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

NCT05126615 | Terminated

• 1 other identifier: 2018-A01108-47
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Mastectomy; Auriculotherapy

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Patients with auriculotherapy

EXPERIMENTAL

Mastectomy operated patient then, auriculotherapy

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

Patient with placebo

PLACEBO COMPARATOR

Mastectomy operated patient then, they received placebo

Behavioral: Chronic Post-Surgical Pain evaluation

Interventions

Auriculotherapy DRUG

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.

Patients with auriculotherapy

Chronic Post-Surgical Pain evaluation BEHAVIORAL

Different questionnaires : BPI : Brief Pain Inventory DN4

Patient with placebo; Patients with auriculotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Ramsay Générale de Santé: lead

Study Sites (1)

Hôpital Privé Paul d'Egine

Champigny-sur-Marne, 94500, France

Location

MeSH Terms

Interventions

Auriculotherapy

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 9, 2021
• First Posted: November 19, 2021
• Study Start: May 10, 2019
• Primary Completion: August 6, 2021
• Study Completion: September 17, 2021
• Last Updated: November 19, 2021

Record last verified: 2021-11

Locations

FR (1)