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

Primary Purpose

Breastcancer, Mastectomy

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Loco-regional anaesthesia
Sponsored by
Centre Oscar Lambret
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breastcancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Centre Oscar Lambret

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Loco-regional anaesthesia

Arm 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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
Rate of chronic pain
Assessed based on the criteria of the International Association for the Study Pain (IASP) collected via telephone call.
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.
Intensity of chronic pain
The intensity of the pain will be recorded using the visual analog scale (VAS).
predictive factors of survival
Using the proportional hazards model.
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)
Quality of life of the patient assessed with the QLQ-BR23 questionnaire
QLQ-BR23 (body image, perception of the future etc. and side effects)
Depression assessed with the HADS questionnaire
HADS (Hospital Anxiety and Depression Scale) : to detect anxiety and depression

Full Information

First Posted
January 10, 2017
Last Updated
November 18, 2022
Sponsor
Centre Oscar Lambret
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1. Study Identification

Unique Protocol Identification Number
NCT03023007
Brief Title
Study Evaluating the Efficacy of Loco-regional Anaesthesia PECS on Chronic Pain of a Mastectomy
Acronym
PECS
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

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
April 3, 2017 (Actual)
Primary Completion Date
February 22, 2019 (Actual)
Study Completion Date
August 22, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Oscar Lambret

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breastcancer, Mastectomy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
194 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Loco-regional anaesthesia
Arm Type
Experimental
Arm 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
Intervention Type
Procedure
Intervention Name(s)
Loco-regional anaesthesia
Intervention Description
Loco-regional anaesthesia
Primary Outcome Measure Information:
Title
Rate of chronic pain
Description
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 Outcome Measure Information:
Title
Acute post-operative pain
Description
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
Title
Side effects post-operative
Description
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
Title
Rate of chronic pain
Description
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
Title
Type of chronic pain
Description
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
Title
Intensity of chronic pain
Description
The intensity of the pain will be recorded using the visual analog scale (VAS).
Time Frame
6 and 12 month after surgery
Title
predictive factors of survival
Description
Using the proportional hazards model.
Time Frame
an average of 1 year
Title
Quality of life of the patient assessed with the QLQ-C30 questionnaire
Description
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)
Time Frame
an average of 1 year
Title
Quality of life of the patient assessed with the QLQ-BR23 questionnaire
Description
QLQ-BR23 (body image, perception of the future etc. and side effects)
Time Frame
an average of 1 year
Title
Depression assessed with the HADS questionnaire
Description
HADS (Hospital Anxiety and Depression Scale) : to detect anxiety and depression
Time Frame
an average of 1 year
Other Pre-specified Outcome Measures:
Title
Prediction of the post-operative chronic pain with Kalkman score
Description
The Kalkman score is a validated risk scale based on patient's history and the type of surgery
Time Frame
within the 15 days before the surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Abesse AHMEIDI, MD
Organizational Affiliation
Département Anesthésie /Algologie, Centre Oscar Lambret
Official's Role
Study Director
Facility Information:
Facility Name
Centre Oscar Lambret
City
Lille
ZIP/Postal Code
59020
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

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

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