Clinical trial NCT03023007: Study Evaluating the Efficacy of Loco-regional Anaesthesia PECS on Chronic Pain of a Mastectomy
Official 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breastcancer
Mastectomy
Lead sponsor: Centre Oscar Lambret
Sponsor class: OTHER
First posted: 2017-01-18
Enrollment: 194
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Rate of chronic pain
timeFrame: 6 month after surgery
Secondary outcomes:
measure: Acute post-operative pain
timeFrame: During the 3 days following the surgery
measure: Side effects post-operative
timeFrame: During the 3 days following the surgery
measure: Rate of chronic pain
timeFrame: 12 month after the surgery
measure: Type of chronic pain
timeFrame: 6 and 12 month after surgery
measure: Intensity of chronic pain
timeFrame: 6 and 12 month after surgery
measure: predictive factors of survival
timeFrame: an average of 1 year
measure: Quality of life of the patient assessed with the QLQ-C30 questionnaire
timeFrame: an average of 1 year
measure: Quality of life of the patient assessed with the QLQ-BR23 questionnaire
timeFrame: an average of 1 year
measure: Depression assessed with the HADS questionnaire
timeFrame: an average of 1 year
Other outcomes:
measure: Prediction of the post-operative chronic pain with Kalkman score
timeFrame: within the 15 days before the surgery
Locations:
city: Lille
country: France
facility: Centre Oscar Lambret
Study officials:
affiliation: Département Anesthésie /Algologie, Centre Oscar Lambret
name: Abesse AHMEIDI, MD
role: STUDY_DIRECTOR
References: