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| ID | Type | Description | Link |
|---|---|---|---|
| N°IdRCB : N°2016-A00562-49 | Other Identifier | ANSM |
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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Loco-regional anaesthesia | Experimental | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Loco-regional anaesthesia | Procedure | Loco-regional anaesthesia |
|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Prediction of the post-operative chronic pain with Kalkman score | The Kalkman score is a validated risk scale based on patient's history and the type of surgery | within the 15 days before the surgery |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Abesse AHMEIDI, MD | Département Anesthésie /Algologie, Centre Oscar Lambret | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Oscar Lambret | Lille | 59020 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37280082 | Derived | Garcia V, Wallet J, Leroux-Bromberg N, Delbrouck D, Hannebicque K, Ben Oune F, Leguillette C, Le Deley MC, Ahmeidi A. Incidence and characteristics of chronic postsurgical pain at 6 months after total mastectomy under pectoserratus and interpectoral plane block combined with general anesthesia: a prospective cohort study. Reg Anesth Pain Med. 2024 Jan 11;49(1):36-40. doi: 10.1136/rapm-2022-104185. |
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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 |