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

Study Overview
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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.

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

Conditions
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Postoperative Pain

Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Total Hip Replacement Group<br>Adults who have undergone a total hip replacement | |
| Hysterectomy Group<br>Adults who have undergone a hysterectomy | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 |