Characterization of Post-operative Pain Trajectories Over Seven Days and Their Potential Links With Chronicity After 3 Months: a Single-center, Prospective, Pilot Cohort Study at the Nîmes University Hospital
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 392
- 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 main objective of this study is to establish the postoperative "pain pathways" observed from D1 to D7 in the context of the current management after orthopedic, digestive, obstetrics and gynecology, urology, neurosurgery, vascular and thoracicn surgeries.
详细描述
The secondary objectives of this study are:
A. To assess the incidence of Post-Surgical Chronic Pain (PSCP) Chronic 3 months post intervention.
B. To asses the incidence of neuropathic type pain (DN4 Questionnaire) at 3 months post intervention.
C. To study the potential links between pain trajectories and the presence or absence of PSCP.
D. To study the potential links between the presence or absence of PSCP and known risk factors for PSCP (patient-related data, data on the surgery, anesthesia data).
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 (HADS, PCS, EN, DN4)
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 post-surgery
The pain trajectory is the vector of 7 verbal numerical pain estimates (from 0 to 10) taken over 7 days (days 1 (or -1), 2, 3, 4, 5, 6 \& 7). Day 0 is the day of surgery.
次要结局
- The DN4 questionnaire(month 3)
- Since the surgery, do you have persistent pain? yes/no(month 3)
- Have you had complications from your surgery? yes/no(month 3)
- Hospital Anxiety and Depression Scale (HADS)(day -1 or day +1)
- Pain Catastrophizing Scale (PCS)(day -1 or day +1)
- Cumulative consumption of antalgic drugs(day 7)
- Is it the same pain before the surgery? yes/no(month 3)
- Verbal numberical scale for pain (ranging from 0 to 10)(month 3)