Assessing the Association Between Patients' Perceptions of Success With Post-Operative Pain Management and Overall Experience With Care
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 9
- 主要终点
- Patient Global Assessment (PGA) and Hospital Consumer Assessment of Healthcare providers and Systems (HCAHPS)
研究概览
简要总结
Assessing the association between patients' perceptions of success with post-operative pain management and overall experience with care.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Patient Global Assessment (PGA) and Hospital Consumer Assessment of Healthcare providers and Systems (HCAHPS)
时间窗: 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
次要结局
- Post-Operative Pain Management Modality(14 days post discharge)