Impact of Loco-regional Anesthesia Techniques on Chronic Post-surgery in Breast Oncological Surgery: a Prospective Multicenter Observational Study
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 1,500
- 试验地点
- 2
- 主要终点
- Incidence of chronic postoperative pain after major breast surgery
研究概览
简要总结
Approximately 55,000 cases of breast cancer are diagnosed in Italy every year and the first-line therapy for carcinoma in situ, stage I, II and IIIA is surgical removal of the tumour. The incidence of chronic pain after breast cancer surgery is confirmed around 30%. This study aims to evaluate the impact of loco-regional anesthesia techniques in the context of multimodal analgesia in the prevention of chronic pain post-oncological breast surgery
详细描述
Approximately 55,000 cases of breast cancer are diagnosed in Italy every year and the first-line therapy for carcinoma in situ, stage I, II and IIIA is surgical removal of the tumour. The incidence of chronic pain after breast cancer surgery is confirmed around 30%.Persistent postsurgical pain, defined in the ICD-11 as pain that develops or increases in intensity after a surgical procedure or tissue damage and persists beyond the healing process for at least 3 months after the initial event and is considered a complication of surgery.
Several pharmacological and non-pharmacological interventions have been proposed for the prevention of the development of this complication of surgical interventions, including the intraoperative use of local anesthesia techniques in the context of multimodal analgesia.
The purpose of this multicenter prospective observational study is to evaluate, through the propensity score methodology, how much the use of loco-regional anesthesia techniques can improve the outcome, in terms of the development of chronic post-surgical pain, of patients undergoing to oncological breast surgery
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
- •Oncological breast surgery:
- •simple mastectomy,
- •mastectomy + sentinel lymph node biopsy,
- •mastectomy + axillary hollowing,
- •mastectomy + reconstruction,
- •simple quadrantectomy,
- •quadrantectomy + sentinel lymph node biopsy,
- •quadrantectomy + axillary hollowing,
- •bilateral interventions will also be considered) Exclusion
- •Age < 18
排除标准
- 未提供
研究组 & 干预措施
Patients undergoing oncological breast surgery
- mastectomy + reconstruction
- simple quadrantectomy
- quadrantectomy + sentinel lymph node biopsy
- quadrantectomy + axillary hollowing
- bilateral interventions will also be considered
干预措施: Breast surgery (Procedure)
Patients undergoing oncological breast surgery
- mastectomy + reconstruction
- simple quadrantectomy
- quadrantectomy + sentinel lymph node biopsy
- quadrantectomy + axillary hollowing
- bilateral interventions will also be considered
干预措施: analgesia (Drug)
结局指标
主要结局
Incidence of chronic postoperative pain after major breast surgery
时间窗: 6 - 12 months
Incidence of chronic post-surgical pain after major breast surgery (definition: pain that persists at least 3 months after surgery; pain that was not present before surgery or that has different characteristics from pain before surgery or that has increased intensity than before the operation; the pain is localized in the area of the surgical site or in its radiation; other possible causes of pain are excluded)
次要结局
- Quality of life score(Quality of recovery score (QoR 15))
- Opioid(hour2, hour 6, hour 12 and hour 24 after surgery)
- Acute post-operative pain(2, 6, 12 and 24 hours)
- Chronic post-operative pain(3,6,9,12 months) at rest and on mobilization)
- Remifentanyl(Intraoperative)