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

Study Overview
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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.

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.

Official Title
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Study Evaluating the Efficacy of Loco-regional Anaesthesia PECS on the Rate of Chronic Pains 6 Month After a Mastectomy Associated or Not With Axillary Node Dissection and/or a Reconstruction Prosthesis.

Conditions
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Breastcancer, Mastectomy

Intervention / Treatment
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* Procedure: Loco-regional anaesthesia


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Loco-regional anaesthesia<br>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 | Procedure: Loco-regional anaesthesia<br>* Loco-regional anaesthesia<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of chronic pain | The rate of chronic pain will be assessed in percentage (%) based on the criteria of the International Association for the Study Pain (IASP) during an algology medical consultation. | 6 month after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acute post-operative pain | A representation of the trajectory of pain in the 3 days will be drawn. This pain trajectory is defined as the kinetics of the average daily visual analog scale (VAS) score for 3 days. | During the 3 days following the surgery | 
| Side effects post-operative | All side effects (e.g. nausea, vomiting etc.) will be recorded, with its date, time, severity, relation with the treatment, treatment associated and evolution. The intensity of adverse events will be scored using the criteria from NCI-CTCAE version 4.0. | During the 3 days following the surgery | 
| Rate of chronic pain | Assessed based on the criteria of the International Association for the Study Pain (IASP) collected via telephone call. | 12 month after the surgery | 
| Type of chronic pain | The type of chronic pain will be determined using the DN4 score. The DN4 score is a form used for the diagnostic of neuropathic pain. | 6 and 12 month after surgery | 
| Intensity of chronic pain | The intensity of the pain will be recorded using the visual analog scale (VAS). | 6 and 12 month after surgery | 
| predictive factors of survival | Using the proportional hazards model. | an average of 1 year | 
| Quality of life of the patient assessed with the QLQ-C30 questionnaire | QLQ-C30 from the EORTC (quality of life in general, physical condition, limitations to activities, cognitive functions, emotional and social and symptoms occurrences related to cancer or the treatment) | an average of 1 year | 
| Quality of life of the patient assessed with the QLQ-BR23 questionnaire | QLQ-BR23 (body image, perception of the future etc. and side effects) | an average of 1 year | 
| Depression assessed with the HADS questionnaire | HADS (Hospital Anxiety and Depression Scale) : to detect anxiety and depression | an average of 1 year |