Condition category
Musculoskeletal Diseases
Date applied
18/01/2011
Date assigned
01/06/2011
Last edited
16/05/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mr Matthew Costa

ORCID ID

Contact details

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

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

http://www2.warwick.ac.uk/

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

  1. 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.

Additional files

Editorial Notes