Ignite Creation Date:
2025-12-25 @ 4:25 AM
Ignite Modification Date:
2026-03-10 @ 9:20 PM
Study NCT ID:
NCT02951520
Status:
UNKNOWN
Last Update Posted:
2016-11-03
First Post:
2016-10-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Novel Single-puncture Triple Nerve Block; Sciatic, Obturator, Femoral Technique (SOFT), as a Sole Anesthesia for Knee Surgeries
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-11', 'lastUpdateSubmitDate': '2016-11-01', 'studyFirstSubmitDate': '2016-10-29', 'studyFirstSubmitQcDate': '2016-10-31', 'lastUpdatePostDateStruct': {'date': '2016-11-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-11-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'success rate', 'timeFrame': 'within the perioperative period'}]}, 'conditionsModule': {'keywords': ['Patients'], 'conditions': ['Arthroscopic Knee Ligament Reconstruction']}, 'descriptionModule': {'briefSummary': 'This study aims to describe and to evaluate the effectiveness (success rate) of a supine ultrasound (US) guided single-puncture sciatic, obturator and femoral neve block technique (SOFT block) in knee surgery.', 'detailedDescription': 'Under aseptic technique, all the patients will receive US-guided femoral, obturator and sciatic nerve blocks using a single puncture point. All blocks will be performed by an expert anesthetist. The femoral nerve will be blocked lateral to the femoral artery. The obturator nerve will be blocked after it exits the obturator canal (deep to pectineus muscle). While the sciatic nerve will be blocked deep (posterior) to the inferior border of quadratus femoris muscle. The motor block of the femoral, obturator and sciatic nerves and sensory block of the lateral femoral cutaneous nerve (LFCN) will be assessed before shifting the patient to the operating room.\n\nThe performance time, patient discomfort, technique success rate, the associated successful LFCN block and any complication will be recorded by the assistant. All patients were assessed neurologically before discharge and during the physiotherapy visits for 3 weak after surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients scheduled for arthroscopic knee ligament reconstruction\n\nExclusion Criteria:\n\n* BMI \\> 30 kg.m-2,\n* ASA physical state \\>II\n* Allergy to the used local anesthetics\n* Infection at the injection site\n* age \\<18y'}, 'identificationModule': {'nctId': 'NCT02951520', 'briefTitle': 'A Novel Single-puncture Triple Nerve Block; Sciatic, Obturator, Femoral Technique (SOFT), as a Sole Anesthesia for Knee Surgeries', 'organization': {'class': 'OTHER', 'fullName': 'Healthpoint Hospital'}, 'orgStudyIdInfo': {'id': 'REC 001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SOFT block', 'description': 'Fifty patients will form the study group (one group). All the patients will receive supine ultrasound guided (US) sciatic, obturator, femoral nerve block technique using a single skin puncture (SOFT block).', 'interventionNames': ['Procedure: new technique for lower limb nerve blocks using a single skin puncture (SOFT block)']}], 'interventions': [{'name': 'new technique for lower limb nerve blocks using a single skin puncture (SOFT block)', 'type': 'PROCEDURE', 'description': 'The patients will be in supine position. The block needle will be inserted at the inguinal crease (medial to the femoral vein) and advanced towards the femoral nerve, then redirected towards the obturator nerve (deep to the pectineus muscle). Lastly, it will be redirected posteriorly towards the sciatic nerve (deep to the quadratus femoris muscle). A ropivacaine-lidocaine-epinephrine mixture will be used to block these nerves. The block success rate (painless surgery), performance time and patient discomfort will be recorded.', 'armGroupLabels': ['SOFT block']}]}, 'contactsLocationsModule': {'locations': [{'zip': '112308', 'city': 'Abu Dhabi', 'state': 'Abu Dhabi Emirate', 'status': 'RECRUITING', 'country': 'United Arab Emirates', 'contacts': [{'name': 'Sabah Zahooruddin', 'role': 'CONTACT', 'email': 's.zahooruddin@healthpoint.ae', 'phone': '+971 2 4921304'}], 'facility': 'Healthpoint Hospital', 'geoPoint': {'lat': 24.45118, 'lon': 54.39696}}], 'centralContacts': [{'name': 'Ahmad M Taha, MD', 'role': 'CONTACT', 'email': 'ahmadtaha_1@yahoo.com', 'phone': '00971508297326'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Healthpoint Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Consultant of anesthesia', 'investigatorFullName': 'Ahmad Muhammad Taha', 'investigatorAffiliation': 'Healthpoint Hospital'}}}}