Ignite Creation Date:
2025-12-24 @ 7:19 PM
Ignite Modification Date:
2026-02-20 @ 11:12 AM
Study NCT ID:
NCT02406703
Status:
COMPLETED
Last Update Posted:
2020-03-11
First Post:
2015-03-30
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Impact of Chloroprocaine 3% for Ambulatory Foot Surgery on Perioperative Process Costs
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C004616', 'term': 'chloroprocaine'}, {'id': 'D008619', 'term': 'Mepivacaine'}], 'ancestors': [{'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2014-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-03-09', 'studyFirstSubmitDate': '2015-03-30', 'studyFirstSubmitQcDate': '2015-04-01', 'lastUpdatePostDateStruct': {'date': '2020-03-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-04-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cost minimization analysis', 'timeFrame': '6 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['local anesthesia', 'regional anesthetic'], 'conditions': ['Impact of Anesthetic Choice on Costs']}, 'descriptionModule': {'briefSummary': 'Background and Objectives Short acting regional anesthetics have already been successfully employed for peripheral nerve blocks in an ambulatory surgery setting. However, the impact on direct and indirect perioperative costs comparing two different short-acting local anesthetics has not been performed, yet.\n\nMethods In an observational study including 50 patients per group, patient undergoing popliteal block with chloroprocaine 3% or mepivacaine 1.5% for ambulatory minor foot surgery were compared. The primary outcome was the saving of both direct and indirect perioperative costs. Secondary outcomes were block success, onset time and block duration, patient satisfaction and unplanned outpatient visits or readmissions after discharge.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'ASA I-III scheduled for elective, unilateral, ambulant minor foot surgery (percutaneous hallux valgus correction, osteotomies, tenotomies, mallet and hammer toes correction, screws and/or plaques removal)', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ASA I-III scheduled for elective, unilateral, ambulant minor foot surgery (percutaneous hallux valgus correction, osteotomies, tenotomies, mallet and hammer toes correction, screws and/or plaques removal)\n\nExclusion Criteria:\n\n* known allergy to drugs used in the study;\n* coagulopathies, known neuropathy;\n* pregnancy;\n* chronic pain;\n* drug or alcohol abuse;\n* psychiatric disease or lack of competence affecting compliance and evidence of ongoing sepsis or local skin / subcutaneous tissues infections in the popliteal fossa.'}, 'identificationModule': {'nctId': 'NCT02406703', 'briefTitle': 'The Impact of Chloroprocaine 3% for Ambulatory Foot Surgery on Perioperative Process Costs', 'organization': {'class': 'OTHER', 'fullName': 'Ospedale Regionale Bellinzona e Valli'}, 'officialTitle': 'Can the Choice of the Local Anesthetic Have an Impact on Ambulatory Surgery Perioperative Costs? Chloroprocaine for Popliteal Block in Outpatient Foot Surgery', 'orgStudyIdInfo': {'id': 'BLV07'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Chloroprocaine', 'description': 'Patient undergoing popliteal block with chloroprocaine', 'interventionNames': ['Drug: Chloroprocaine']}, {'label': 'Mepivacaine', 'description': 'Patient undergoing popliteal block with mepivacaine', 'interventionNames': ['Drug: Mepivacaine']}], 'interventions': [{'name': 'Chloroprocaine', 'type': 'DRUG', 'armGroupLabels': ['Chloroprocaine']}, {'name': 'Mepivacaine', 'type': 'DRUG', 'armGroupLabels': ['Mepivacaine']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ospedale Regionale Bellinzona e Valli', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Andrea Saporito', 'investigatorAffiliation': 'Ospedale Regionale Bellinzona e Valli'}}}}