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

Results pending

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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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2015-06-30

Study Completion Date

2015-08-31

Brief Summary

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Assessing the association between patients' perceptions of success with post-operative pain management and overall experience with care.

Detailed Description

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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.

Conditions

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Postoperative Pain

Study Design

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Observational Model Type

COHORT

Study Time Perspective

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 must be 18 years of age or older
* 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 is having an operation other than the surgical procedures selected for inclusion (e.g., bilateral or partial hip replacement, or hip revision)
* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Medicines Company

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

Jupiter Medical Center

Jupiter, Florida, United States

Site Status

Phoenix Clinical Research LLC

Tamarac, Florida, United States

Site Status

Henry Ford Health System

Detroit, Michigan, United States

Site Status

Orthopaedic Associates of Michigan

Grand Rapids, Michigan, United States

Site Status

Drexel University

Philadelphia, Pennsylvania, United States

Site Status

Magee-Women's Hospital (UPMC)

Pittsburgh, Pennsylvania, United States

Site Status

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States

Site Status

Baylor Health Research Institute

Fort Worth, Texas, United States

Site Status

Countries

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United States

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.

Reference Type RESULT
PMID: 19565683 (View on PubMed)

Cohen, J. (1988). Statistical power analysis for the behavioral sciences (2nd ed.). Hillsdale, NJ: Lawrence Earlbaum Associates.

Reference Type RESULT

Other Identifiers

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MDCO-ERA-14-01

Identifier Type: -

Identifier Source: org_study_id

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