Association Between Patients' Perceptions of Success in Post-op Pain Management and Overall Experience With Care



Status:Withdrawn
Conditions:Post-Surgical Pain
Therapuetic Areas:Musculoskeletal
Healthy:No
Age Range:18 - Any
Updated:4/28/2018
Start Date:June 2015
End Date:August 2015

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Assessing the Association Between Patients' Perceptions of Success With Post-Operative Pain Management and Overall Experience With Care

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.

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
We found this trial at
9
sites
Fort Worth, Texas 76104
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Jupiter, Florida 33458
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Jupiter, FL
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Bridgeport, Connecticut 06610
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Bridgeport, CT
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Detroit, Michigan 48202
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Detroit, MI
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Grand Rapids, Michigan 49525
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Grand Rapids, MI
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3301 Lancaster Avenue
Philadelphia, Pennsylvania 19102
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Philadelphia, PA
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300 Halket St.
Pittsburgh, Pennsylvania 15213
1-866-MyMagee (696-2433)
Magee-Womens Hospital of UPMC Magee-Womens Hospital of UPMC is a world-class center for both women's...
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Pittsburgh, PA
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200 Lothrop St
Pittsburgh, Pennsylvania 15213
University of Pittsburgh Medical Center UPMC is one of the leading nonprofit health systems in...
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Pittsburgh, PA
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Tamarac, Florida 33321
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Tamarac, FL
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