Evaluation of Pain Trajectories After Surgery and Their Potential Relationship With Chronicity at 3 Months: a Single-center Prospective Cohort Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 5,000
- 试验地点
- 1
- 主要终点
- The pain trajectory for the first 7 post-operative days.
研究概览
简要总结
The effective management of acute postoperative pain remains a daily challenge despite the organizational efforts made and the techniques put in place.
Thirty percent of patients who undergo surgery suffer from chronic post-surgical pain, of which 5 to 10% are of severe intensity. Many preoperative, intraoperative, and postoperative factors, related to the patient, the surgical procedure, or the anesthetic technique, have been incriminated as risk factors for chronic post-surgical pain. The severity of acute postoperative pain is recognized as one of the risk factors for the occurrence of chronic post-surgical pain on which we can hope to interact during the peri-operative period.
In this cohort study, we wish to define the typologies of postoperative pain trajectories observed from Day 0 to Day 7 and to estimate the proportion of patients with an abnormal resolution of pain in a model of organization such as that of our institution, in classic hospitalization and in ambulatory care.
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
- •The patient must be insured or beneficiary of a health insurance plan
- •The patient is available for 3 months of follow-up
- •The patient has undergone a planned surgical procedure in one of the participating departments
- •The patient is willing and able to respond to the study questionnaires
排除标准
- •The patient is participating in another study
- •The patient is in an exclusion period determined by a previous study
- •The patient is under judicial protection, under tutorship or curatorship
- •It is impossible to correctly inform the patient
- •Patient admitted to the ICU and still intubated at day 1
结局指标
主要结局
The pain trajectory for the first 7 post-operative days.
时间窗: Day 7
The pain trajectory is the change in pain level evaluated by verbal numerical pain (from 0 to 10) from day 0 (surgery) to day 7.
次要结局
- The EuroQuol EQ5D5L questionnaire(month 3)
- Have you had complications from your surgery? yes/no(month 3)
- Cumulative consumption of antalgic drugs(day 7)
- The DN4 questionnaire(month 3)
- Pain Catastrophizing Scale (PCS)(day -1 or day +1)
- Since the surgery, do you have persistent pain? yes/no(month 3)
- Verbal numerical scale for pain (ranging from 0 to 10)(month 3)