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NCT Number: NCT03023007

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

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.

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Key information

Conditions

Breastcancer Mastectomy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre Oscar Lambret

Lille, 59020, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Loco-regional anaesthesia

Procedure

Loco-regional anaesthesia

Primary outcomes

  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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Centre Oscar Lambret

Other

Registry information

Official study 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.

Acronym: PECS

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Jan 18, 2017
Registry last updated
Mar 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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