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

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ClinicalTrials.gov Identifier: NCT03023007
Recruitment Status : Completed
First Posted : January 18, 2017
Last Update Posted : March 5, 2020
Sponsor:
Information provided by (Responsible Party):
Centre Oscar Lambret

Study Description
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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.

Condition or disease Intervention/treatment Phase
Breastcancer Mastectomy Procedure: Loco-regional anaesthesia Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 194 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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.
Actual Study Start Date : March 30, 2017
Actual Primary Completion Date : August 22, 2018
Actual Study Completion Date : August 27, 2019

Resource links provided by the National Library of Medicine


Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Rate of chronic pain [ Time Frame: 6 month after surgery ]
    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 :
  1. Acute post-operative pain [ Time Frame: During the 3 days following the surgery ]
    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.

  2. Side effects post-operative [ Time Frame: During the 3 days following the surgery ]
    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.

  3. Rate of chronic pain [ Time Frame: 12 month after the surgery ]
    Assessed based on the criteria of the International Association for the Study Pain (IASP) collected via telephone call.

  4. Type of chronic pain [ Time Frame: 6 and 12 month after surgery ]
    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.

  5. Intensity of chronic pain [ Time Frame: 6 and 12 month after surgery ]
    The intensity of the pain will be recorded using the visual analog scale (VAS).

  6. predictive factors of survival [ Time Frame: an average of 1 year ]
    Using the proportional hazards model.

  7. Quality of life of the patient assessed with the QLQ-C30 questionnaire [ Time Frame: an average of 1 year ]
    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)

  8. Quality of life of the patient assessed with the QLQ-BR23 questionnaire [ Time Frame: an average of 1 year ]
    QLQ-BR23 (body image, perception of the future etc. and side effects)

  9. Depression assessed with the HADS questionnaire [ Time Frame: an average of 1 year ]
    HADS (Hospital Anxiety and Depression Scale) : to detect anxiety and depression


Other Outcome Measures:
  1. Prediction of the post-operative chronic pain with Kalkman score [ Time Frame: within the 15 days before the surgery ]
    The Kalkman score is a validated risk scale based on patient's history and the type of surgery


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03023007


Locations
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France
Centre Oscar Lambret
Lille, France, 59020
Sponsors and Collaborators
Centre Oscar Lambret
Investigators
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Study Director: Abesse AHMEIDI, MD Département Anesthésie /Algologie, Centre Oscar Lambret
More Information
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Responsible Party: Centre Oscar Lambret
ClinicalTrials.gov Identifier: NCT03023007    
Other Study ID Numbers: PECS-1601
N°IdRCB : N°2016-A00562-49 ( Other Identifier: ANSM )
First Posted: January 18, 2017    Key Record Dates
Last Update Posted: March 5, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Breast Neoplasms
Chronic Pain
Pain
Neurologic Manifestations
Neoplasms by Site
Neoplasms
 Breast Diseases
Skin Diseases
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs