Contribution of Auriculotherapy in the Management of Mastectomy With Immediate Reconstruction by Latissimus Dorsi Flap (ATMAGD)
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Presence, or not, of Chronic Post-Surgical Pain (DCPC)
研究概览
简要总结
Over the past decade, more and more healthcare professionals are using auriculotherapy as a preventative and effective therapy for pain. This therapy is applied by odontologists, anesthetists, surgeons, etc., to alleviate chronic pain. The effects of auriculotherapy are known in particular in reducing preoperative anxiety, pain in cancer patients and postoperative pain.
The aim of this study is to assess the effectiveness of adding auriculotherapy to the standard global anesthetic protocol, compared to this single reference protocol, on the incidence at 3 months post-intervention of Chronic Post-Surgical Pain, in patients operated for a mastectomy with reconstruction immediate by latissimus dorsi flap.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women patient over 18 years-old
- •Patient scheduled for a mastectomy with immediate reconstruction by latissimus dorsi flap with or without symmetrization on the contralateral breast.
- •Patient affiliated or beneficiary of a social security scheme.
- •Patient who has given her free and informed consent.
- •Preoperative blood test showing no contraindication to the operation.
排除标准
- •Refusal of the patient.
- •No indication for auriculotherapy:
- •Patient having a heavy treatment with neuroleptics,
- •Or tricyclic antidepressants which interfere with the action of auriculotherapy.
- •Patient undergoing long-term morphine treatment for chronic pain.
- •Patient with unweaned opioid addiction.
- •Chronic painful patient.
- •Protected patient: Major under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision; Hospitalized without consent.
- •Pregnant, breastfeeding or parturient woman.
- •Patient participating in another interventional study.
- •Patient who had already participated in this study as part of first breast surgery.
- •Patient receiving regular care by auriculotherapy
研究组 & 干预措施
Patient with placebo
Mastectomy operated patient then, they received placebo
干预措施: Chronic Post-Surgical Pain evaluation (Behavioral)
Patients with auriculotherapy
Mastectomy operated patient then, auriculotherapy
干预措施: Auriculotherapy (Drug)
Patients with auriculotherapy
Mastectomy operated patient then, auriculotherapy
干预措施: Chronic Post-Surgical Pain evaluation (Behavioral)
结局指标
主要结局
Presence, or not, of Chronic Post-Surgical Pain (DCPC)
时间窗: 3 months
DCPC noted during the clinical examination of the 3rd postoperative month : \- score obtained at BPI : Brief Pain Inventory (9 items : many items with answers between 0 and 10)
次要结局
未报告次要终点