Postoperative Pain
Conditions
Brief summary
Assessing the association between patients' perceptions of success with post-operative pain management and overall experience with care.
Detailed description
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.
Interventions
None listed
Sponsors
The Medicines Company
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient Global Assessment (PGA) and Hospital Consumer Assessment of Healthcare providers and Systems (HCAHPS) | 24 hours - 14 days post discharge | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Post-Operative Pain Management Modality | 14 days post discharge | 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Composite outcome measures consisting of multiple measures | 48 Hours Post Op | 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. |
Countries
United States
Outcome results
None listed