ISRCTN ISRCTN10868989
DOI https://doi.org/10.1186/ISRCTN10868989
Secondary identifying numbers 11157
Submission date
22/03/2012
Registration date
22/03/2012
Last edited
11/05/2018
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

Background and study aims
Total knee replacement (TKR) involves replacing a damaged, worn or diseased knee with an artificial joint. It's a routine operation for knee pain most commonly caused by arthritis. In 2007-8 the NHS undertook over 70,000 TKRs in England and Wales, and the number of TKRs is expected to rise as the population gets older. We know that patients experience significant pain after a TKR operation and this can increase the time taken to get back to walking and normal activities. Pain levels may be changed if the painkillers are taken by the patient when they want to take them (patient-directed self-management of pain) rather than when the nurse gives them as part of a drugs round in hospital (treatment as usual). This study will compare these two methods.

Who can participate?
Adult patients (aged over 18) undergoing a primary (first) TKR operation.

What does the study involve?
Participants will be randomly divided into the two groups: patient-directed self-management of pain or treatment as usual. This study will investigate whether patient-directed self-management of pain improves levels of pain at three days after the operation or at discharge (whichever is the sooner) compared to treatment as usual. It will also compare the two groups up to 6 weeks after the operation for satisfaction with control of pain, return to walking and normal activities, any problems, and costs. We will also interview 10 patients and 10 ward staff to explore their experiences of the two methods.

What are the possible benefits and risks of participating?
It is hoped that the results of this study will help the NHS to improve pain control for patients after TKR. Information from this study may well be relevant to pain control after operations in general.

Where is the study run from?
Norfolk and Norwich University Hospital NHS Trust (UK).

When is study starting and how long is it expected to run for?
June 2011 to June 2013.

Who is funding the study?
National Institute of Health Research (NIHR) (UK).

Who is the main contact?
Prof Simon Donell
simon.donell@nnuh.nhs.uk

Contact information

Prof Simon Donell
Scientific

Consultant Orthopaedic Surgeon & Honorary Professor
University of East Anglia
Norfolk and Norwich University Hospital NHS Trust
Colney Lane
Colney
Norwich
NR4 7UY
United Kingdom

Phone +44 (0)1603 287531
Email simon.donell@nnuh.nhs.uk

Study information

Study designOpen-label randomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleA randomised controlled trial of patient-directed self-management of pain (PaDSMaP) compared to treatment as usual following total knee replacement.
Study acronymPaDSMaP
Study objectivesTo investigate if PaDSMaP reduces pain at 3 days post-operatively or discharge (whichever is sooner) after primary total knee replacement compared to treatment as usual
Ethics approval(s)Cambridgeshire 1 Research Ethics Committee, 30/12/2010, ref: 10/H0304/52
Health condition(s) or problem(s) studiedMusculoskeletal disease: Total knee replacement
InterventionPatients self-medicate their oral analgesics post total knee replacement when sufficently recovered from the anaesthetic. Treatment as usual comparator cohort have analgesics dispensed as per usual by nurses on drug rounds

Follow up length: Six weeks; Study entry: Single randomisation only
Intervention typeProcedure/Surgery
Primary outcome measurePain levels for patients at three days post-operatively or at discharge (whichever is the sooner) as measure on a non-graded 10cm visual analogue scale (VAS)
Secondary outcome measures1. Pain during inpatient stay and after six weeks post-operatively (non graded 10cm VAS)
2. Satisfaction with pain levels patient questionnaire
3. Satisfaction with Information About Medicines Scale (SIMS)
4. EuroQOL EQ-5D questionnaire (EQ-5D)
5. Oxford Knee Score (OKS)
6. Time to mobilisation after operation (e.g. day on which patient was able to stand up and transfer from bed to chair)
7. Medication usage (Inpatient Prescription Chart and CRF)
8. Adverse events (CRF)
9. A health resources questionnaire
10. Qualitative evaluation of patient's and health professionals' experiences
Overall study start date30/06/2011
Completion date30/06/2013

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participantsPlanned Sample Size: 144; UK Sample Size: 144
Key inclusion criteria1. All adult patients (e.g. aged over 18) undergoing a primary total knee replacement operation
2. Must meet the Norfolk and Norwich University Hospital NHS Foundation Trust self-management of pain criteria
3. Are expected to require standard step 1-3 oral analgesics post-operatively (WHO 2009)
4. Post-operatively, patients must be awake and breathing independently, able to answer questions and follow commands to continue in the protocol
5. Are English speaking and literate (we expect patient participants to be able to read the information sheet and fill in a number of self-assessments)
6. Patients may have received regional blocks or epidural analgesia, and will start PaDSMaP or TAU as soon as they begin oral analgesia
Key exclusion criteria1. Expected to require intensive care
2. Known or suspected to be opioid tolerant or dependent
3. Regular users of any modified release opiate preparation for > two weeks prior to total knee replacement
4. Recent history of drug or alcohol abuse
5. Patients who lack competence to consent by reason or dementia or any other reason
6. Any patient who does not self-administer at home
Date of first enrolment30/06/2011
Date of final enrolment30/06/2013

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Norfolk and Norwich University Hospital NHS Trust
Norwich
NR4 7UY
United Kingdom

Sponsor information

Norfolk and Norwich University Hospital NHS Trust (UK)
Hospital/treatment centre

c/o Ms Kathryn Andrews
Colney Lane
Colney
Norwich
NR4 7UY
England
United Kingdom

Phone +44 (0)1603 286286
Email kathryn.andrews@nnuh.nhs.uk
Website http://www.nnuh.nhs.uk/
ROR logo "ROR" https://ror.org/01wspv808

Funders

Funder type

Government

National Institute of Health Research (NIHR) Research for Patient Benefit (RfPB) (UK) ref: PB-PG-1208-18121

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?
Protocol article protocol 05/11/2012 Yes No
Results article results 10/05/2018 Yes No

Editorial Notes

11/05/2018: Publication reference added.