Ignite Creation Date:
2025-12-25 @ 3:38 AM
Ignite Modification Date:
2026-04-06 @ 3:09 PM
Study NCT ID:
NCT06702202
Status:
COMPLETED
Last Update Posted:
2024-11-22
First Post:
2024-11-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Subarachnoid Block and Femoropopliteal Block to Limb Perfusion in PAD Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D058729', 'term': 'Peripheral Arterial Disease'}], 'ancestors': [{'id': 'D050197', 'term': 'Atherosclerosis'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D016491', 'term': 'Peripheral Vascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077442', 'term': 'Lidocaine, Prilocaine Drug Combination'}], 'ancestors': [{'id': 'D008012', 'term': 'Lidocaine'}, {'id': 'D000083', 'term': 'Acetanilides'}, {'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011318', 'term': 'Prilocaine'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D004338', 'term': 'Drug Combinations'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'Single Blind'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2024-07-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-11-20', 'studyFirstSubmitDate': '2024-11-14', 'studyFirstSubmitQcDate': '2024-11-20', 'lastUpdatePostDateStruct': {'date': '2024-11-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-11-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-07-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Measurement of Tissue Oxygen Saturation (StO2)', 'timeFrame': 'TI (Baseline): 10 minutes before the intervention; T2: 5 minutes after the intervention; T3: 15 minutes after the intervention; T4: 30 minutes after the intervention', 'description': 'The primary outcome of this study is the percentage increase in tissue oxygen saturation (StO2) following the administration of femoropopliteal nerve blocks and spinal anesthesia. StO2 will be measured at two locations below the knee (Points A and B) at different heights. Measurements will be taken at four time points: 10 minutes before the intervention (TI), and 5, 15, and 30 minutes after the intervention (T2, T3, T4). The goal is to assess and compare the changes in StO2 induced by each type of anesthesia.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Peripheral Arterial Disease', 'Subarachnoid Block', 'Femoropopliteal Block', 'Tissue Oxygen Saturation']}, 'descriptionModule': {'briefSummary': 'This pilot study investigates the effects of femoropopliteal and subarachnoid nerve blocks on tissue oxygen saturation (StO2) in patients with Peripheral Arterial Disease (PAD) during lower limb surgeries. Using Near-Infrared Spectroscopy (NIRS), the study compares changes in StO2 post-block. Although no significant differences were found between the two block types at most time points, subarachnoid blocks generally led to higher StO2 increases compared to femoropopliteal blocks, with significant differences observed at 5 and 15 minutes post-block.', 'detailedDescription': 'This pilot study explored the impact of femoropopliteal and subarachnoid nerve blocks on tissue oxygen saturation (StO2) in patients with Peripheral Arterial Disease (PAD) during lower limb surgeries, using Near-Infrared Spectroscopy (NIRS) for non-invasive monitoring. The study compared StO2 changes at baseline, 5, 15, and 30 minutes post-block in two groups: those receiving femoropopliteal blocks and those receiving subarachnoid blocks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18-80 years old who are scheduled to undergo lower limb debridement surgery.\n* Diagnosis of Peripheral Arterial Disease (PAD).\n* Lesion located below the knee.\n\nExclusion Criteria:\n\n* Consuming opioids before hospital admission.\n* Having allergies to the medications used in the study.\n* Presence of infection at the injection site.'}, 'identificationModule': {'nctId': 'NCT06702202', 'briefTitle': 'Effect of Subarachnoid Block and Femoropopliteal Block to Limb Perfusion in PAD Patients', 'organization': {'class': 'OTHER', 'fullName': 'Indonesia University'}, 'officialTitle': 'Comparison of the Effect of Subarachnoid Block and Femoropopliteal Block to Limb Perfusion in Patients with Peripheral Arterial Disease', 'orgStudyIdInfo': {'id': 'IndonesiaUAnes141124'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Femoropopliteal block (Group F)', 'description': 'Ultrasonography was performed using the Mindray DP-10 system with a linear transducer positioned at the inguinal fold to identify and visualize the femoral nerve, 10 ml mixture of local anesthetics ( Marcaine® \\[bupivacaine HCl\\] 0,5% and Xylocaine® \\[Lidocaine HCL\\] 2% = 2:1) were injected in-plane around the femoral nerve. For popliteal sciatic nerve blocks, linear transducer was placed transversally on the distal thigh to visualize Sciatic nerve just before branching, followed by the injection of 20 ml of the same mixture of local anesthetics through a 50 mm block needle in-plane', 'interventionNames': ['Drug: Mixture of local anesthetics']}, {'type': 'EXPERIMENTAL', 'label': 'Subarachnoid block (Group S)', 'description': 'Patients may assume either a sitting or lateral decubitus position, and subsequent to aseptic procedures, a G27 spinal needle will be introduced into the L3-4 interspinous space until clear cerebrospinal fluid visualization, followed by the injection of 2-2.5 ml of 0.5% hyperbaric Bupivacaine', 'interventionNames': ['Drug: 0.5% hyperbaric bupivacaine']}], 'interventions': [{'name': 'Mixture of local anesthetics', 'type': 'DRUG', 'description': 'Marcaine® (bupivacaine HCl) 0,5% and Xylocaine® (Lidocaine HCL) 2% = 2:1 Given in Femoropopliteal block group (Group F)', 'armGroupLabels': ['Femoropopliteal block (Group F)']}, {'name': '0.5% hyperbaric bupivacaine', 'type': 'DRUG', 'description': 'Given in Subarachnoid block group (Group S)', 'armGroupLabels': ['Subarachnoid block (Group S)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10430', 'city': 'Jakarta', 'state': 'DKI Jakarta', 'country': 'Indonesia', 'facility': 'Cipto Mangunkusumo Cental National Hospital', 'geoPoint': {'lat': -6.21462, 'lon': 106.84513}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Indonesia University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Aida Rosita Tantri', 'investigatorAffiliation': 'Indonesia University'}}}}