Perioperative Analgesia for Knee Arthroplasty (PAKA) - a pilot randomised trial

ISRCTN ISRCTN29107680
DOI https://doi.org/10.1186/ISRCTN29107680
Secondary identifying numbers PAKA/PROTOCOL/V002
Submission date
18/01/2011
Registration date
01/06/2011
Last edited
16/05/2014
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Mr Matthew Costa
Scientific

University Hospitals Coventry & Warwickshire
Clinical Sciences Building 1st Floor
Clinical Sciences Reseach Institute
Clifford Bridge Road
Coventry
CV2 2DX
United Kingdom

Study information

Study designPilot single centre standard of care controlled trial double blinded pragmatic randomised trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeQuality of life
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific title
Study acronymPAKA
Study objectivesPeri-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(s)West Midlands Research Ethics Committee, REC Number: 10/H1208/37
Protocol number: PAKA/PROTOCOL/001 30 July 2010
Health condition(s) or problem(s) studiedMuskuloskeletal, total knee arthroplasty, analgesia
InterventionFemoral 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 typeDrug
Pharmaceutical study type(s)
PhaseNot Applicable
Drug / device / biological / vaccine name(s)1. Levobupivicaine 2. Morphine 3. Ketorolac
Primary outcome measureVisual Analogue Scale at 18 hours post operation
Secondary outcome measuresSerum 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 study start date01/01/2010
Completion date31/12/2010

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants46
Key inclusion criteriaAll 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
Key exclusion criteria1. 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
Date of first enrolment01/01/2010
Date of final enrolment31/12/2010

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

University Hospitals Coventry & Warwickshire
Coventry
CV2 2DX
United Kingdom

Sponsor information

University of Warwick (UK)
University/education

c/o Peter Hedges
Research Support Services
University House
Coventry
CV4 8UW
England
United Kingdom

Website http://www2.warwick.ac.uk/
ROR logo "ROR" https://ror.org/01a77tt86

Funders

Funder type

Industry

Astra Tech (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/12/2012 Yes No
HRA research summary 28/06/2023 No No