Breastcancer, Mastectomy
Conditions
Brief summary
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
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.
Interventions
PROCEDURELoco-regional anaesthesia
Loco-regional anaesthesia
Sponsors
Centre Oscar Lambret
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of chronic pain | 6 month after surgery | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Acute post-operative pain | During the 3 days following the surgery | 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. |
| Side effects post-operative | During the 3 days following the surgery | 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. |
| Rate of chronic pain | 12 month after the surgery | Assessed based on the criteria of the International Association for the Study Pain (IASP) collected via telephone call. |
| Type of chronic pain | 6 and 12 month after surgery | 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. |
| Intensity of chronic pain | 6 and 12 month after surgery | The intensity of the pain will be recorded using the visual analog scale (VAS). |
| predictive factors of survival | an average of 1 year | Using the proportional hazards model. |
| Quality of life of the patient assessed with the QLQ-C30 questionnaire | an average of 1 year | 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) |
| Quality of life of the patient assessed with the QLQ-BR23 questionnaire | an average of 1 year | QLQ-BR23 (body image, perception of the future etc. and side effects) |
| Depression assessed with the HADS questionnaire | an average of 1 year | HADS (Hospital Anxiety and Depression Scale) : to detect anxiety and depression |
Countries
France
Contacts
STUDY_DIRECTORAbesse AHMEIDI, MD
Département Anesthésie /Algologie, Centre Oscar Lambret
Outcome results
None listed