Intra-operative pain relief for patients following a total knee replacement.

Phase 1

Conditions: Osteoarthritis of the knee is a common problem
it causes inability to walk without pain and a reduction in activity levels. Total knee replacements are performed for relief of this disabilitating condition and are the most common form of joint replacement in the NHS.
MedDRA version: 17.0Level: LLTClassification code 10023476Term: Knee osteoarthritisSystem Organ Class: 100000004859
Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Registration Number: EUCTR2013-002439-10-GB

Lead Sponsor: niversity of Warwick

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 264

Inclusion Criteria

All patients undergoing an elective primary unilateral total knee arthroplasty under the care of an orthopaedic consultant at University Hospitals Coventry and Warwickshire NHS trust.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 150
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 100

Exclusion Criteria

A concomitant medical or psychiatric problem which, in the opinion of hte Investigator, would prevent completion of treatment or follow-up; patients with a pre-operative history neurological abnormality in the ipsilateral leg; patients with specific contraindication to the analgesia agents use; participation in a clinical trial of an investigational medicinal product in the last 90 days; previous entry in the present trial.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The aim of this study is to determine if there a difference in patient reported pain prior to physiotherapy on the first post operative day between patients managed with local knee injections (peri-articular),compared to the standard treatment (femoral nerve block),following a total knee replacement.<br><br>;Secondary Objective: The secondary aim is to assess the function and health outcome of the intervention group at 6 weeks post operation. ;Primary end point(s): The primary outcome measure for this study is pain on day one post-operatively, assessed using a 100mm visual analgue scale (VAS). VAS provides an accurate objective value for pain perceived by the patient, this scale is of most value when looking at change within individuals. ;Timepoint(s) of evaluation of this end point: The VAS taken on day one post operatively is the primary outcome measure. It will also be taken day two post operatively<br>

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): A functional patient reported knee score - the oxford knee score.<br>A general patient reported quality of life score - the EQ-5D<br>A battery of standard physiotherapy assessment.;Timepoint(s) of evaluation of this end point: the physio assessment will take place on day 1 and 2 post operatively.<br>The Oxford knee score and EQ-5D will be taken at baseline and 6 weeks post-operatively.