Plain English Summary
Background and study aims
The aim of this study is to find out if there is a difference in pain prior to physiotherapy on the first day after the operation between patients who are given local knee injections following a total knee replacement, compared to the standard treatment (femoral nerve block). Another aim of this study is to assess the function and health outcome of the study group at 6 weeks after the operation.
Who can participate?
All patients undergoing a total knee replacement surgery under the care of an orthopaedic consultant at the University Hospitals Coventry and Warwickshire NHS Trust, UK.
What does the study involve?
Patients will be randomly allocated to receive either local knee injections or standard treatment. On the first and second day after the operation, participants will be asked to rate their pain in and around their knee before and after physiotherapy. In addition, patients will be followed up at 6-8 weeks after the operation.
What are the possible benefits and risks of participating?
There are no specific advantages to you taking part in the study. However, the information we get from this study may help up to choose the best type of pain relief for patients having the same sort of surgery as you in the future.
Where is the study run from?
Warwick Orthopaedics, University of Warwick, UK.
When is the study starting and how long is it expected to run for?
The study will begin recruiting in December 2013 for 24 months.
Who is funding the study?
The study is being funded by the National Institute for Health Research (NIHR) (UK).
Who is the main contact?
Mr Peter Wall
P.D.H.Wall@warwick.ac.uk
Trial website
Contact information
Type
Scientific
Primary contact
Mr Peter Wall
ORCID ID
http://orcid.org/0000-0003-3149-3373
Contact details
Warwick Clinical Trials Unit
Clinical Sciences Research Laboratories
University Hospital Coventry and Warwickshire
Coventry
CV2 2DX
United Kingdom
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P.D.H.Wall@warwick.ac.uk
Additional identifiers
EudraCT number
2013-002439-10
ClinicalTrials.gov number
Protocol/serial number
15232
Study information
Scientific title
Perioperative Analgesia for Knee Arthroplasty: a prospective randomised controlled trial
Acronym
PAKA
Study hypothesis
Arthritis 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 debilitating pain and are the most common form of joint replacement performed within the NHS. Increased demand for total knee replacement, together with an ageing population, has led to an annual increase in frequency of this form of replacement. The operation involves removing worn-out surfaces and replacing them with implants.
Knee replacement generates substantial amounts of postoperative pain, which affects range of movement and ability to mobilise. It is important that good pain relief is administered post-operatively to enhance patient rehabilitation. Current pain relief targets large groups of nerves, paralysing areas of the body of limb. Recently, the use of injections around the knee has gained in popularity. These injections have the advantage of delivering drugs directly to the sources of pain, thereby avoiding side effects in the rest of the body. They contain different analgesics, such as local anaesthetics, opiates and non-steriodal anti-inflammatory drugs. Some of the theorectical advantages include reduced requirements for painkillers after the operation, and earlier mobilisation, discharge and better overall outcome following knee surgery.
We propose to perform a single-centre patient-based randomised controlled trial of local knee injections (peri-articular infiltration) versus standard treatment (femoral nerve block) with pain as the primary outcome measure. In preparation for this study we have performed a pilot study recruiting 46 patients which has supplied us with the data required to plan this full trial.
Ethics approval
13/WM/0316; First MREC approval date 23/09/2013
Study design
Randomised; Interventional; Design type: Not specified, Treatment
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details of C.A.Lawrence below to request a patient information sheet
Condition
Topic: Musculoskeletal; Subtopic: Musculoskeletal (all Subtopics); Disease: Musculoskeletal
Intervention
Femoral Nerve Block, Standard femoral nerve block; Periarticular infiltration, A multi-modal peri-articular knee infiltration; Follow Up Length: 2 month(s); Study Entry: Single Randomisation only
Randomisation will be stratified between general anaesthetic and spinal block.
Data will be collected at the follow time points: baseline, day 1 and day 2 post-operation, 6 weeks post operation
Intervention type
Procedure/Surgery
Phase
Drug names
Primary outcome measure
Visual Analogue Scale; Timepoint(s): Pre-physiotherapy on the first post-operative day
Secondary outcome measures
1. As required analgesia; timepoint(s): the total use of as required analgesia in the first 48 hours after the operation
2. Bed transfers; timepoint(s): day 1 and 2 postoperatively
3. Distance mobilised; timepoint(s): day 1 and 2 postoperatively
4. EQ-5D-5L; timepoint(s): baseline and 6 weeks postoperatively
5. Knee range of movement; timepoint(s): day 1 and 2 postoperatively
6. Ordinal Pain Score; timepoint(s): routinely collected by nursing staff every 6 hours for the first 48 hours following surgery
7. Oxford Knee Score; timepoint(s): baseline and 6 weeks postoperatively
8. Routine physio assessments
9. Bed transfers and distance mobilised
9. Straight leg raise; timepoint(s): day 1 and 2 postoperatively
10. Timed up and go; timepoint(s): day 1 and 2 postoperatively
Overall trial start date
30/09/2013
Overall trial end date
31/10/2015
Reason abandoned (if study stopped)
Eligibility
Participant 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.
Target Gender: Male & Female ; Lower Age Limit 18 years
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Planned Sample Size: 264; UK Sample Size: 264
Participant exclusion criteria
1. A concomitant medical or psychiatric problem which, in the opinion of the Investigator, would prevent completion of treatment or follow-up
2. Patients with a preoperative history of neurological abnormality in the ipsilateral leg
3. Patients with specific contraindication to the analgesic agents used
4. Participation in a clinical trial of an investigational medicinal product in the last 90 days
5. Previous entry in the present trial
Recruitment start date
01/12/2013
Recruitment end date
31/10/2015
Locations
Countries of recruitment
United Kingdom
Trial participating centre
University Hospitals Coventry & Warwickshire NHS Trust
Coventry
CV2 2DX
United Kingdom
Funders
Funder type
Government
Funder name
National Institute for Health Research Central Commissioning Facility; Grant Codes: PB-PG-0212-27098
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
IPD sharing statement
The data sharing plans for the current study are unknown and will be made available at a later date
Intention to publish date
Participant level data
To be made available at a later date
Basic results (scientific)
Publication list
2015 protocol in: https://www.ncbi.nlm.nih.gov/pubmed/26692559
2017 results in: https://www.ncbi.nlm.nih.gov/pubmed/28663395