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Clinical Trials/ISRCTN10868989
ISRCTN10868989
Completed
Not Applicable

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

orfolk and Norwich University Hospital NHS Trust (UK)0 sites144 target enrollmentMarch 22, 2012
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Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Not specified
Sponsor
orfolk and Norwich University Hospital NHS Trust (UK)
Enrollment
144
Status
Completed
Last Updated
7 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

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

Registry
who.int
Start Date
March 22, 2012
End Date
June 30, 2013
Last Updated
7 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
orfolk and Norwich University Hospital NHS Trust (UK)

Eligibility 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

  • •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

Outcomes

Primary Outcomes

Not specified

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