Perioperative Analgesia for Knee Arthroplasty
| ISRCTN | ISRCTN60611146 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN60611146 |
| EudraCT/CTIS number | 2013-002439-10 |
| ClinicalTrials.gov number | NCT01560767 |
| Secondary identifying numbers | 15232 |
- Submission date
- 08/11/2013
- Registration date
- 08/11/2013
- Last edited
- 13/08/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Plain English summary of protocol
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
Contact information
Scientific
Warwick Clinical Trials Unit
Clinical Sciences Research Laboratories
University Hospital Coventry and Warwickshire
Coventry
CV2 2DX
United Kingdom
 ORCID ID |
0000-0003-3149-3373 |
|---|---|
| P.D.H.Wall@warwick.ac.uk |
Study information
| Study design | Randomised; Interventional; Design type: Not specified, Treatment |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details of C.A.Lawrence below to request a patient information sheet |
| Scientific title | Perioperative Analgesia for Knee Arthroplasty: a prospective randomised controlled trial |
| Study acronym | PAKA |
| Study objectives | 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(s) | 13/WM/0316; First MREC approval date 23/09/2013 |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 30/09/2013 |
| Completion date | 31/10/2015 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 264; UK Sample Size: 264 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/12/2013 |
| Date of final enrolment | 31/10/2015 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
CV2 2DX
United Kingdom
Sponsor information
Hospital/treatment centre
Clinical Sciences Research Unit
Clinical Sciences Building
Clifford Bridge Road
Coventry
CV2 2DX
England
United Kingdom
"ROR" |
https://ror.org/025n38288 |
|---|
Funders
Funder type
Government
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan | The data sharing plans for the current study are unknown and will be made available at a later date |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 21/12/2015 | Yes | No | |
| Results article | results | 01/07/2017 | Yes | No | |
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
13/08/2019: ClinicalTrials.gov number added.
18/12/2018: The following changes were made to the trial record:
1. Publication reference added.
2. IPD sharing statement added.
3. Contact details updated.
22/12/2015: Publication reference added.
