Enhanced vs. Standard Pain Management of Patients at Risk for Chronic Post-surgical Pain: a Randomized Controlled Pilot Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- recruitment rate
研究概览
简要总结
The goal of this pragmatic pilot clinical trial is to test the feasibility of the trial in terms of the number of patients recruited in a given period.
The main question it aims to answer is to assess the number of eligible patients and number of patients willing to participate per month.
Participants will be followed either by the team of "transitional pain service" (intervention group) or by a surgeon or the general practitioner (standard care). Depending on individual risk factors, patients in the intervention group will be offered some targeted measures, for example:
- hypnosis,
- patient education,
- evaluation by psychiatrist,
- psychotherapy,
- locoregional anesthesia,
- anti-depressant treatment Participants (in both intervention and standard care groups) will be asked to answer some questions before surgery, during the first week following the surgery and six months after the surgery.
详细描述
Moderate to severe persistent post-surgery pain occurs in up to 12% of patients at 6 months post-surgery according to the large European study cohort. Our own data from a previous study at the University Hospitals of Geneva (HUG) (unpublished, alerte douleur-ALDO study) showed a prevalence of chronic post-surgical pain (CPSP) 6 months after selected types of surgery of 30.9%. Strategies to detect and prevent CPSP have not been applied systematically in clinical practice until now, despite routine surgical follow-up visits after surgery.
There are only few hospitals who have implemented a "transitional pain service (TPS)" to diminish the risk of the transition of acute to chronic pain after surgery, and the Anesthesia Department of the University Hospitals of Geneva is currently experimenting with such a team. A future study needs to validate the effectiveness of this approach.
The present study is planned as a pilot trial to test the feasibility, usability, acceptance, and to provide the parameters necessary to design this future study validating or refuting the utility of individually targeted combinations of preventive measures implemented by a "transitional pain service" in reducing the incidence of chronic pain 6 months after surgery.
The primary objective is to evaluate the feasibility of the trial in terms of the number of patients recruited in a given period.
Secondary objectives are:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
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
- •patients scheduled for spine surgery or total knee replacement surgery or thoracic surgery
- •patients of 18 years or more
- •ability to speak and read French
排除标准
- •inability to consent and to follow the procedures of the study
- •emergency surgery
研究组 & 干预措施
Individualised Pain Management
In the intervention group, patients will be followed by the team of the "transitional pain service" of the HUG, and depending on individual risk factors, contraindications and following discussion with the patient (shared decision-making) the bundle of individually targeted measures will be applied.
干预措施: Individualised pain management (Other)
Standard care
In the control group, no specific measures will be applied, and patients are followed by their surgeon and general practitioner. In addition, during the hospitalization the Acute Pain Team may be requested. In case of persistent pain, it may happen that the surgeon or the general practitioner refers a patient to a chronic pain specialist.
结局指标
主要结局
recruitment rate
时间窗: 6 months
number of patients included in the study per month
次要结局
- Data completeness rate(6 months)
- Retention rate(6 months)
- Number of measures accepted at 6 months(6 months)
- Number of measures completed at 6 months(6 months)
- Usefulness of a "transitional pain service" (TPS) from a patient perspective(6 months)
研究者
Paulina Sypniewska El Khoury, MD
Principal Investigator
University Hospital, Geneva