Clinical trial · Interventional
MIRs03: Paravertebral Block With Ropivacaine Before Breast Cancer Surgery
MIRs03: A Double-blind Randomized Trial of Paravertebral Block With Ropivacaine Before Breast Cancer Surgery: Effects on Chronic Postoperative Pain
NCT02408393CI-TRIAL-00039425MIRs03completedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Compare the effect of paravertebral block (PVB) with Ropivacaine or placebo on the incidence of chronic pain 3 months after breast cancer surgery.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Malignant Neoplasm of Breast | Malignant Breast Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ropivacaine | Drug | — | UNRESOLVED |
| Saline | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- Saline (30 mL maximum)
- interventionNames
- Drug: Saline
- type
- EXPERIMENTAL
- label
- Ropivacaine
- description
- Ropivacaine 7.5 mg/mL (0.35 mL/kg of solution)
- interventionNames
- Drug: Ropivacaine
Primary outcomes (1)
- measure
- To compare chronic pain 3 months after breast surgery in each arm
- timeFrame
- 3 months
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 85 Years
Show eligibility criteria text
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.
References
Publications (5)
- RESULTCohen SP, Raja SN. Prevention of chronic postsurgical pain: the ongoing search for the holy grail of anesthesiology. Anesthesiology. 2013 Feb;118(2):241-3. doi: 10.1097/ALN.0b013e31827d4129. No abstract available. PMID 23340346
- RESULTAlbi-Feldzer A, Mouret-Fourme E E, Hamouda S, Motamed C, Dubois PY, Jouanneau L, Jayr C. A double-blind randomized trial of wound and intercostal space infiltration with ropivacaine during breast cancer surgery: effects on chronic postoperative pain. Anesthesiology. 2013 Feb;118(2):318-26. doi: 10.1097/ALN.0b013e31827d88d8. PMID 23340351
- RESULTGartner R, Jensen MB, Nielsen J, Ewertz M, Kroman N, Kehlet H. Prevalence of and factors associated with persistent pain following breast cancer surgery. JAMA. 2009 Nov 11;302(18):1985-92. doi: 10.1001/jama.2009.1568. PMID 19903919
- RESULTKehlet H, Jensen TS, Woolf CJ. Persistent postsurgical pain: risk factors and prevention. Lancet. 2006 May 13;367(9522):1618-25. doi: 10.1016/S0140-6736(06)68700-X. PMID 16698416
- RESULTPerkins FM, Kehlet H. Chronic pain as an outcome of surgery. A review of predictive factors. Anesthesiology. 2000 Oct;93(4):1123-33. doi: 10.1097/00000542-200010000-00038. No abstract available. PMID 11020770