Contribution of Auriculotherapy in the Management of Mastectomy With Immediate Reconstruction by Latissimus Dorsi Flap (ATMAGD)

Study Overview
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Brief Summary
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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.

Official Title
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Contribution of Auriculotherapy in the Management of Mastectomy With Immediate Reconstruction by Latissimus Dorsi Flap (ATMAGD)

Conditions
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Mastectomy, Auriculotherapy

Intervention / Treatment
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* Drug: Auriculotherapy
* Behavioral: Chronic Post-Surgical Pain evaluation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patients with auriculotherapy<br>Mastectomy operated patient then, auriculotherapy | Drug: Auriculotherapy<br>* Application of a bolus of 5 μ of liquid nitrogen via a cryospray on the auriculotherapy points A4, C18, D9, C9, DIX, H13, G14 and FXVII, chosen according to a neurophysiological reasoning taking into account the surgical intervention performed and innervation of the anatomical region affected by the intervention.<br>Behavioral: Chronic Post-Surgical Pain evaluation<br>* Different questionnaires : BPI : Brief Pain Inventory DN4<br>|
| Placebo Comparator: Patient with placebo<br>Mastectomy operated patient then, they received placebo | Behavioral: Chronic Post-Surgical Pain evaluation<br>* Different questionnaires : BPI : Brief Pain Inventory DN4<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Presence, or not, of Chronic Post-Surgical Pain (DCPC) | 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) | 3 months | 
| Presence, or not, of Chronic Post-Surgical Pain (DCPC) | DCPC noted during the clinical examination of the 3rd postoperative month : - score obtained at DN4 (neuropathic pain) : 4 different items | 3 months |