Ignite Creation Date:
2025-12-25 @ 12:39 AM
Ignite Modification Date:
2026-02-17 @ 10:59 PM
Study NCT ID:
NCT00997867
Status:
COMPLETED
Last Update Posted:
2010-10-28
First Post:
2009-10-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Perineural Catheter Insertion Distance for Continuous Peripheral Nerve Blocks
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010149', 'term': 'Pain, Postoperative'}, {'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 350}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-10', 'completionDateStruct': {'date': '2010-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-10-27', 'studyFirstSubmitDate': '2009-10-18', 'studyFirstSubmitQcDate': '2009-10-18', 'lastUpdatePostDateStruct': {'date': '2010-10-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-10-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Average pain in the three hours previous to a phone call the day following surgery as measured on a numeric rating scale (0-10, 0=no pain, 10=worst imaginable pain).', 'timeFrame': 'Day 1 after surgery, 3 hours prior to phone call'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Pain', 'Surgery', 'Catheter', 'Nerve Block', 'Popliteal', 'Sciatic', 'Femoral', 'Interscalene', 'UCSD', 'Moderate-to-severe pain', 'Perineural Catheter', 'Orthopedic Surgery'], 'conditions': ['Lower Extremity Surgery', 'Upper Extremity Surgery', 'Post-operative Pain']}, 'descriptionModule': {'briefSummary': 'This is a research study to determine if the effects of continuous peripheral nerve blocks are influenced by the distance of insertion past the needle tip of the perineural catheter.', 'detailedDescription': 'Specific Aim: Research study to determine the relationships between perineural catheter insertion distance and subsequent continuous peripheral nerve block effects.\n\nHypothesis: during ultrasound-guided perineural catheter placement, inserting the catheter 0-1cm past the needle tip is associated with decreased postoperative pain compared with inserting the catheter 5-6cm past the needle tip.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* undergoing surgery with a planned popliteal perineural catheter for postoperative analgesia\n* age 18 years or older\n\nExclusion Criteria:\n\n* pregnancy\n* inability to communicate with the investigators and hospital staff\n* incarceration\n* clinical neuropathy in the surgical extremity\n* chronic high-dose opioid use\n* history of opioid abuse'}, 'identificationModule': {'nctId': 'NCT00997867', 'briefTitle': 'Perineural Catheter Insertion Distance for Continuous Peripheral Nerve Blocks', 'organization': {'class': 'OTHER', 'fullName': 'University of California, San Diego'}, 'officialTitle': 'Perineural Catheter Insertion Distance for Continuous Peripheral Nerve Blocks', 'orgStudyIdInfo': {'id': 'Catheter Insertion Distance'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Catheter 0-1cm past needle tip', 'description': 'Patients will be receiving a sciatic (popliteal), femoral, or interscalene nerve block and will be randomized to having the catheter placed 0-1cm past the needle tip. The patient will be called the following day by research staff to assess their post-surgical pain.', 'interventionNames': ['Procedure: Sciatic catheter left 0-1cm past needle tip vs. 5-6cm past needle tip']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Catheter placed 5-6cm past needle tip', 'description': 'Patients will be receiving a sciatic (popliteal), femoral, or interscalene nerve block and will be randomized to having the catheter placed 5-6cm past the needle tip. Patients will be called the following day by research staff to assess their post-surgical pain.', 'interventionNames': ['Procedure: Sciatic catheter left 0-1cm past needle tip vs. 5-6cm past needle tip']}], 'interventions': [{'name': 'Sciatic catheter left 0-1cm past needle tip vs. 5-6cm past needle tip', 'type': 'PROCEDURE', 'description': 'Patients undergoing orthopedic surgery who are getting a perineural catheter will be randomized to one of two groups: catheter tip placed 0-1cm past needle tip or catheter tip placed 5-6cm past needle tip. Patients will be called by research staff the day following surgery to assess their post-surgical pain using a numeric rating scale.', 'armGroupLabels': ['Catheter 0-1cm past needle tip', 'Catheter placed 5-6cm past needle tip']}]}, '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'}}}}