Ignite Creation Date:
2025-12-24 @ 6:50 PM
Ignite Modification Date:
2026-01-01 @ 6:43 PM
Study NCT ID:
NCT06276257
Status:
RECRUITING
Last Update Posted:
2025-03-07
First Post:
2024-02-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Paravertebral Block for Mastectomy with Immediate Reconstruction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010149', 'term': 'Pain, Postoperative'}], 'ancestors': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-08-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-05', 'studyFirstSubmitDate': '2024-02-14', 'studyFirstSubmitQcDate': '2024-02-21', 'lastUpdatePostDateStruct': {'date': '2025-03-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluation of postoperative pain using the BPI', 'timeFrame': '24 hours, 28 hours, 72 hours after surgery', 'description': 'Postoperative pain will be measured using the Brief Pain Inventory (BPI)'}], 'secondaryOutcomes': [{'measure': 'Total use of opioids received intraoperatively.', 'timeFrame': 'within 3 months after surgery', 'description': 'Total dose of narcotics received intraoperatively (in mg morphine equivalent)'}, {'measure': 'Use of non-opioid analgesia intraoperatively', 'timeFrame': 'During surgery', 'description': 'Analgesics other than opioids used intraoperatively'}, {'measure': 'Total dose of opioids received in the PACU', 'timeFrame': 'During PACU stay', 'description': 'Total dose of narcotics received in the post-anesthesia care unit (PACU) (in mg morphine equivalent)'}, {'measure': 'Time before first opioid', 'timeFrame': 'Within 3 months after surgery', 'description': 'Time to first opioid dose after surgery'}, {'measure': 'Total opioids consumed in the 48 hours following surgery', 'timeFrame': 'Within 48 hours after surgery', 'description': 'Total quantity of opioids consumed in the 48 hours following surgery (in morphine equivalent)'}, {'measure': 'Chronic pain', 'timeFrame': 'At 3 months after surgery', 'description': 'Presence of chronic pain at the surgical site at 3 months'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Postoperative Pain']}, 'descriptionModule': {'briefSummary': 'Following a mastectomy, patients may develop chronic pain, called post-mastectomy pain syndrome (PMPS). This syndrome manifests itself as complex neuropathic pain that seems linked to nerve damage suffered either during surgery, during healing or by nervous system dysfunction. However, the exact pathophysiology remains unknown. Typically, the pain is located on the ipsilateral side of the surgery and projects to the anterior thorax to the lateral thorax and may affect the proximal part of the arm. This pain persists for more than three months following the procedure and has the characteristics of neuropathic pain: burning sensation, tingling, electric shock, hyperalgesia, etc. The prevalence of PMDS varies between 2% and 78%; this disparity comes from the fact that there are no clear criteria in the literature for making the diagnosis. One of the risk factors for developing PMDS is the presence of acute pain immediately postoperatively.\n\nThe main objective of this study is to compare two analgesic modalities, namely BPV (study modality) and usual analgesia (control modality), in patients undergoing total mastectomy with immediate reconstruction under general anesthesia with the aim of to evaluate their functional pain score at 24, 48 and 72 hours following the surgical procedure.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18-70 years of age\n* woman scheduled for unilateral mastectomy with immediate reconstruction\n\nExclusion Criteria:\n\n* Patients who will have an axillary dissection during surgery.\n* Woman with severe hepatic insufficiency (Child Pugh Classification B and above24).\n* Woman with kidney failure stage 4 and above25.\n* Body mass index (BMI) \\> 40 kg/m2.\n* Woman with an allergy to local anesthetics.\n* Woman with a bleeding disorder in whom BPV is contraindicated.\n* Woman in whom stopping antiplatelet or anticoagulant therapy does not allow compliance with the standards of practice of neuraxial anesthesia issued by the American Society of Regional Anesthesia.\n* Woman with a single lung.\n* Pregnant woman.'}, 'identificationModule': {'nctId': 'NCT06276257', 'briefTitle': 'Paravertebral Block for Mastectomy with Immediate Reconstruction', 'organization': {'class': 'OTHER', 'fullName': 'CHU de Quebec-Universite Laval'}, 'officialTitle': 'Comparison Between Paravertebral Block and Usual Analgesia in Patients Undergoing Unilateral Total Mastectomy with Immediate Reconstruction', 'orgStudyIdInfo': {'id': '2024-7301'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Paravertebral block', 'description': 'Preoperative paravertebral block on the side of mastectomy in addition to usual analgesia.', 'interventionNames': ['Procedure: Paravertebral block']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Usual analgesia', 'description': "Usual analgesia, as per anesthesiologist's preferences.", 'interventionNames': ['Procedure: Usual analgesia']}], 'interventions': [{'name': 'Paravertebral block', 'type': 'PROCEDURE', 'description': 'An ultrasound-guided technique will be used to inject a volume of 40 mL of ropivacaine 0.2%, up to a maximum of 1.5 mg/kg, into the paravertebral space between the T3 and T4 vertebrae.', 'armGroupLabels': ['Paravertebral block']}, {'name': 'Usual analgesia', 'type': 'PROCEDURE', 'description': "The patient will receive analgesia as per the anesthesiologist's preferences.", 'armGroupLabels': ['Usual analgesia']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'G1H5B8', 'city': 'Québec', 'state': 'Quebec', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Martin Beaumont', 'role': 'CONTACT', 'email': 'Martin.Beaumont@chudequebec.ca', 'phone': '418-525-4444'}], 'facility': 'CHU de Quebec - Universite Laval', 'geoPoint': {'lat': 46.81228, 'lon': -71.21454}}], 'centralContacts': [{'name': 'Jean-Charles Hogue', 'role': 'CONTACT', 'email': 'jean-charles.hogue@crchudequebec.ulaval.ca', 'phone': '418-525-4444'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'CHU de Quebec-Universite Laval', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}