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MIRs03: Paravertebral Block With Ropivacaine Before Breast Cancer Surgery

CompletedPhase 3NCT02408393
View the official record on ClinicalTrials.gov

Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.

This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.

Brief summary (from the registry)

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

Study details

Official title
MIRs03: A Double-blind Randomized Trial of Paravertebral Block With Ropivacaine Before Breast Cancer Surgery: Effects on Chronic Postoperative Pain
Conditions
  • Malignant Neoplasm of Breast
Sponsor
Institut Curie
Start date
2015-03-27
Primary completion
2018-07
Sex
Female
Age range
from 18 Years to 85 Years
Results posted
No results posted in this snapshot
Countries
France
Total sites listed
6

Eligibility criteria

Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: 1. Women with non-metastatic invasive breast carcinoma or breast carcinoma in situ treated by: * either breast-conserving surgery with axillary lymph node dissection * either radical surgery with or without axillary lymph node dissection. 2. 18 years ≤ Age ≥ 85 years. 3. ASA class 1, 2 or 3. 4. No analgesic treatment for 2 days (no pre-existing chronic pain) 5. If a biological control has been requested recently or deemed necessary by the Investigator, then it should be satisfactory : Adequate hematologic and hemostasis: neutrophil count (ANC) \> 1500/mm3, haemoglobin \> 9 g/dl and platelets \> 75 000/mm3, prothrombin time \> 70%, activated partial thromboplastin time \< 1.5 X Upper Limit of Normal (ULN) 6. Life expectancy ≥ 2 years. 7. Signed informed consent form. 8. Patient able to meet the self-assessments questionnaires (sufficient understanding assessments, proficiency in French) 9. Patient affiliated with a health insurance scheme (beneficiary or legal) There is no prohibition for people to take part simultaneously in another search and there is no exclusion cause at the end of the research period. Exclusion Criteria: 1. Ongoing neoplasm or history of malignancy other than breast cancer with the exception of: basal cell carcinoma, cervical carcinoma in situ, other treated cancer that has not relapsed during the 5 years preceding inclusion in the trial. 2. Bilateral breast carcinoma at the inclusion 3. Male subjects. 4. Metastatic breast carcinoma at diagnosis (M1). 5. Severe heart, liver and respiratory failure (ASA 4) 6. Allergy to local anesthetics and morphine. 7. Use of analgesics during the 48 hours preceding the surgical procedure. 8. History of breast surgery with painful sequelae 9. Major deformation of the spine 10. Puncture site infection 11. History of substance abuse. 12. Pregnant or lactating women, or women of childbearing potential without effective contraception 13. Subjects deprived of their liberty or under guardianship (including temporary guardianship). 14. Subjects unable to comply with medical follow-up of the trial for geographical, social or psychological reasons.

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT02408393