Longitudinal Assessment of Pain-related Patient-reported Outcomes in the Sub-acute Phase After Surgery: a Registry Study From PAIN OUT
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 1,000
- 试验地点
- 16
- 主要终点
- The difference in pain interference scores between postoperative day 7 (POD7) and 1 month after surgery (POM1).
研究概览
简要总结
Little is known about pain-related outcomes experienced by patients in the first few weeks after surgery, once they are discharged from hospital.
This study aims to characterize pain, pain-related interference, and early neuropathic pain in the sub-acute phase after surgery.
详细描述
A high proportion of patients experience moderate to severe pain after surgery. However, most of the knowledge about this comes from studies where patients are evaluated in the hours and up until the first postoperative day. Alternatively, patients are assessed several months (eg 3 or later) after surgery, to evaluate the development of chronic pain related to surgery (CPSP) and most patients do not develop CPSP.
This study aims to learn how patients recover concerning pain and function once they return home after surgery. How long is it before they can resume their daily activities and to do so in comfort? Do they take treatment for pain? Do they have pain restricted to the surgical incision or it is more widespread? There is little knowledge as to whether there are signs of nerve injury in the days close to surgery. This type of pain might lead to chronic pain in later stages.
Patients will be assessed at three time points: the first day after surgery, the 7th day after surgery, and 1 month.
The information we obtain will offer healthcare providers, from multiple hospitals, information about the care they provide to their patients for pain while patients are still in hospital and insights as to how the care might be improved, once they are discharged.
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
- •On the first post-operative day and back on the ward for at least 6 hours
- •Gives consent for assessment at 3-time points
排除标准
- •The patient is unable to communicate
- •The patient is cognitively impaired
- •The patient is asleep
- •The patient is too ill or in too much pain and does not wish to be interviewed
- •The patient does not wish to fill in the outcomes questionnaire
结局指标
主要结局
The difference in pain interference scores between postoperative day 7 (POD7) and 1 month after surgery (POM1).
时间窗: 7th day after surgery (POD7) and 1 Month (M1) after surgery
We will assess whether pain-related functional impairment on postoperative day 7 is associated with functional pain-related impairment 1 month after surgery. Functional pain impairment will be assessed using the BPI short-form questionnaire and calculated as a Pain Interference Total Score (PITS) from the 7 interference questions in the BPI. Patients will be allocated to groups of no (PITS=0)/mild-(PITS=1-2)/ moderate /(PITS=2-5) and severe interference (PITS\>5). Mean scores of the 2 domains within the functional items, physical interference (general activity, walking ability, and work) and effective interference (mood, enjoyment of life, and relations with other persons) will also be calculated. Sleep will addressed separately as it does not improve psychometric properties of the BPI interference scale. This methodology has been used in another PAIN OUT study, evaluating function at 6 months after surgery (Stamer et al, Pain. 2019 Aug;160(8):1856-1865).
The number of patients with high pain interference on the 7th day after surgery (POD7).
时间窗: Day 7 after surgery
Number of patients with high pain interference at postoperative day 7 (POD7, BPI-PITS \>5).
次要结局
- The differences in pain interference (BPI-PITS) between surgical disciplines at month 1 after surgery.(1 Month after surgery)
- Differences in pain severity (BPI-PSVS, pain severity scale) between postoperative day 7 and 1 month after surgery (POM1).(Day 7 after surgery and Month 1 after surgery)
- Differences in pain severity between patients with vs without signs of neuropathy at POM1(1 Month after surgery)
- Assess the difference in the number of patients taking analgesics o POD7 vs POD1.(Day 7 after surgery and 1 Month after surgery)
- The differences in pain interference (BPI-PITS) between surgical disciplines on postoperative day 7.(Day 7 after surgery)
- The difference in the number of patients with signs of neuropathy on postoperative day 7 between the surgical disciplines.(Day 7 after surgery)
- The difference in the number of patients with signs of neuropathy at 1 month after surgery (POM1) between the surgical disciplines.(1 Month after surgery)
- Differences in pain interference scores between patients with vs without signs of neuropathy on postoperative day 7(Day 7 after surgery)
- Differences in pain interference (BPI-PITS) between patients with vs. without signs of neuropathy (DN2 score ≥ 3/7) at POM1.(1 Month after surgery)
研究者
Ruth Zaslansky
PAIN OUT - scientific director
Jena University Hospital