Study Evaluating the Efficacy of Loco-regional Anaesthesia PECS on Chronic Pain of a Mastectomy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

194 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-03

Study Completion Date

2019-08-22

Brief Summary

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A non-randomized, mono-centric, prospective interventional study that will assess the efficacy of the loco-regional anesthesia PECS on the rate of chronic pain, 6 month after a patient will have either received a mastectomy or a mastectomy associated with axillary nodes dissection, and/or a reconstruction by prosthesis.

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Detailed Description

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The aim of this study is to assess the care given to treat breast cancer while the patient receives a total mastectomy. It is done by evaluating the technique of anesthesia PECS used during this procedure so that the rate of chronic pain can be measured 6 month after the operation.

As well as total mastectomy, patients are also eligible for an axillary lymph node dissection (ALND) and a reconstruction of the breast by prosthesis as options.

Other objectives of the study include:

* Evaluating the effectiveness of the PECS anesthesia technique on the trajectory of acute post-operative pain and on chronic pain after 12 month of the surgery
* Evaluating the type and intensity of the pain
* Evaluating the quality of life
* Study the link between chronic pain and the trajectory of acute pain.

Conditions

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Breastcancer Mastectomy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Loco-regional anaesthesia

Loco-regional anaesthesia Anesthesia technique used : loco-regional PECS for patients requiring Mastectomy; And/or Axillary node dissection ; And/or Reconstruction of breast by prosthesis

Group Type EXPERIMENTAL

Loco-regional anaesthesia

Intervention Type PROCEDURE

Loco-regional anaesthesia

Interventions

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Loco-regional anaesthesia

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Patients with unilateral breast cancer
* Surgery must be a total mastectomy +/- axillary lymph node dissection and +/- reconstruction by prosthesis; unless first surgery was performed more than 5 years prior to total mastectomy without any residual pain
* Age ≥ 18 ans
* Non-opposition of patients

Exclusion Criteria

* Reconstruction by other than prosthesis
* Previous breast surgery in the last year
* Hypersensitivity or allergy of anaesthetics
* Coagulopathy and local infections
* Pregnant or breastfeeding
* Patients under guardianship

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No