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Spots Global Cancer Trial Database for MIRs03: Paravertebral Block With Ropivacaine Before Breast Cancer Surgery

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Trial Identification

Brief Title: MIRs03: Paravertebral Block With Ropivacaine Before Breast Cancer Surgery

Official Title: MIRs03: A Double-blind Randomized Trial of Paravertebral Block With Ropivacaine Before Breast Cancer Surgery: Effects on Chronic Postoperative Pain

Study ID: NCT02408393

Interventions

Saline
Ropivacaine

Study Description

Brief Summary: Compare the effect of paravertebral block (PVB) with Ropivacaine or placebo on the incidence of chronic pain 3 months after breast cancer surgery.

Detailed Description: Before anesthesia, the second or third intercostal space is located. After an aspiration, 0.35 mL/kg of solution (ropivacaine 7.5 mg/mL or saline, maximum 30 mL) are injected into the paravertebral space. After 30 minutes, spread of PVB is evaluated by cold test on skin. Then, general anesthesia is induced. Evaluation of the frequency of chronic pain at 3, 6 and 12 months by the Brief Pain Inventory (BPI) questionnaire and Neuropathic Pain Diagnostic (DN4) and Anxiety and depression evaluation by the Hospital Anxiety and Depression questionnaire (HAD) will be done.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: FEMALE

Healthy Volunteers: No

Locations

Centre Jean PERRIN, Clermont Ferrand, , France

Centre Léon Bérard, Lyon, , France

Centre Antoine LACASSAGNE, Nice, , France

INSTITUT CURIE - Site Paris, Paris, , France

Institut Curie site Saint-Cloud, Saint Cloud, , France

Institut de Cancérologie de Lorraine, Vandoeuvre-les-nancy, , France

Contact Details

Name: Pierre FUMOLEAU, PHD

Affiliation: drci.promotion@curie.fr

Role: STUDY_DIRECTOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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