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Clinical Trial 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.

Clinical Trial 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). ;

Study Design

Related Conditions & MeSH terms

NCT number NCT03912948
Study type Observational
Source Institut Claudius Regaud
Contact Régis Fuzier, MD
Phone +33531155347
Status Recruiting
Start date April 1, 2019
Completion date December 31, 2019

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