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Chronic Pain and Minor Breast Cancer Surgery (DCPO Sein)

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ClinicalTrials.gov Identifier: NCT03912948
Recruitment Status : Recruiting
First Posted : April 11, 2019
Last Update Posted : April 11, 2019
Sponsor:
Information provided by (Responsible Party):
Institut Claudius Regaud

Brief Summary:
Breast cancer is the most frequent in women. Early diagnosis and recent treatments have improved overall mortality. However, chronic pain (pain lasting more than 3 months after surgery) remains a public health problem with impact on quality of life for these patients. The incidence of pain has been reported up to 25 to 60% of patients in the literature, even many years after a radical mastectomy (Gartner et al. JAMA 2009;302:1985-92). The neuropathic component of the pain is usually underestimated. In a prospective cohort study we have demonstrated that 43% of patient needed on average 5mg of morphine intravenously in the recovery room after a conservative breast cancer surgery, despite a multimodal regimen of analgesic drugs (Fuzier et al. J Anesth 2017;31:246-54). In the same study, 40% of patients reported persistent pain 3 months after the surgery. To improve the analgesia in such a population, we decided to introduce regional analgesia technique (serratus block) systematically. This became our gold standard in our daily practice. We would like to assess the efficacy of such regional analgesia techniques on opioids consumption in the recovery room and the incidence of pain 3 months after conservative breast cancer surgery.

Condition or disease
Surgery Breast Cancer Pain, Postoperative Pain, Chronic

Detailed Description:

this is a prospective observational study assessing the interest of preoperative thoracic block (injection of local anesthetic around the serratus muscle under ultrasound guidance) in the prevalence of chronic pain 3 months after a conservative breast cancer surgery.

Criteria of inclusion included: women >18yrs old, with ASA physical status 1 to 3, with unilateral breast adenocarcinoma treated surgically by conservative tumorectomy ± associated to sentinel lymph node dissection on an ambulatory basis.

Criteria of exclusion included: patients classified as ASA physical status 4 or worse, having undergone surgery to the contralateral breast in the past 3 months, presenting another malignant disease, presenting a metastatic adenocarcinoma of the breast, having undergone previous surgery of the ipsilateral side in the past 3 years, chronic analgesic intake (> 1 month) before the surgery for pain other than that in the breast, incapable of answering the auto-evaluation questionnaire, refusing to participate in the investigation, and not replying to a contact attempt via telephone made to patients who had not returned their questionnaire.

Information on the present survey was given during pre-operative consultation and signed informed consent was obtained to enter the study.

The management of patients undergoing minor surgery for breast cancer is standardized within our department and reported in our previous study (Fuzier et al. J Anesth 2017;31:246-54). After starting the induction of anesthesia and insertion of a laryngeal mask, a regional analgesia technique was performed under ultrasonography. Twenty ml of ropivacaine 3.75mg/ml were injected under the serratus muscle, at the lateral edge of the minor pectoralis muscle. In the absence of contraindications, multimodal analgesia consisted of paracetamol, non-steroidal anti-inflammatory drugs and nefopam. Postoperative intravenous morphine titration was possible in patients presenting a pain score >3/10 (numeric pain intensity scale from 0 = no pain to 10 = maximum imaginable pain) in the recovery room. If 0.1mg/kg of morphine did not permit to alleviate pain, ketamine titration was initiated by the anesthesiologist.

The incidence of patients that required opioids titration in the recovery room (and the dose injected) was recorded.

The questionnaire sent to the patients 3 months after their surgery was mainly composed of closed questions. This questionnaire included pain score, location of pain, analgesic drugs consumption, neuropathic component (self-administered questionnaire derived from the DN4 questionnaire), impact of quality of life using the Brief Pain Inventory).


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Study Type : Observational
Estimated Enrollment : 83 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Cohort Study Assessing Chronic Pain in Patients With Thoracic Blocks Following Minor Surgery for Breast Cancer.
Actual Study Start Date : April 1, 2019
Estimated Primary Completion Date : September 30, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Prevalence of chronic pain [ Time Frame: 3 months ]
    To assess the number (%) of patients presenting persistent pain 3 months after minor breast cancer surgery


Secondary Outcome Measures :
  1. Incidence of pain [ Time Frame: 3 months ]
    incidence of pain and mean dose of morphine injected in the recovery room, percentage of neuropathic component among patients presenting persistent pain at 3 months; impact of pain on quality of life, risk factors to develop postoperative persistent pain.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
women >18yrs old, with ASA physical status 1 to 3, with unilateral breast adenocarcinoma treated surgically by conservative tumorectomy ± associated to sentinel lymph node dissection on an ambulatory basis.
Criteria

Inclusion Criteria:

  • women
  • > 18 years old
  • with ASA physical status 1 to 3
  • with unilateral breast cancecr adenocarcinoma treated surgically by conservative tumorectomy associated or not to sentinel lymph node dissection on an ambulatory basis

Exclusion Criteria:


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): NCT03912948


Contacts
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Contact: Régis Fuzier, MD +33531155347 fuzier.regis@iuct-oncopole.fr
Contact: Anne-laure Fize, MSc +33531155059 fize.annelaure@iuct-oncopole.fr

Locations
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France
Institut Claudius Regaud - IUCT-Oncopole Recruiting
Toulouse, Occitanie, France, 31059 cedex 09
Contact: Anne-Laure Fize, MSc    +33531155059    fize.annelaure@iuct-oncopole.fr   
Principal Investigator: Régis Fuzier, MD         
Sponsors and Collaborators
Institut Claudius Regaud

Study Data/Documents: Web site for patient information on studies bases on patients data (RGPD)  This link exits the ClinicalTrials.gov site

Publications of Results:
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Responsible Party: Institut Claudius Regaud
ClinicalTrials.gov Identifier: NCT03912948     History of Changes
Other Study ID Numbers: CNIL-2033408
First Posted: April 11, 2019    Key Record Dates
Last Update Posted: April 11, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Will not be shared

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Institut Claudius Regaud:
regional analgesia techniques
breast cancer surgery
conservative surgery

Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Chronic Pain
Pain, Postoperative
Skin Diseases
Pain
Neurologic Manifestations
Signs and Symptoms
Postoperative Complications
Pathologic Processes