Ignite Creation Date:
2025-12-24 @ 11:54 PM
Ignite Modification Date:
2025-12-25 @ 9:50 PM
Study NCT ID:
NCT04341051
Status:
UNKNOWN
Last Update Posted:
2020-04-10
First Post:
2020-04-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Sciatic Block Increases Regional Saturation in Peripheral Artery Occlusive Disease.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'C564658', 'term': 'Peripheral Arterial Occlusive Disease 1'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 31}, 'targetDuration': '1 Day', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2020-04-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-04', 'completionDateStruct': {'date': '2020-05-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-04-08', 'studyFirstSubmitDate': '2020-04-08', 'studyFirstSubmitQcDate': '2020-04-08', 'lastUpdatePostDateStruct': {'date': '2020-04-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-04-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-05-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Regional Oxigen saturation downstream of popliteal region', 'timeFrame': '1 day', 'description': 'NIRS misuration of delivered oxigen T0)before the execution of sciatic popliteal block T1) after 5 minuts, T2)15 minuts, T3)30 minuts, T4)after the revascularization'}], 'secondaryOutcomes': [{'measure': 'Comparing the results between AOCP IIa to III (Fontaine Classification)', 'timeFrame': '1 day', 'description': 'NIRS misuration of delivered oxigen T0)before the execution of sciatic popliteal block T1) after 5 minuts, T2)15 minuts, T3)30 minuts, T4)after the revascularization'}, {'measure': 'Comparing the results between patients with occlusion of a single arthery and patients with more occluded arthery', 'timeFrame': '1 day', 'description': 'NIRS misuration of delivered oxigen T0)before the execution of sciatic popliteal block T1) after 5 minuts, T2)15 minuts, T3)30 minuts, T4)after the revascularization'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['regional oxigen saturation'], 'conditions': ['Peripheral Artery Occlusive Disease', 'Popliteal Sciatic Nerve Block']}, 'descriptionModule': {'briefSummary': 'We conducted Single-center prospective observational study to evaluate the improvement of peripheral vascular perfusion monitored with near-infrared spectroscopy, in patients undergoing endovascular surgery after performing sciatic nervous block.', 'detailedDescription': 'The aims of that study is to check regional oxigen saturation variability in patients suffering from Peripheral Artery Occlusive Disease (IIa to III Fontaine classification) undergoing popliteal sciatic nerve block as analgesic procedure before vascular surgery. We want to evaluate the increase in regional microcirculation after the popliteal nerve blocks due to vasoplegic response and vasodilatation after performing regional anaesthesia. We will place NIRS electrode on the instep of the foot to evaluate regional oxigen saturation in the interested leg before the performing of popliteal sciatic nerve block and then during the surgery (after 5 minuts, 15 minuts, 30 minuts), and after the end of the procedure.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients suffering from Peripheral Artery Occlusive Disease undergoing popliteal sciatic nerve block as analgesic procedure before revascularization surgery', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age: \\> 18 years\n* Peripheral artery occlusive desease involving popliteal, tibial and/or peroneal artery\n* Stadiation IIa to III in Fontaine classification\n* Eligibility for PTA or Stenting\n\nExclusion Criteria:\n\n* trophic alteration of the application site of the NIRS\n* less than 18 years\n* Pregnancy\n* need of sedation during the procedure\n* revascularization performed as emergency surgery\n* Allergic reactions with local anaesthetic\n* Previous surgery involving the interested artery'}, 'identificationModule': {'nctId': 'NCT04341051', 'briefTitle': 'Sciatic Block Increases Regional Saturation in Peripheral Artery Occlusive Disease.', 'organization': {'class': 'OTHER', 'fullName': 'A.O.U. Città della Salute e della Scienza'}, 'officialTitle': 'Sciatic Block Increases Regional Saturation in Peripheral Artery Occlusive Disease Monitored by NIRS: a Prospective Monocentric Study.', 'orgStudyIdInfo': {'id': '0033871'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Case', 'description': 'we will observe the regional saturation of O2 through NIRS at the following time: T0(before peripheral anesthesia); T1 (5 minutes from the block); T2 (15 minutes from the block); T3 (30 minutes from the block); T4 (after revascularization); At each interval PA, SpO2 and NIRS were also recorded in the contralateral limb as control data.', 'interventionNames': ['Other: Case']}], 'interventions': [{'name': 'Case', 'type': 'OTHER', 'description': 'Mesure with NIRS regional saturation in patients undergoing popliteal block during vascular surgery for chronic obliterating arteriopathy (IIa to III Fontaine Classification)', 'armGroupLabels': ['Case']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Fabio Gobbi, Doctor', 'role': 'CONTACT', 'email': 'fabiogobbi74@gmail.com', 'phone': '+39 3476655128'}], 'overallOfficials': [{'name': 'Fabio Gobbi, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'A.O.U. Città della Salute e della Scienza'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'A.O.U. Città della Salute e della Scienza', 'class': 'OTHER'}, 'collaborators': [{'name': "San Salvatore Hospital of L'Aquila", 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Doctor', 'investigatorFullName': 'Fabio Gobbi', 'investigatorAffiliation': 'A.O.U. Città della Salute e della Scienza'}}}}