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

Not Applicable

Terminated

• Conditions: Mastectomy; Auriculotherapy
• Interventions: Behavioral: Chronic Post-Surgical Pain evaluation; Drug: Auriculotherapy

• Registration Number: NCT05126615
• Lead Sponsor: Ramsay Générale de Santé

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-05-10
• Primary Completion: 2021-08-06
• Study Completion: 2021-09-17
• Status Verified: 2021-11
• Study First Submitted: 2021-11-09
• Study First Submitted QC: 2021-11-18
• Last Update Submitted: 2021-11-18
• Study First Posted: 2021-11-19
• Last Update Posted: 2021-11-19

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Patient with placebo	Chronic Post-Surgical Pain evaluation	Mastectomy operated patient then, they received placebo
Patients with auriculotherapy	Auriculotherapy	Mastectomy operated patient then, auriculotherapy
Patients with auriculotherapy	Chronic Post-Surgical Pain evaluation	Mastectomy operated patient then, auriculotherapy

Primary Outcome Measures

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

Trial Locations

Locations (1)

Hôpital Privé Paul d'Egine; 🇫🇷 Champigny-sur-Marne, France