chahal GS, Hiskens R, Balasubramanian S, McGuinness K, Parsons H, Achten J, Costa ML, The safety of peri-articular local anaesthetic injection for patients undergoing total knee replacement with autologous blood transfusion: a randomised trial., J Bone Joint Surg Br, 2012, 94, 12, 1632-1636, doi: 10.1302/0301-620X.94B12.29357.