Association Between Patients' Perceptions of Success in Post-op Pain Management and Overall Experience With Care
NCT ID: NCT02389907
Last Updated: 2018-04-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
OBSERVATIONAL
2015-06-30
2015-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Total Hip Replacement Group
Adults who have undergone a total hip replacement
No interventions assigned to this group
Hysterectomy Group
Adults who have undergone a hysterectomy
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Subject (or their legally acceptable representative) must have signed an informed consent form (ICF) indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study
* Subject is receiving a unilateral total hip replacement or a hysterectomy (total abdominal hysterectomy, total abdominal hysterectomy/bilateral salpingo-oophorectomy, total vaginal hysterectomy, or total vaginal hysterectomy/salpingo-oophorectomy)
* Subject is expected to remain hospitalized for at least 24 hours post-operatively
* Subject is expected to experience pain requiring IV PCA or non-PCA (non-patient controlled opioids via IV, IM, SC, or PO routes of administration) opioids for at least 24 hours after surgery
* Subject is classified as American Society of Anesthesiology (ASA) category I, II, or III
* Subject is willing to complete the required post-operative survey measures to be completed in the hospital
* Subject is willing to complete a post-discharge survey (including HCAHPS survey instrument) via telephone approximately two-weeks (14 days) post-discharge
Exclusion Criteria
* Subject cannot read, write, and communicate in English
* Subject has a history of tolerance to opioids including those prescribed opioids in the 3 month period leading up to the perioperative period (i.e., a subject is considered to have a potential tolerance to opioids if for 4 consecutive days prior to surgery they have been taking a short acting/short acting combination opioid analgesic greater than 120 mg codein daily, 40 mg hydrocodone daily, 200 mg tramadol daily, or 40 mg oxycodone daily or if they were on any dose of strong opioid analgesic such as morphine, hydromorphone, or fentanyl)
* Subject has a history of allergy to opioids reported pre-operatively or documented in medical history
* Subject is scheduled to receive additional surgical procedures beyond those listed within 72 hours of the initial surgery
18 Years
ALL
No
Sponsors
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The Medicines Company
INDUSTRY
Responsible Party
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Principal Investigators
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Jeffrey Abraham, MSPT, MBA
Role: STUDY_DIRECTOR
The Medicines Company
Locations
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Bridgeport Hospital
Bridgeport, Connecticut, United States
Jupiter Medical Center
Jupiter, Florida, United States
Phoenix Clinical Research LLC
Tamarac, Florida, United States
Henry Ford Health System
Detroit, Michigan, United States
Orthopaedic Associates of Michigan
Grand Rapids, Michigan, United States
Drexel University
Philadelphia, Pennsylvania, United States
Magee-Women's Hospital (UPMC)
Pittsburgh, Pennsylvania, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
Baylor Health Research Institute
Fort Worth, Texas, United States
Countries
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References
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Cohen J. A power primer. Psychol Bull. 1992 Jul;112(1):155-9. doi: 10.1037//0033-2909.112.1.155.
Cohen, J. (1988). Statistical power analysis for the behavioral sciences (2nd ed.). Hillsdale, NJ: Lawrence Earlbaum Associates.
Other Identifiers
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MDCO-ERA-14-01
Identifier Type: -
Identifier Source: org_study_id
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