Ignite Creation Date:
2025-12-24 @ 7:58 PM
Ignite Modification Date:
2025-12-29 @ 1:58 PM
Study NCT ID:
NCT01231204
Status:
COMPLETED
Last Update Posted:
2016-04-11
First Post:
2010-10-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prevention of Post-Mastectomy Breast Pain Using Ambulatory Continuous Paravertebral Blocks
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D059373', 'term': 'Mastodynia'}, {'id': 'D010149', 'term': 'Pain, Postoperative'}], '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'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077330', 'term': 'Saline Solution'}], 'ancestors': [{'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-04', 'completionDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-04-07', 'studyFirstSubmitDate': '2010-10-27', 'studyFirstSubmitQcDate': '2010-10-29', 'lastUpdatePostDateStruct': {'date': '2016-04-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-11-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain Scores (NRS)', 'timeFrame': 'Day following Surgery', 'description': 'Pain score on the 0-10 Numeric Rating Scale given as part of the Brief Pain Inventory'}], 'secondaryOutcomes': [{'measure': 'Pain scores', 'timeFrame': 'First 4 postoperative days', 'description': 'Measured on the NRS (defined above) during the first 4 postoperative days'}, {'measure': 'Opioid Requirements', 'timeFrame': 'First 4 postoperative days', 'description': 'Both in and out of the hospital during the first 3 postoperative days'}, {'measure': 'Opioid-related side effects', 'timeFrame': 'First 4 postoperative days', 'description': 'Both in and out of the hospital during the first 4 postoperative days'}, {'measure': 'Sleep Disturbances', 'timeFrame': 'First 4 postoperative days', 'description': 'Due to breast pain during the first 4 postoperative days'}, {'measure': 'Cancer Recurrence', 'timeFrame': 'One Year following Surgery', 'description': "Patients' records will be investigated for indications of cancer recurrence up to 3 years following catheter placement (including estrogen receptor status as + or -). Patients may be contacted by phone if records suggest that the patient has not returned to the original surgeon within the previous 12 months"}, {'measure': 'Pain and Physical Functioning', 'timeFrame': 'Within first year of surgery', 'description': 'Brief Pain Inventory given by phone on postop day 1, 4, 8; and weeks 4, 12; and months 3 and 12'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Breast Cancer', 'Mastectomy', 'UCSD', 'Surgery', 'PVB Catheter', 'Paravertebral Catheter', 'Breast Pain', 'Mastectomy Pain', 'Postoperative Pain'], 'conditions': ['Paravertebral Catheter Insertion', 'Mastectomy', 'Breast Cancer']}, 'descriptionModule': {'briefSummary': 'Research study to determine if putting local anesthetic-or numbing medication-through a tiny tube placed next to the nerves that go to a breast prior to and following a mastectomy will decrease subsequent pain.', 'detailedDescription': 'Specific Aim 1: To determine if, compared with current and customary analgesia, the addition of a multiple-day ambulatory continuous paravertebral block decreases the incidence and severity of post-mastectomy pain.\n\nHypothesis 1: Following mastectomy, the incidence and severity of breast pain will be significantly decreased in the week following surgery with a multiple-day ambulatory continuous paravertebral block as compared with patients receiving standard-of-care treatment (as measured on the 11-point numeric rating scale).\n\nHypothesis 2: Following mastectomy, the incidence and severity of chronic pain will be significantly decreased three months following multiple-day ambulatory continuous paravertebral blocks as compared with patients receiving standard-of-care treatment (as measured on the 11-point numeric rating scale).'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* undergoing unilateral or bilateral mastectomy\n* desiring analgesia with a paravertebral nerve block(s)\n* age 18 years or older\n* female\n\nExclusion Criteria:\n\n* morbid obesity as defined by a body mass index \\> 40\n* renal insufficiency\n* chronic opioid use\n* history of opioid abuse\n* any comorbidity which results in moderate or severe functional limitation\n* inability to communicate with the investigators or hospital staff\n* pregnancy\n* incarceration'}, 'identificationModule': {'nctId': 'NCT01231204', 'briefTitle': 'Prevention of Post-Mastectomy Breast Pain Using Ambulatory Continuous Paravertebral Blocks', 'organization': {'class': 'OTHER', 'fullName': 'University of California, San Diego'}, 'officialTitle': 'Prevention of Post-Mastectomy Breast Pain Using Ambulatory Continuous Paravertebral Blocks', 'orgStudyIdInfo': {'id': 'PVB Catheter Study'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo Infusion', 'description': 'Patients will be randomized to receive a continuous infusion of Normal Saline via a Paravertebral Nerve Block.', 'interventionNames': ['Procedure: Placebo (normal saline) Continuous Infusion']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Ropivicaine 0.4% Infusion', 'description': 'Patients will be randomized to receive a continuous infusion of 0.4% Ropivicaine via a Paravertebral Nerve Block.', 'interventionNames': ['Procedure: Ropivicaine 0.4% Continuous Infusion']}], 'interventions': [{'name': 'Placebo (normal saline) Continuous Infusion', 'type': 'PROCEDURE', 'description': 'Patients randomized to this group will receive an initial catheter placement using the standard Ultrasound-guided Technique. For the surgical procedure they will receive 15cc of 0.5%Ropivicaine. Following the surgical procedure they will receive a pain pump filled with normal saline. The normal saline infusion will continue for the 3 days following surgery. All patients will have access to other pain relievers for break-through pain. All patients will have the outcome measures assessed.', 'armGroupLabels': ['Placebo Infusion']}, {'name': 'Ropivicaine 0.4% Continuous Infusion', 'type': 'PROCEDURE', 'description': 'Patients randomized to this group will receive an initial catheter placement using the standard Ultrasound-guided Technique. For the surgical procedure they will receive 15cc of 0.5%Ropivicaine. Following the surgical procedure they will receive a pain pump filled with 0.4%Ropivicaine. The 0.4%Ropivicaine infusion will continue for the 3 days following surgery. All patients will have access to other pain relievers for break-through pain. All patients will have the outcome measures assessed.', 'armGroupLabels': ['Ropivicaine 0.4% Infusion']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92093', 'city': 'La Jolla', 'state': 'California', 'country': 'United States', 'facility': 'UCSD Thornton Hospital', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}], 'overallOfficials': [{'name': 'Brian M Ilfeld, M.D., M.S.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, San Diego, Department of Anesthesia'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, San Diego', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor, In Residence', 'investigatorFullName': 'Brian M. Ilfeld, MD, MS', 'investigatorAffiliation': 'University of California, San Diego'}}}}