Study Evaluating the Efficacy of Loco-regional Anaesthesia PECS on the Rate of Chronic Pains 6 Month After a Mastectomy Associated or Not With Axillary Node Dissection and/or a Reconstruction Prosthesis.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 194
- 试验地点
- 1
- 主要终点
- Rate of chronic pain
研究概览
简要总结
A non-randomized, mono-centric, prospective interventional study that will assess the efficacy of the loco-regional anesthesia PECS on the rate of chronic pain, 6 month after a patient will have either received a mastectomy or a mastectomy associated with axillary nodes dissection, and/or a reconstruction by prosthesis.
详细描述
The aim of this study is to assess the care given to treat breast cancer while the patient receives a total mastectomy. It is done by evaluating the technique of anesthesia PECS used during this procedure so that the rate of chronic pain can be measured 6 month after the operation.
As well as total mastectomy, patients are also eligible for an axillary lymph node dissection (ALND) and a reconstruction of the breast by prosthesis as options.
Other objectives of the study include:
- Evaluating the effectiveness of the PECS anesthesia technique on the trajectory of acute post-operative pain and on chronic pain after 12 month of the surgery
- Evaluating the type and intensity of the pain
- Evaluating the quality of life
- Study the link between chronic pain and the trajectory of acute pain.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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 with unilateral breast cancer
- •Surgery must be a total mastectomy +/- axillary lymph node dissection and +/- reconstruction by prosthesis; unless first surgery was performed more than 5 years prior to total mastectomy without any residual pain
- •Age ≥ 18 ans
- •Non-opposition of patients
排除标准
- •Reconstruction by other than prosthesis
- •Previous breast surgery in the last year
- •Hypersensitivity or allergy of anaesthetics
- •Coagulopathy and local infections
- •Pregnant or breastfeeding
- •Patients under guardianship
研究组 & 干预措施
Loco-regional anaesthesia
Loco-regional anaesthesia Anesthesia technique used : loco-regional PECS for patients requiring Mastectomy; And/or Axillary node dissection ; And/or Reconstruction of breast by prosthesis
干预措施: Loco-regional anaesthesia (Procedure)
结局指标
主要结局
Rate of chronic pain
时间窗: 6 month after surgery
The rate of chronic pain will be assessed in percentage (%) based on the criteria of the International Association for the Study Pain (IASP) during an algology medical consultation.
次要结局
- Rate of chronic pain(12 month after the surgery)
- Side effects post-operative(During the 3 days following the surgery)
- predictive factors of survival(an average of 1 year)
- Quality of life of the patient assessed with the QLQ-BR23 questionnaire(an average of 1 year)
- Acute post-operative pain(During the 3 days following the surgery)
- Intensity of chronic pain(6 and 12 month after surgery)
- Depression assessed with the HADS questionnaire(an average of 1 year)
- Quality of life of the patient assessed with the QLQ-C30 questionnaire(an average of 1 year)
- Type of chronic pain(6 and 12 month after surgery)