ISRCTN12559751
Completed
Phase 4
An interventional, double-blind randomized parallel-group, phase IV study for the assessment of a tailored Opioid therapy and osteoarthritic chronic pain bioMarkers, to improve Arthoprosthesis patients rehabilitation (OpMarkArt)
ISAL Foundation0 sites60 target enrollmentMay 23, 2017
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- ISAL Foundation
- Enrollment
- 60
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief Summary
2017 protocol in: https://www.ncbi.nlm.nih.gov/pubmed/29258584
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Patients who started opioid analgesics category and will undergo total hip arthroplasty for osteoarthritis or aseptic necrosis of the femoral head
- •2\. Patients who started NonSteroidal Anti\-Inflammatory Drugs (NSAIDs) and will undergo total hip arthroplasty (THA) for osteoarthritis or aseptic necrosis of the femoral head
- •3\. Males and female adults (from 18 years old)
Exclusion Criteria
- •1\. Unstable neurological pathologies
- •2\. Uncompensated diabetes
- •3\. Previous abdominal surgery with dynamic ileum risk
- •4\. Viral infective pathologies
- •5\. Patients unable to fill the informed consent form
- •6\. Patients needing post\-surgery mechanical ventilation
- •7\. Patients attending a secondary surgery
- •8\. Retreated patients
Outcomes
Primary Outcomes
Not specified
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