POPARTS Study- Post-Operative Pain After Recovery in Thoracic Surgery: Evaluation of the Persistence of Painful Symptoms and the Incidence of Neuropathic Pain After Resective Lung Surgery
试验速览
- 阶段
- 不适用
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- Incidence of persistent post-operative pain after thoracic surgery
研究概览
简要总结
Persistent pain after surgery has significant physical and mental consequences for the patient, as well as a significant economic impact on health systems. Neuropathic pain is caused by direct or indirect damage to the somatosensitive system. In thoracic surgery, chronic neuropathic pain is represented by Post-Thoracotomic Pain Syndrome (PTPS), defined as recurrent or persistent pain in the thoracotomy scar site that persists for more than 3-6 months. Currently, in literature, the prevalence of PTPS is extremely variable. This prospective observational study aims to assess the incidence of pain in the weeks and months following surgery and to assess whether and how the presence of painful symptoms changes the patient's quality of life.
详细描述
For each patient enrolled in the study, in the pre-operative phase, comorbidities, any chronic analgesic therapy and quality of life (through a dedicated questionnaire - Euro QoL 5D5L1) will be recorded. Surgical data (type of procedure, lobe affected by resection, type of approach and surgical time) and anesthesiological data (intravenous opioid, locoregional technique (s), non-opioid analgesics administered and other medications) will be collected in the perioperative phase. In the 48 hours following the surgery (in the Recovery Room, at 6h, 12h, 24h, 36h and 48h) the patient's pain data will be recorded (static, dynamic and cough-associated NRS) and those relating to any complications. The total amount of morphine administered to the patient in the first 48 hours will also be recorded. Each patient will be evaluated 7 days, 1, 3 and 6 months after the surgery by telephone interview. In this last phase, the possible presence of pain and its characteristics will be assessed, especially if these meet the criteria of neuropathic pain.
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
- •Age ≥ 18 years
- •Patient's consent to the trial
- •Candidate to resective lung surgery (lobectomy, segmentectomy, atypical resection) with minimally invasive approach (mini-thoracotomy with muscle sparing or video-assisted thoracic surgery, VATS)
排除标准
- •neurological and / or cognitive deficits
- •inability to obtain informed consent
- •surgeries that include wall resections (pleural, muscle, rib or nerve)
- •pneumonectomy
- •Previous thoracic surgery at the time of enrollment
结局指标
主要结局
Incidence of persistent post-operative pain after thoracic surgery
时间窗: the data needed to analyze the incidence and characteristics of pain will be collected at 1 month after surgery
The incidence of static, dynamic and cough-associated pain is assessed through the numerical rate scale (NRS), by a telephone interview one week and one month after surgery. A questionnaire is submitted to the patient to analyze the characteristics of the pain and its possible impact on the patient's quality of life.
Incidence of Chronic Pain after thoracic surgery
时间窗: The data needed to analyze the presence of chronic pain will be collected at 6 months after surgery
The possible presence and incidence of chronic pain is assessed through a telephone interview three and six months after surgery.
Presence of pain with typical features of neuropathic pain in the different phases of the postoperative course
时间窗: The data neede to analyze the presence of neuropathic pain will be collected at 6 months after the surgery
During each telephone interview the presence of neuropathic pain is assessed through a dedicated questionnaire (PainDetect Questionnaire) and the impact that this type of pain has on the patient's quality of life.
次要结局
- Assessment of the incidence of chronic pain based on the different surgical techniques in thoracic surgery(during the intraoperative phase, data relating to the surgical techniques performed are collected)
- Assessment of the post-operative quality of life based on the different surgical techniques in thoracic surgery(during the intraoperative phase, data relating to the surgical techniques performed are collected)
- Evaluation of postoperative pain control based on different anesthesiological techniques and its possible correlation with the development of chronic pain(data relating to this objective are collected in the intraoperative, 24 hours after surgery and subsequent telephone interviews at 1 week, 1, 3 and 6 months after thoracic surgery)
研究者
Marzia Umari
Principal Investigator
University of Trieste