Ignite Creation Date:
2025-12-25 @ 1:33 AM
Ignite Modification Date:
2025-12-27 @ 10:08 PM
Study NCT ID:
NCT04928794
Status:
COMPLETED
Last Update Posted:
2024-10-21
First Post:
2021-05-26
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Thermal-Imaging Comparison of Nerve Blocks for Bilateral Mastectomy
Sponsor:
Organization:
Raw JSON
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'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Average Skin Temperature', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Erector Spinae Plane Block Side', 'description': 'Side of body with Erector Spinae Plane Block'}, {'id': 'OG001', 'title': 'Paravertebral Block Side', 'description': 'Side of body with Paravertebral Block'}], 'classes': [{'categories': [{'measurements': [{'value': '33.3', 'spread': '0.9', 'groupId': 'OG000'}, {'value': '33.7', 'spread': '0.9', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '30 minutes', 'description': 'Thermography-measured temperature of skin affected by nerve block', 'unitOfMeasure': 'degrees C', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Erector Spinae Plane Block', 'description': 'Regional anesthesia with injected 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'groupId': 'BG002'}]}], 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_UNITS', 'unitOfMeasure': 'Anatomical sides [Right vs Left]', 'denomUnitsSelected': 'Anatomical sides [Right vs Left]'}, {'title': 'Sex: Female, Male', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}, {'units': 'Anatomical sides [Right vs Left]', 'counts': [{'value': '8', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '16', 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{'units': 'Anatomical sides [Right vs Left]', 'counts': [{'value': '8', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}], 'classes': [{'categories': [{'measurements': [{'value': '88.6', 'spread': '1.7', 'groupId': 'BG000'}, {'value': '88.6', 'spread': '1.7', 'groupId': 'BG001'}, {'value': '88.6', 'spread': '1.7', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'degrees F', 'dispersionType': 'STANDARD_DEVIATION', 'denomUnitsSelected': 'Participants'}], 'typeUnitsAnalyzed': 'Anatomical sides [Right vs Left]'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-03-17', 'size': 1366863, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-12-19T15:17', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 8}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-05-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2021-08-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-10-17', 'studyFirstSubmitDate': '2021-05-26', 'resultsFirstSubmitDate': '2023-12-19', 'studyFirstSubmitQcDate': '2021-06-15', 'lastUpdatePostDateStruct': {'date': '2024-10-21', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-10-17', 'studyFirstPostDateStruct': {'date': '2021-06-16', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-10-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-08-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Skin Temperature Increase From Baseline', 'timeFrame': '30 minutes', 'description': 'Thermography-measured increase in temperature of skin affected by nerve block'}], 'secondaryOutcomes': [{'measure': 'Average Skin Temperature', 'timeFrame': '30 minutes', 'description': 'Thermography-measured temperature of skin affected by nerve block'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Paravertebral nerve block', 'Erector Spinae Plane block'], 'conditions': ['Anesthesia, Conduction']}, 'descriptionModule': {'briefSummary': 'This is a one-armed trial of two regional anesthesia (peripheral nerve block) techniques to provide postoperative analgesia after bilateral mastectomy. The two techniques are paravertebral block and erector spinae plane (ESP) block. Patients will serve as their own controls, with one block technique applied on one side of the body and the other technique contralaterally. Anatomical distribution of block effectiveness will be assessed with thermal imaging, and this distribution will be visually compared between the two techniques.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult female patients having bilateral mastectomy surgery at University of New Mexico Outpatient Surgical and Imaging Services (OSIS) facility\n* Age \\>18 years\n* Consenting to regional anesthesia for postoperative pain control\n\nExclusion Criteria:\n\n* Age \\<18 years\n* Unable to consent\n* Using anticoagulant medication or have a bleeding disorder\n* Pregnancy\n* Inability to speak English for consent process'}, 'identificationModule': {'nctId': 'NCT04928794', 'briefTitle': 'Thermal-Imaging Comparison of Nerve Blocks for Bilateral Mastectomy', 'organization': {'class': 'OTHER', 'fullName': 'University of New Mexico'}, 'officialTitle': 'Dermatomal Spread of Paravertebral and Erector Spinae Plane Nerve Blocks as Compared by Thermal Imaging', 'orgStudyIdInfo': {'id': '21-104 Billstrand'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Peripheral Nerve Block with 2 Techniques', 'interventionNames': ['Procedure: Erector Spinae Plane Block', 'Procedure: Paravertebral Block']}], 'interventions': [{'name': 'Erector Spinae Plane Block', 'type': 'PROCEDURE', 'description': 'Regional anesthesia with injected local anesthetic solution, placed in space underlying erector spinae muscles', 'armGroupLabels': ['Peripheral Nerve Block with 2 Techniques']}, {'name': 'Paravertebral Block', 'type': 'PROCEDURE', 'description': 'Regional anesthesia with injected local anesthetic solution, placed in space adjacent to vertebrae', 'armGroupLabels': ['Peripheral Nerve Block with 2 Techniques']}]}, 'contactsLocationsModule': {'locations': [{'zip': '87102', 'city': 'Albuquerque', 'state': 'New Mexico', 'country': 'United States', 'facility': 'University of New Mexico Outpatient Surgical and Imaging Services', 'geoPoint': {'lat': 35.08449, 'lon': -106.65114}}], 'overallOfficials': [{'name': 'Mary Billstrand, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of New Mexico'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of New Mexico', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Mary Billstrand', 'investigatorAffiliation': 'University of New Mexico'}}}}