Ignite Creation Date:
2025-12-25 @ 3:28 AM
Ignite Modification Date:
2025-12-26 @ 2:08 AM
Study NCT ID:
NCT05439005
Status:
RECRUITING
Last Update Posted:
2025-09-19
First Post:
2022-06-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Opioid Free Versus Opioid Based Anaesthesia for Free Flap Reconstruction Surgery of the Breast: A Phase III Multicentric Randomized Controlled Study.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D020927', 'term': 'Dexmedetomidine'}], 'ancestors': [{'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 158}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-12-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2026-03-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-18', 'studyFirstSubmitDate': '2022-06-27', 'studyFirstSubmitQcDate': '2022-06-27', 'lastUpdatePostDateStruct': {'date': '2025-09-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2022-06-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-03-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'comparison of Morphine consumption in the two groups', 'timeFrame': 'during the first 48 hours postoperatively'}], 'secondaryOutcomes': [{'measure': 'Assessment of vasopressor requirement and total intraoperative filling volume', 'timeFrame': 'end of surgery'}, {'measure': 'Assessment of the state of consciousness on arrival in the PACU', 'timeFrame': 'on arrival in the PACU'}, {'measure': 'Assessment of the incidence of PONV in the PACU, at D0, D1 and D2', 'timeFrame': 'in the PACU, at D0, D1 and D2'}, {'measure': 'Maximum VAS at rest and mobilization in the PACU, at D0, D1 and D2', 'timeFrame': 'in the PACU, at D0, D1 and D2'}, {'measure': 'Dose of morphine given in titration in the PACU (mg)', 'timeFrame': 'in the PACU'}, {'measure': 'Number of boluses demand on PCA during the first 48 hours postoperatively', 'timeFrame': 'the first 48 hours postoperatively'}, {'measure': 'DN3 score (Neuropathic Pain 3) on D2, D4, M1, M3 and M6', 'timeFrame': 'on D2, D4, M1, M3 and M6'}, {'measure': 'Length of stay in PACU (h) and length of in-hospital postoperative length of stay (D)', 'timeFrame': 'at discharge'}, {'measure': 'Assessment of the flap failure rate (flap removal surgery) and flap micro-anastomosis re-exploration rate', 'timeFrame': 'at discharge'}, {'measure': 'Pain management satisfaction scores (score from 0 to 10) at discharge', 'timeFrame': 'at discharge'}, {'measure': 'Collection of serious adverse events between D0 (date of surgery) and D30', 'timeFrame': 'between D0 (date of surgery) and D30'}, {'measure': 'Dose of intraoperative rescue remifentanil in the OFA group (mcg)', 'timeFrame': 'at discharge'}, {'measure': 'Morphine consumption during the first 48 hours post-operatively (mg) in each breast reconstruction subgroup (immediate and secondary);', 'timeFrame': 'the first 48 hours postoperatively'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['free flap reconstruction surgery', 'anaesthesia'], 'conditions': ['Breast Cancer']}, 'referencesModule': {'references': [{'pmid': '39961716', 'type': 'DERIVED', 'citation': 'Saad-Boutry M, Carton M, Ezzili C, Savignoni A. Opioid-free versus opioid-based anaesthesia for free-flap reconstruction surgery of the breast: protocol for a phase III, multicentre, randomised controlled study. BMJ Open. 2025 Feb 17;15(2):e070021. doi: 10.1136/bmjopen-2022-070021.'}]}, 'descriptionModule': {'briefSummary': 'This study will compare morphine consumption during the first 48 hours postoperatively between the OFA group and the CA control group.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Patient eligible for free flap reconstruction surgery of the breastunder general anaesthesia.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Women aged 18 or older.\n2. Patients with a French health insurance coverage (having a French social security number).\n3. Patient eligible for free flap reconstruction surgery of the breastunder general anaesthesia.\n4. Patient who has given written consent to participate in accordance with the regulations.\n5. Having a negative blood pregnancy test for patients of childbea ring age.\n\nExclusion Criteria:\n\n1. Allergy or intolerance to any of the drugs (dexmedetomidine, remifentanil, lidocaine, propofol, dexamethasone, kétamine, ketoprofen, nefopam, paracetamol, morphine, ropivacaine, droperidol, ondansetron).\n2. Known history of heart failure, arrhythmias and/or ischemic heart disease and/or severe renal insufficiency.\n3. Pulse below 50bpm during anaesthesia consultation and/or under beta blocker treatment.\n4. Treatment with ACEI/ARB.\n5. Severe asthma.\n6. Symptomatic gastric or duodenal ulcer with or without treatment.\n7. Baseline systolic blood pressure \\< 100 mmHg.\n8. Chronic preoperative pain and/or use of WHO ladder step 2 or 3 analgesics preoperatively.\n9. Patient already included in another therapeutic trial evaluating an experimental molecule.\n10. Persons deprived of liberty or under guardianship.\n11. Patients with suspected difficulties in assessing pain on a scale.\n12. Inability to undergo trial medical monitoring due to geographic, social or psychological reasons.'}, 'identificationModule': {'nctId': 'NCT05439005', 'acronym': 'OFOBA', 'briefTitle': 'Opioid Free Versus Opioid Based Anaesthesia for Free Flap Reconstruction Surgery of the Breast: A Phase III Multicentric Randomized Controlled Study.', 'organization': {'class': 'OTHER', 'fullName': 'Institut Curie'}, 'officialTitle': 'Opioid Free Versus Opioid Based Anaesthesia for Free Flap Reconstruction Surgery of the Breast: A Phase III Multicentric Randomized Controlled Study.', 'orgStudyIdInfo': {'id': 'IC 2021-07'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'OFA group', 'description': 'OFA (Opioid Free Anaesthesia) group:', 'interventionNames': ['Drug: Dexmedetomidine']}, {'type': 'NO_INTERVENTION', 'label': 'CA control group', 'description': 'CA (Conventional Anaesthesia) control group:'}], 'interventions': [{'name': 'Dexmedetomidine', 'type': 'DRUG', 'description': 'Dexmedetomidine+Lidocaine', 'armGroupLabels': ['OFA group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75005', 'city': 'Paris', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Jane Muret, MD', 'role': 'CONTACT', 'email': 'jane.muret@curie.fr'}, {'name': 'jane Muret, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Institut Curie Paris', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '92210', 'city': 'Saint-Cloud', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Mary SAAD, MD', 'role': 'CONTACT', 'email': 'mary.saad@curie.fr'}, {'name': 'Mary SAAD, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Institut Curie Saint-Cloud', 'geoPoint': {'lat': 48.84598, 'lon': 2.20289}}, {'city': 'Villejuif', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Migena DEMIRI, MD', 'role': 'CONTACT', 'email': 'migena.demiri@gustaveroussy.fr'}, {'name': 'Migena DEMIRI, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Gustave Roussy, Cancer Campus, Grand Paris', 'geoPoint': {'lat': 48.7939, 'lon': 2.35992}}], 'centralContacts': [{'name': 'Anne-Claire COYNE, PhD', 'role': 'CONTACT', 'email': 'anne-claire.coyne@curie.fr', 'phone': '0033156245765'}, {'name': 'Mary SAAD, MD', 'role': 'CONTACT', 'email': 'mary.saad@curie.fr', 'phone': '0033147112371'}], 'overallOfficials': [{'name': 'Mary SAAD, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Institut Curie Saint-Cloud'}]}, 'ipdSharingStatementModule': {'timeFrame': 'Data requests can be submitted starting 9 months after article publication and will be made accessible for up to 12 months.', 'ipdSharing': 'YES', 'description': 'Investigators will share de-identified data sets with interested researchers, educators or clinicians. Materials generated under the project will be disseminated in accordance with Institut Curie policies.', 'accessCriteria': 'Access to trial individual participant data can be requested by qualified researchers engaging in independent scientific reserach, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a data sharing agreement (DSA).'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institut Curie', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}