Ignite Creation Date:
2025-12-25 @ 2:30 AM
Ignite Modification Date:
2025-12-27 @ 11:01 PM
Study NCT ID:
NCT03798834
Status:
COMPLETED
Last Update Posted:
2020-09-22
First Post:
2019-01-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Fascia Iliaca Block for Anesthesia in Lower Limb Thromboembolectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000775', 'term': 'Anesthesia, Spinal'}], 'ancestors': [{'id': 'D000765', 'term': 'Anesthesia, Conduction'}, {'id': 'D000758', 'term': 'Anesthesia'}, {'id': 'D000760', 'term': 'Anesthesia and Analgesia'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 112}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-11-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'completionDateStruct': {'date': '2019-04-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-09-19', 'studyFirstSubmitDate': '2019-01-08', 'studyFirstSubmitQcDate': '2019-01-08', 'lastUpdatePostDateStruct': {'date': '2020-09-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-01-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-02-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The proportion of the patients who did not require conversion to general anesthesia', 'timeFrame': 'for 30 minutes'}], 'secondaryOutcomes': [{'measure': 'Postoperative pain', 'timeFrame': 'For 24 hours after the intervention', 'description': 'The post-operative pain will recorded using 10-point Visual Analog Scale (VAS)'}, {'measure': 'Heart rate', 'timeFrame': 'For 6 hours after the intervention', 'description': 'changes in Heart rate'}, {'measure': 'mean arterial pressure (MAP', 'timeFrame': 'For 6 hours after the intervention', 'description': 'changes in mean arterial pressure (MAP'}, {'measure': 'hypotension', 'timeFrame': 'For 24 hours from the block', 'description': 'Incidents of hypotension'}, {'measure': 'Any observed adverse effects', 'timeFrame': 'over the 24 hours postoperative', 'description': 'ny adverse effects will be observed over the 24 hours postoperative for local skin hematoma ,sensory deficits or local bleeding'}, {'measure': 'bradycardia', 'timeFrame': 'For 24 hours from the block', 'description': 'Incidents if bradycardia'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Chronic Lower Limb Ischemia']}, 'descriptionModule': {'briefSummary': "The fascia iliaca block (FIB) is an anterior approach to block the lumbar plexus. It disturbed mainly to the anterior region of the thigh by blocking the femoral nerve (LFC) and the lateral femoral cutaneous nerve. Moreover, FIB may possibly be extended to the obturator, ilioinguinal, genitofemoral, lateral cutaneous nerve of the thigh and over the psoas muscle but, rarely reaches the lumbar plexus.\n\nThe fascia iliaca compartment could be detected by bony landmarks palpation and the loss of resistance technique. Feeling two tactile ''pops'' due to loss of resistance occurred during the needle passage through the fascia lata and the fascia iliaca. Ultrasound (US) guidance of FIB will increase the success rate and the efficacy of sensory blockade by decreasing the needed local anesthetic amount.", 'detailedDescription': 'This study was conducted to demonstrate the success incidence (to evaluate the efficacy) of preoperative 0.25% bupivacaine FIB as a sole anesthetic technique in thromboembolectomy of unilateral chronic lower limb ischemia compared to neuraxial anesthesiaas a primary goal. Intraoperative hemodynamics variation, postoperative pain score, total analgesic rescue requests and the total amount of systemic rescue analgesia used in the first postoperative day in addition to any detected postoperative complications were secondary goals. The hypothesis is that; FIB will provide adequate anesthesia as neuraxial anesthesia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ASA physical status I or II.\n\nExclusion Criteria:\n\n* Patients with previous same lower limb surgery\n* Neuromuscular disease\n* Severe cardiovascular disease\n* Any contraindications to regional anesthesia\n* patient refusal\n* coagulation abnormality\n* Known allergy to local anesthetics\n* Infection at the injection site'}, 'identificationModule': {'nctId': 'NCT03798834', 'briefTitle': 'Fascia Iliaca Block for Anesthesia in Lower Limb Thromboembolectomy', 'organization': {'class': 'OTHER', 'fullName': 'Mansoura University'}, 'officialTitle': 'Fascia Iliaca Block as an Anesthetic Technique for Thromboembolectomy of Chronic Lower Limb Ischemia', 'orgStudyIdInfo': {'id': 'R/17.07.111'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Fascia iliaca block (FIB)', 'description': 'ultrasound-guided Fascia iliaca block', 'interventionNames': ['Drug: Fascia iliaca block (FIB)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Spinal anesthesia', 'description': 'Spinal anaesthesia using 2 ml hyperbaric bupivacaine 0.5%', 'interventionNames': ['Other: Spinal anesthesia']}], 'interventions': [{'name': 'Fascia iliaca block (FIB)', 'type': 'DRUG', 'description': 'ultrasound-guided Fascia iliaca block', 'armGroupLabels': ['Fascia iliaca block (FIB)']}, {'name': 'Spinal anesthesia', 'type': 'OTHER', 'description': 'Spinal anaesthesia using 2 ml hyperbaric bupivacaine 0.5%', 'armGroupLabels': ['Spinal anesthesia']}]}, 'contactsLocationsModule': {'locations': [{'zip': '050', 'city': 'Al Mansurah', 'state': 'DK', 'country': 'Egypt', 'facility': 'Mansoura University', 'geoPoint': {'lat': 31.03637, 'lon': 31.38069}}], 'overallOfficials': [{'name': 'Reem A Elsharkawy, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Lecturer of Anesthesia and Surgical Intensive Care'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mansoura University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}