urse vs patient management of postop pai

Completed

• Conditions: Musculoskeletal disease: Total knee replacement; Musculoskeletal Diseases

• Registration Number: ISRCTN10868989
• Lead Sponsor: orfolk and Norwich University Hospital NHS Trust (UK)

Brief Summary

2012 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/23126312 2018 results in: http://www.ncbi.nlm.nih.gov/pubmed/29743064

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-03-22
• Study Completion: 2013-06-30
• Last Update Posted: 11 June 2018

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 144

Inclusion Criteria

1. 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

Exclusion Criteria

1. 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pain 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 Measures

Name	Time	Method
1. Pain during inpatient stay and after six weeks post-operatively (non graded 10cm VAS)<br>2. Satisfaction with pain levels patient questionnaire<br>3. Satisfaction with Information About Medicines Scale (SIMS)<br>4. EuroQOL EQ-5D questionnaire (EQ-5D)<br>5. Oxford Knee Score (OKS)<br>6. Time to mobilisation after operation (e.g. day on which patient was able to stand up and transfer from bed to chair)<br>7. Medication usage (Inpatient Prescription Chart and CRF)<br>8. Adverse events (CRF)<br>9. A health resources questionnaire<br>10. Qualitative evaluation of patient's and health professionals' experiences