Ignite Creation Date:
2025-12-25 @ 2:06 AM
Ignite Modification Date:
2026-03-02 @ 4:23 PM
Study NCT ID:
NCT01376960
Status:
COMPLETED
Last Update Posted:
2016-08-22
First Post:
2009-07-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ankle Block Versus Popliteal Fossa Block as Primary Anesthesia for Forefoot Surgical Procedures
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 202}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-08', 'completionDateStruct': {'date': '2016-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-08-19', 'studyFirstSubmitDate': '2009-07-29', 'studyFirstSubmitQcDate': '2011-06-17', 'lastUpdatePostDateStruct': {'date': '2016-08-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-06-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Conversion to general anesthesia following either a single shot popliteal fossa block or ankle block', 'timeFrame': 'Participants will be followed for the duration of the surgery, an expected average of 2 hours', 'description': 'Popliteal fossa and ankle blocks are types of anesthesia used during surgery. If these methods are not effective as an anesthetic during surgery the anethesiologist will convert to general anesthesia.'}], 'secondaryOutcomes': [{'measure': 'Visual Analog Pain Scale (VAS)', 'timeFrame': '24 hours postoperatively'}, {'measure': 'Patient Satisfaction', 'timeFrame': '48 hours postoperative'}, {'measure': 'Length of Post Anesthesia Care Unit (PACU) stay', 'timeFrame': 'Up to 6 hours postoperative', 'description': 'Length of PACU stay is calculated from the time the patient is taken from the operative suite to PACU, ie recovery, to the time the patient leaves PACU.'}, {'measure': 'Narcotic Use', 'timeFrame': 'Up to 30 days postoperative'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['forefoot surgery', 'Ankle Block', 'Popliteal Fossa Block'], 'conditions': ['Anesthesia', 'Forefoot Surgery']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare, for the first time ever, single shot popliteal fossa blocks to ankle blocks as primary anesthesia for patients undergoing forefoot procedures. The primary outcome variable for this study is the percentage of patients that convert to general anesthesia following either a single shot popliteal fossa block or ankle block.\n\nH0: There is no difference in the percentage of patients that convert to general anesthesia between single shot popliteal fossa blocks and ankle blocks.\n\nHA: There will be a lower percentage of patients receiving a single shot popliteal fossa block that convert to general anesthesia compared to patients receiving an ankle block.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients undergoing elective forefoot surgery, including both soft-tissue and osseous procedures\n\nExclusion Criteria:\n\n* Diabetes\n* Any form of Peripheral neuropathy\n* Known allergy to local anesthesia\n* Active infection'}, 'identificationModule': {'nctId': 'NCT01376960', 'briefTitle': 'Ankle Block Versus Popliteal Fossa Block as Primary Anesthesia for Forefoot Surgical Procedures', 'organization': {'class': 'OTHER', 'fullName': 'OrthoCarolina Research Institute, Inc.'}, 'officialTitle': 'Ankle Block Versus Popliteal Fossa Block as Primary Anesthesia for Forefoot Surgical Procedures: A Prospective Comparison', 'orgStudyIdInfo': {'id': '121809A'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'single shot popliteal fossa block', 'interventionNames': ['Procedure: elective forefoot surgery']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'ankle blocks', 'interventionNames': ['Procedure: elective forefoot surgery']}], 'interventions': [{'name': 'elective forefoot surgery', 'type': 'PROCEDURE', 'description': 'Includes both soft-tissue and osseous procedures.', 'armGroupLabels': ['ankle blocks', 'single shot popliteal fossa block']}]}, 'contactsLocationsModule': {'locations': [{'zip': '28203', 'city': 'Charlotte', 'state': 'North Carolina', 'country': 'United States', 'facility': 'OrthoCarolina, PA', 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}], 'overallOfficials': [{'name': 'Bruce E Cohen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'OrthoCarolina, PA'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'OrthoCarolina Research Institute, Inc.', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}