Ignite Creation Date:
2025-12-25 @ 12:31 AM
Ignite Modification Date:
2026-02-28 @ 9:32 AM
Study NCT ID:
NCT01473667
Status:
TERMINATED
Last Update Posted:
2019-02-01
First Post:
2011-11-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Superficial Cervical Plexus Block for Pacemaker Insertion
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D054832', 'term': 'Urocortins'}, {'id': 'D003766', 'term': 'Dental Occlusion'}], 'ancestors': [{'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D009479', 'term': 'Neuropeptides'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D003813', 'term': 'Dentistry'}, {'id': 'D009063', 'term': 'Dental Physiological Phenomena'}, {'id': 'D055688', 'term': 'Digestive System and Oral Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'whyStopped': 'change in practice occured', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2011-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2016-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-01-31', 'studyFirstSubmitDate': '2011-11-14', 'studyFirstSubmitQcDate': '2011-11-16', 'lastUpdatePostDateStruct': {'date': '2019-02-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-11-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To decrease opioid requirements after Pacemaker insertion', 'timeFrame': 'first 24 hrs post pacemaker insertion'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Pacemaker Insertion', 'Regional Block', 'Pain']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate clinical outcomes from two current standard of care pain control procedures performed for patients undergoing pacemaker insertion.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18-100 years old\n* Registered patients at Mayo Clinic in Florida scheduled to undergo primary insertion of pacemaker\n\nExclusion Criteria:\n\n* Emergency placement of pacemaker\n* Sub-pectoral placement of pacemaker\n* Patients with history of chronic pain\n* Patients with anatomical abnormality or disruption to the pacemaker insertion site or site of block placement\n* Patients with allergy to local anesthetic'}, 'identificationModule': {'nctId': 'NCT01473667', 'briefTitle': 'Superficial Cervical Plexus Block for Pacemaker Insertion', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'Superficial Cervical Plexus Block for Pacemaker Insertion', 'orgStudyIdInfo': {'id': '11-005969'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Superficial Cervical Plexus Block', 'interventionNames': ['Procedure: Superficial Cervical Plexus Block (SCP) block']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Local Infiltration', 'interventionNames': ['Procedure: Local site infiltration']}], 'interventions': [{'name': 'Superficial Cervical Plexus Block (SCP) block', 'type': 'PROCEDURE', 'description': 'SCP block using 10-15ml of 1% Ropivacaine', 'armGroupLabels': ['Superficial Cervical Plexus Block']}, {'name': 'Local site infiltration', 'type': 'PROCEDURE', 'description': 'Local site infiltration using 2% lidocaine', 'armGroupLabels': ['Local Infiltration']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32224', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'Mayo Clinic', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}], 'overallOfficials': [{'name': 'Christopher Robards, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Christopher B. Robards', 'investigatorAffiliation': 'Mayo Clinic'}}}}