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

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.

Study Overview

• Status: Terminated
• Conditions: Mastectomy; Auriculotherapy
• Intervention / Treatment: Drug: Auriculotherapy; Behavioral: Chronic Post-Surgical Pain evaluation

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Champigny-sur-Marne, France, 94500
    • Hopital Prive Paul d'Egine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Patients with auriculotherapy; Mastectomy operated patient then, auriculotherapy	Drug: Auriculotherapy; 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.; Behavioral: Chronic Post-Surgical Pain evaluation; Different questionnaires : BPI : Brief Pain Inventory DN4
Placebo Comparator: Patient with placebo; Mastectomy operated patient then, they received placebo	Behavioral: Chronic Post-Surgical Pain evaluation; Different questionnaires : BPI : Brief Pain Inventory DN4

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Ramsay Générale de Santé

Study record dates

Study Major Dates

• Study Start (Actual): May 10, 2019
• Primary Completion (Actual): August 6, 2021
• Study Completion (Actual): September 17, 2021

Study Registration Dates

• First Submitted: November 9, 2021
• First Submitted That Met QC Criteria: November 18, 2021
• First Posted (Actual): November 19, 2021

Study Record Updates

• Last Update Posted (Actual): November 19, 2021
• Last Update Submitted That Met QC Criteria: November 18, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: 2018-A01108-47

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No