Ignite Creation Date:
2025-12-24 @ 4:20 PM
Ignite Modification Date:
2025-12-27 @ 6:42 AM
Study NCT ID:
NCT00877266
Status:
COMPLETED
Last Update Posted:
2009-04-07
First Post:
2009-04-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ultrasound Guidance Versus Electrical Stimulation for Perineural Catheter Insertion
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004558', 'term': 'Electric Stimulation'}], 'ancestors': [{'id': 'D010812', 'term': 'Physical Stimulation'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 180}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-04', 'completionDateStruct': {'date': '2009-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-04-06', 'studyFirstSubmitDate': '2009-04-03', 'studyFirstSubmitQcDate': '2009-04-06', 'lastUpdatePostDateStruct': {'date': '2009-04-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-04-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The primary outcome measurement will be the time of placement for a perineural catheter using either ultrasound-guided method or electrical stimulation method.', 'timeFrame': '30 minutes'}], 'secondaryOutcomes': [{'measure': 'Pain and discomfort as assessed by a 0-10 scale (0=no pain/discomfort and 10=worst pain/discomfort imaginable) by the research coordinator.', 'timeFrame': 'After catheter placement and Postoperative day 1'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['catheter', 'ultrasound guidance', 'nerve stimulation', 'electrical stimulation', 'nerve block', 'UCSD', 'timed placement', 'surgery', 'Catheter Placement Time'], 'conditions': ['Postoperative Pain']}, 'descriptionModule': {'briefSummary': 'This research study is to determine the relative times for perineural catheter placement with the use of ultrasound versus electrical stimulation. The perineural catheter is placed next to the nerves through which local anesthetic is placed to provide pain control following surgery. This study may determine if one method is associated with increased success rate and patient comfort.', 'detailedDescription': 'Primary Specific Aim: To determine if the relative times for perineural catheter placement with the use of ultrasound versus electrical stimulation.\n\nHypothesis: Compared with the use of electrical stimulation, the use of ultrasound guidance when inserting a perineural catheter is associated with a decreased time of placement.\n\nSecondary Specific Aim: To determine if other possible benefits of perineural catheter placement associated with the use of ultrasound guidance versus electrical stimulation.\n\nHypothesis: Compared with the use of electrical stimulation, the use of ultrasound guidance when inserting a perineural catheter is associated with an increased surgical block success rate and catheter-placement success rate, as well as decreased patient discomfort and incidence of venous puncture.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* undergoing surgery with a planned perineural catheter for postoperative analgesia\n* catheter in the interscalene, infraclavicular, popliteal, or femoral anatomic location\n* age 18 years or older\n\nExclusion Criteria:\n\n* pregnancy\n* inability to communicate with the investigators and hospital staff\n* incarceration'}, 'identificationModule': {'nctId': 'NCT00877266', 'briefTitle': 'Ultrasound Guidance Versus Electrical Stimulation for Perineural Catheter Insertion', 'organization': {'class': 'OTHER', 'fullName': 'University of California, San Diego'}, 'officialTitle': 'Ultrasound Guidance vs. Electrical Stimulation for Perineural Catheter Insertion: A Randomized, Controlled Trial', 'orgStudyIdInfo': {'id': 'US vs. NS Perineural Catheter'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1. Ultrasound', 'description': 'Ultrasound is randomly chosen by use of a computer program. The time for catheter placement will begin with the ultrasound probe touches the patient. Patients will be asked their discomfort on a 0-10 scale (0=no discomfort and 10=worst discomfort imaginable) and will be called the next day by the research staff.', 'interventionNames': ['Procedure: perineural mepivicaine catheter placed via ultrasound or electrical stimulation']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2. Electrical Stimulation', 'description': 'Nerve Stimulation (electrical stimulation) is randomly chosen using a computer program. Time of placement begins when the catheter-placement first touches the patient. After catheter placement patient is asked their discomfort on a 0-10 scale (0=no discomfort and 10=worst discomfort imaginable) and called the day after surgery by the research staff.', 'interventionNames': ['Procedure: perineural mepivicaine catheter placed via ultrasound or electrical stimulation']}], 'interventions': [{'name': 'perineural mepivicaine catheter placed via ultrasound or electrical stimulation', 'type': 'PROCEDURE', 'description': 'Patients will be randomized to one of two groups: catheter placement via ultrasound or nerve stimulation. Placement of the catheter will be timed by research staff and discomfort level asked after placement of catheter. If the catheter is not placed by the randomized method within 15 minutes, the practitioner my switch to the alternate method. Patients will be called the morning after surgery by research staff to assess discomfort levels.', 'armGroupLabels': ['1. Ultrasound', '2. Electrical Stimulation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92103', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'UCSD Medical Center', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}], 'overallOfficials': [{'name': 'Brian M Ilfeld, M.D., M.S.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, San Diego'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, San Diego', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Brian Ilfeld, M.D., M.S./ Principal Investigator', 'oldOrganization': 'University of California, San Diego, Department of Anesthesiology'}}}}