Ignite Creation Date:
2025-12-24 @ 6:37 PM
Ignite Modification Date:
2026-01-05 @ 5:44 AM
Study NCT ID:
NCT02670057
Status:
COMPLETED
Last Update Posted:
2017-12-14
First Post:
2016-01-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sphenopalatine Ganglion Block to Treat Shoulder Pain During and/or After Cesarean
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 117}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-12', 'completionDateStruct': {'date': '2017-12-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-12-12', 'studyFirstSubmitDate': '2016-01-21', 'studyFirstSubmitQcDate': '2016-01-27', 'lastUpdatePostDateStruct': {'date': '2017-12-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-02-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-12-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Reduction of shoulder pain measured using Verbal Analog pain Scale (VAS)', 'timeFrame': '90 Minutes'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Ipsilateral Shoulder Pain']}, 'descriptionModule': {'briefSummary': 'The purpose of this open label pilot study is to evaluate the utility of sphenopalatine ganglion (SPG) block to manage ipsilateral shoulder pain (ISP) during and/or after cesarean.', 'detailedDescription': 'Shoulder pain thought to be caused by blood and amniotic fluid irritation of the diaphragm and nerves that supply the shoulder, can occur during and/or after a cesarean. Investigators will consent 100 patients, and will enroll 10 patients who develop ISP and have a score of is \\>5/10 on the Verbal Analog pain Scale (VAS). Patients will be their own controls. Transnasal SPG block will be performed after childbirth, and and beginning at 20 minutes post treatment, the patient will be asked to rate their shoulder pain using the VAS a number of times.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Cesarean\n* Presence of post-operative ISP, VAS \\>5/10\n* American Society of Anesthesiologists Class 1 - 3.\n* No allergy to lidocaine\n\nExclusion Criteria:\n\n* American Society of Anesthesiologists Class 4 or 5.\n* Allergy to lidocaine\n* Nasal pathology (e.g., deviated septum)\n* Patients who receive sedatives during cesarean\n* Bleeding diathesis\n* Any patient who the PI feels will be unable to comply with all protocol related procedures\n* Shoulder pain prior to cesarean'}, 'identificationModule': {'nctId': 'NCT02670057', 'briefTitle': 'Sphenopalatine Ganglion Block to Treat Shoulder Pain During and/or After Cesarean', 'organization': {'class': 'OTHER', 'fullName': 'NYU Langone Health'}, 'officialTitle': 'Sphenopalatine Ganglion Block to Treat Shoulder Pain During and/or After Cesarean', 'orgStudyIdInfo': {'id': '15-00619'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Transnasal SPG block', 'interventionNames': ['Procedure: Transnasal SPG block']}], 'interventions': [{'name': 'Transnasal SPG block', 'type': 'PROCEDURE', 'armGroupLabels': ['Transnasal SPG block']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10016', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'New York University School of Medicine', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Gilbert Grant', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'New York University Medical School'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'NYU Langone Health', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}