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Nurse vs patient management of postop pain

A randomised controlled trial of patient-directed self-management of pain (PaDSMaP) compared to treatment as usual following total knee replacement.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN10868989
Enrollment
144
Registered
2012-03-22
Start date
2011-06-30
Completion date
Unknown
Last updated
2018-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Musculoskeletal disease: Total knee replacement Musculoskeletal Diseases

Interventions

Patients 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

Sponsors

Norfolk and Norwich University Hospital NHS Trust (UK)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
1. 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

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 24, 2026