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

Ramsay Générale de Santé

Status: Terminated

Conditions: Mastectomy; Auriculotherapy

Treatments: Drug: Auriculotherapy; Behavioral: Chronic Post-Surgical Pain evaluation

Study type: Interventional

Funder types: Other

Identifiers

NCT05126615

2018-A01108-47

Details and patient eligibility

About

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.

Enrollment: 10 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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10 participants in 2 patient groups, including a placebo group

Patients with auriculotherapy

Experimental group

Description:

Mastectomy operated patient then, auriculotherapy

Treatment:

Behavioral: Chronic Post-Surgical Pain evaluation

Drug: Auriculotherapy

Patient with placebo

Placebo Comparator group

Description:

Mastectomy operated patient then, they received placebo

Treatment:

Behavioral: Chronic Post-Surgical Pain evaluation