Ignite Creation Date:
2025-12-25 @ 1:06 AM
Ignite Modification Date:
2026-02-08 @ 9:51 PM
Study NCT ID:
NCT02408393
Status:
COMPLETED
Last Update Posted:
2019-07-10
First Post:
2015-03-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
MIRs03: Paravertebral Block With Ropivacaine Before Breast Cancer Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D059350', 'term': 'Chronic Pain'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D012965', 'term': 'Sodium Chloride'}, {'id': 'D000077212', 'term': 'Ropivacaine'}], 'ancestors': [{'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}, {'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 380}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-03-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-07', 'completionDateStruct': {'date': '2019-03-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-07-09', 'studyFirstSubmitDate': '2015-03-17', 'studyFirstSubmitQcDate': '2015-04-02', 'lastUpdatePostDateStruct': {'date': '2019-07-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-04-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To compare chronic pain 3 months after breast surgery in each arm', 'timeFrame': '3 months', 'description': 'Percentage of patients who reported chronic pain 3 months after breast surgery in each arm evaluated by the Brief Pain Inventory, French version. Chronic pain is defined by the item 5 of BPI (upper or equal to 3)'}], 'secondaryOutcomes': [{'measure': 'To measure the extend of dermatomes blocked', 'timeFrame': 'one year after surgery', 'description': 'The extent of dermatomes blocked as measured by clinical examination to determine area where temperature perception change'}, {'measure': 'To measure acute postoperative pain (Visual Analog Scale (VAS)', 'timeFrame': '48 postoperative hours', 'description': 'Patient satisfaction on Visual Analog Scale (VAS)'}, {'measure': 'To determine analgesic consumption', 'timeFrame': '48 postoperative hours', 'description': 'consumption during the first 48 postoperative hours: morphine paracetamol and ketoprofen'}, {'measure': 'To examine incidence of nausea and vomiting', 'timeFrame': '48 postoperative hours', 'description': 'Common Toxicity Criteria for Adverse Effects (CTCAE) V4.03'}, {'measure': 'To characterize chronic pain (Neuropathic Pain Diagnostic DN4 Questionnaire)', 'timeFrame': '3 months', 'description': 'Neuropathic Pain Diagnostic DN4 Questionnaire'}, {'measure': 'To evaluate the frequency of chronic pain (BPI questionnaire and Neuropathic Pain Diagnostic (DN4)', 'timeFrame': '6 and 12 months', 'description': 'BPI questionnaire and Neuropathic Pain Diagnostic (DN4)'}, {'measure': 'To compare presence of lymphedema', 'timeFrame': '3, 6 and 12 months', 'description': 'Clinical examination'}, {'measure': 'To evaluate anxiety and depression evaluation (Hospital Anxiety and Depression questionnaire (HAD)', 'timeFrame': '3, 6 and 12 months', 'description': 'Hospital Anxiety and Depression questionnaire (HAD)'}, {'measure': 'To evaluate complications of paravertebral block (CTCAE V4.03)', 'timeFrame': '12 months', 'description': 'CTCAE V4.03'}, {'measure': 'To determine the number of patients reporting pain at 6 months', 'timeFrame': '6 months', 'description': 'Clinical examination to confirm the results of Visual analog scale, pain scores BPI and DN4'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Surgery', 'Paravertebral block', 'Chronic pain'], 'conditions': ['Malignant Neoplasm of Breast']}, 'referencesModule': {'references': [{'pmid': '23340346', 'type': 'RESULT', 'citation': 'Cohen 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': '23340351', 'type': 'RESULT', 'citation': 'Albi-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': '19903919', 'type': 'RESULT', 'citation': 'Gartner 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': '16698416', 'type': 'RESULT', 'citation': 'Kehlet 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': '11020770', 'type': 'RESULT', 'citation': 'Perkins 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.'}]}, 'descriptionModule': {'briefSummary': 'Compare the effect of paravertebral block (PVB) with Ropivacaine or placebo on the incidence of chronic pain 3 months after breast cancer surgery.', 'detailedDescription': '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.\n\nEvaluation 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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Women with non-metastatic invasive breast carcinoma or breast carcinoma in situ treated by:\n\n * either breast-conserving surgery with axillary lymph node dissection\n * either radical surgery with or without axillary lymph node dissection.\n2. 18 years ≤ Age ≥ 85 years.\n3. ASA class 1, 2 or 3.\n4. No analgesic treatment for 2 days (no pre-existing chronic pain)\n5. 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)\n6. Life expectancy ≥ 2 years.\n7. Signed informed consent form.\n8. Patient able to meet the self-assessments questionnaires (sufficient understanding assessments, proficiency in French)\n9. Patient affiliated with a health insurance scheme (beneficiary or legal)\n\nThere 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.\n\nExclusion Criteria:\n\n1. 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.\n2. Bilateral breast carcinoma at the inclusion\n3. Male subjects.\n4. Metastatic breast carcinoma at diagnosis (M1).\n5. Severe heart, liver and respiratory failure (ASA 4)\n6. Allergy to local anesthetics and morphine.\n7. Use of analgesics during the 48 hours preceding the surgical procedure.\n8. History of breast surgery with painful sequelae\n9. Major deformation of the spine\n10. Puncture site infection\n11. History of substance abuse.\n12. Pregnant or lactating women, or women of childbearing potential without effective contraception\n13. Subjects deprived of their liberty or under guardianship (including temporary guardianship).\n14. Subjects unable to comply with medical follow-up of the trial for geographical, social or psychological reasons.'}, 'identificationModule': {'nctId': 'NCT02408393', 'acronym': 'MIRs03', 'briefTitle': 'MIRs03: Paravertebral Block With Ropivacaine Before Breast Cancer Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Institut Curie'}, 'officialTitle': 'MIRs03: A Double-blind Randomized Trial of Paravertebral Block With Ropivacaine Before Breast Cancer Surgery: Effects on Chronic Postoperative Pain', 'orgStudyIdInfo': {'id': 'IC 2014-07'}}, 'armsInterventionsModule': {'armGroups': [{'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']}], 'interventions': [{'name': 'Saline', 'type': 'DRUG', 'otherNames': ['NA Cl 0.9%'], 'armGroupLabels': ['Placebo']}, {'name': 'Ropivacaine', 'type': 'DRUG', 'otherNames': ['Naropeine'], 'armGroupLabels': ['Ropivacaine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '63011', 'city': 'Clermont-Ferrand', 'country': 'France', 'facility': 'Centre Jean PERRIN', 'geoPoint': {'lat': 45.77969, 'lon': 3.08682}}, {'zip': '69008', 'city': 'Lyon', 'country': 'France', 'facility': 'Centre Léon Bérard', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'zip': '06189 NICE Cedex', 'city': 'Nice', 'country': 'France', 'facility': 'Centre Antoine LACASSAGNE', 'geoPoint': {'lat': 43.70313, 'lon': 7.26608}}, {'zip': '75005', 'city': 'Paris', 'country': 'France', 'facility': 'INSTITUT CURIE - Site Paris', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '92210', 'city': 'Saint-Cloud', 'country': 'France', 'facility': 'Institut Curie site Saint-Cloud', 'geoPoint': {'lat': 48.84598, 'lon': 2.20289}}, {'zip': '54511', 'city': 'Vandœuvre-lès-Nancy', 'country': 'France', 'facility': 'Institut de Cancérologie de Lorraine', 'geoPoint': {'lat': 48.66115, 'lon': 6.17114}}], 'overallOfficials': [{'name': 'Pierre FUMOLEAU, PHD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'drci.promotion@curie.fr'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institut Curie', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}