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

Centre Oscar Lambret

Status: Completed

Conditions: Mastectomy; Breastcancer

Treatments: Procedure: Loco-regional anaesthesia

Study type: Interventional

Funder types: Other

Identifiers

NCT03023007

N°IdRCB : N°2016-A00562-49 (Other Identifier)

PECS-1601

Details and patient eligibility

About

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.

Full 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.

Enrollment: 194 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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194 participants in 1 patient group

Loco-regional anaesthesia

Experimental group

Description:

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

Treatment:

Procedure: Loco-regional anaesthesia