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The study was not developed due to the cessation of IONSYS marketing
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Assessing the association between patients' perceptions of success with post-operative pain management and overall experience with care.
A study to assess the association between patients' perceptions of success with post-operative pain management following total hip replacement or hysterectomy surgery and their later perception of pain management while in the hospital and the hospital overall.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Total Hip Replacement Group | Adults who have undergone a total hip replacement | ||
| Hysterectomy Group | Adults who have undergone a hysterectomy |
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| Measure | Description | Time Frame |
|---|---|---|
| Patient Global Assessment (PGA) and Hospital Consumer Assessment of Healthcare providers and Systems (HCAHPS) | Assess the association between patients' perceptions of success with opioid post-operative pain management following total hip replacement or hysterectomy surgery as measured by a patient global assessment (PGA) at 24 hours post-op and at 48 hours post-op, and their perception of pain management while in the hospital and the hospital overall, as measured by the Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) instrument two-weeks (14 days) post-discharge | 24 hours - 14 days post discharge |
| Measure | Description | Time Frame |
|---|---|---|
| Post-Operative Pain Management Modality | Determine whether there are differences in patients' perception of pain management while in the hospital and the hospital overall with respect to post-operative pain management modality | 14 days post discharge |
| Measure | Description | Time Frame |
|---|---|---|
| Composite outcome measures consisting of multiple measures | Depending on available statistical power, other relevant constructs, including pain severity and mobility, as measured by BPI, a one-item Pain Numerical Rating Scale (NRS), and mobility items from the Ease of Care (EOC) Questionnaire, as well as patient demographic characteristics and medical/medication history will be taken into account when assessing the primary and secondary objectives. |
Inclusion Criteria:
Exclusion Criteria:
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Study population will include adults 18 years of age or older who have undergone either a total hip replacement or hysterectomy.
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| Name | Affiliation | Role |
|---|---|---|
| Jeffrey Abraham, MSPT, MBA | The Medicines Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bridgeport Hospital | Bridgeport | Connecticut | 06610 | United States | ||
| Jupiter Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19565683 | Result | Cohen J. A power primer. Psychol Bull. 1992 Jul;112(1):155-9. doi: 10.1037//0033-2909.112.1.155. | |
| Result | Cohen, J. (1988). Statistical power analysis for the behavioral sciences (2nd ed.). Hillsdale, NJ: Lawrence Earlbaum Associates. |
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| 48 Hours Post Op |
| Jupiter |
| Florida |
| 33458 |
| United States |
| Phoenix Clinical Research LLC | Tamarac | Florida | 33321 | United States |
| Henry Ford Health System | Detroit | Michigan | 48202 | United States |
| Orthopaedic Associates of Michigan | Grand Rapids | Michigan | 49525 | United States |
| Drexel University | Philadelphia | Pennsylvania | 19104 | United States |
| Magee-Women's Hospital (UPMC) | Pittsburgh | Pennsylvania | 15213 | United States |
| University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | 15232 | United States |
| Baylor Health Research Institute | Fort Worth | Texas | 76104 | United States |
| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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