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

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.

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.

Study Overview

• Status: Completed
• Conditions: Breastcancer; Mastectomy
• Intervention / Treatment: Procedure: Loco-regional anaesthesia

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.

• Study Type: Interventional
• Enrollment (Actual): 194
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Lille, France, 59020
    • Centre Oscar Lambret

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Loco-regional anaesthesia; 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	Procedure: Loco-regional anaesthesia; Loco-regional anaesthesia

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Other Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Centre Oscar Lambret
• Investigators: Study Director: Abesse AHMEIDI, MD, Département Anesthésie /Algologie, Centre Oscar Lambret

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 3, 2017
• Primary Completion (ACTUAL): February 22, 2019
• Study Completion (ACTUAL): August 22, 2019

Study Registration Dates

• First Submitted: January 10, 2017
• First Submitted That Met QC Criteria: January 13, 2017
• First Posted (ESTIMATE): January 18, 2017

Study Record Updates

• Last Update Posted (ACTUAL): November 21, 2022
• Last Update Submitted That Met QC Criteria: November 18, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Pain; Neurologic Manifestations; Breast Diseases; Breast Neoplasms; Chronic Pain; Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics
• Other Study ID Numbers: PECS-1601; N°IdRCB : N°2016-A00562-49 (OTHER: ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No