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

Mastectomy Clinical Trial

— ATMAGD  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05126615
• Other study ID #: 2018-A01108-47
• Status: Terminated
• Phase: N/A
• Start date: May 10, 2019
• Est. completion date: September 17, 2021

Study information

• Verified date: November 2021
• Source: Ramsay Générale de Santé
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 10
• Est. completion date: September 17, 2021
• Est. primary completion date: August 6, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Mastectomy

Intervention

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

Locations

Country	Name	City	State
France	Hôpital Privé Paul d'Egine	Champigny-sur-Marne

Sponsors (1)

Lead Sponsor	Collaborator
Ramsay Générale de Santé

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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