Characterization of Bio-psychosocial Pain Profiles in the Perioperative Period
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 471
- 试验地点
- 1
- 主要终点
- Pain phenotypes
研究概览
简要总结
This is a prospective descriptive correlational design looking to characterize postoperative pain variables across various procedures that historically have significant levels of persistent post-surgical pain
详细描述
This is a two institution (Naval Medical Center San Diego and Walter Reed National Military Medical Center) prospective descriptive correlational design looking to characterize postoperative pain variables across various procedures that historically have significant levels of persistent post-surgical pain.
A total goal of 1500 subjects (750 subjects at Walter Reed National Military Medical Center and 750 subjects at Naval Medical Center San Diego) will be queried regarding their postoperative pain experience following mastectomy, thoracic surgery, total knee arthroplasty, total hip arthroplasty, spinal fusion, and major abdominal surgery. Descriptive multidimensional tools (the Defense and Veterans Pain Rating Scale (DVPRS) and the electronic Pain Assessment Screening Tool and Outcomes Registry (PASTOR) will be used preoperatively, as an inpatient, and up to 6 months postoperatively.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Be between the ages of 18 and 80 and having any of the following surgical procedures: mastectomy, thoracic surgery, total knee arthroplasty, total hip arthroplasty, spinal fusion, and major abdominal surgery.
- •DEERS eligible
排除标准
- •Total Hip/Total Knee arthroplasty revision Younger than 18 years old Refuse participation Cannot understand English Has cognitive deficiencies (subject unable to provide consent for the study, subject unable to complete initial post consent measures)
结局指标
主要结局
Pain phenotypes
时间窗: perioperatively to 6 months
To describe various pain phenotypes via multidimensional pain measures throughout the subacute (7 days to 6 months) perioperative period. This description will focus on certain time points but also how such measures change over time (ie pain trajectories)
DVPRS
时间窗: perioperatively to 6 months
To determine how predictive PASTOR/PROMIS measures are for moderate to severe acute postoperative pain as measured by the DVPRS within the first 48 hours postoperatively for all surgical groups and between surgical groups.
PASTOR/PROMIS
时间窗: perioperatively to 6 months
To assess any predictive/correlative capability of early postoperative PASTOR/PROMIS measures (7 days,14 days, and 1 month postoperatively) in the prediction of persistent pain at 3 and 6 months for all surgical groups and between surgical groups
次要结局
未报告次要终点