Mastectomy Clinical Trial
— PECSOfficial title:
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.
Verified date | November 2022 |
Source | Centre Oscar Lambret |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 194 |
Est. completion date | August 22, 2019 |
Est. primary completion date | February 22, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
France | Centre Oscar Lambret | Lille |
Lead Sponsor | Collaborator |
---|---|
Centre Oscar Lambret |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | 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 | |
Primary | 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 | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | Intensity of chronic pain | The intensity of the pain will be recorded using the visual analog scale (VAS). | 6 and 12 month after surgery | |
Secondary | predictive factors of survival | Using the proportional hazards model. | an average of 1 year | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | Depression assessed with the HADS questionnaire | HADS (Hospital Anxiety and Depression Scale) : to detect anxiety and depression | an average of 1 year |
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