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Clinical Trials/ISRCTN12559751
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

Registry
who.int
Start Date
May 23, 2017
End Date
November 23, 2017
Last Updated
8 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
ISAL Foundation

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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