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
|Condition or disease|
|Surgery Breast Cancer Pain, Postoperative Pain, Chronic|
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 Type :||Observational|
|Estimated Enrollment :||83 participants|
|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|
- Prevalence of chronic pain [ Time Frame: 3 months ]To assess the number (%) of patients presenting persistent pain 3 months after minor breast cancer surgery
- 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.
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
|Contact: Régis Fuzier, MDemail@example.com|
|Contact: Anne-laure Fize, MScfirstname.lastname@example.org|
|Institut Claudius Regaud - IUCT-Oncopole||Recruiting|
|Toulouse, Occitanie, France, 31059 cedex 09|
|Contact: Anne-Laure Fize, MSc +33531155059 email@example.com|
|Principal Investigator: Régis Fuzier, MD|