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

Centre Oscar Lambret194 enrolled

Overview

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: * 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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

194

Conditions

Breastcancer Mastectomy

Interventions

Loco-regional anaesthesiaPROCEDURE

Loco-regional anaesthesia

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Centre Oscar Lambret

Lille, France

Outcomes

Primary Outcomes

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.

Time frame: 6 month after surgery

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 6 and 12 month after surgery

Intensity of chronic pain

The intensity of the pain will be recorded using the visual analog scale (VAS).

Time frame: 6 and 12 month after surgery

predictive factors of survival

Data from ClinicalTrials.gov

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