Ignite Creation Date:
2025-12-24 @ 5:24 PM
Ignite Modification Date:
2026-02-26 @ 7:49 PM
Study NCT ID:
NCT00696150
Status:
UNKNOWN
Last Update Posted:
2008-06-12
First Post:
2008-06-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Can the Femoral Nerve Block be Improved by Ultrasound Guidance?
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019220', 'term': 'High-Energy Shock Waves'}], 'ancestors': [{'id': 'D000069453', 'term': 'Ultrasonic Waves'}, {'id': 'D013016', 'term': 'Sound'}, {'id': 'D011840', 'term': 'Radiation, Nonionizing'}, {'id': 'D011827', 'term': 'Radiation'}, {'id': 'D055585', 'term': 'Physical Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 269}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2008-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-06', 'completionDateStruct': {'date': '2010-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2008-06-11', 'studyFirstSubmitDate': '2008-06-09', 'studyFirstSubmitQcDate': '2008-06-11', 'lastUpdatePostDateStruct': {'date': '2008-06-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-06-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'percentage of patients with effective regional analgesia', 'timeFrame': 'Induction of anaesthesia'}], 'secondaryOutcomes': [{'measure': 'hospital mortality', 'timeFrame': '1months after operation'}, {'measure': 'sensory function in lateral cutaneous nerve', 'timeFrame': '0mins, 10mins 20mins post insertion of local anaesthetic'}, {'measure': 'sensory function of femoral nerve', 'timeFrame': '0mins, 10mins, 20mins after insertion of local anesthetic'}, {'measure': 'sensory function of obturator nerve', 'timeFrame': '0mins, 10mins, 20mins after insertion of local anesthetic'}, {'measure': 'motor function of obturator nerve', 'timeFrame': '0mins, 10mins and 20minutes after insrtion of local anesthetic'}, {'measure': 'motor function of femoral nerve', 'timeFrame': '0mins,10mins and 20mins post insertion of local anesthetic'}, {'measure': 'acute mental test scores', 'timeFrame': '6hours and 24 hours post operatively'}, {'measure': 'total morphine dose administered', 'timeFrame': '6hours and 24 hours post operstively'}, {'measure': 'day first mobilise post operatively', 'timeFrame': 'post operatively 0-10 days'}, {'measure': 'patient satisfaction scores', 'timeFrame': '6 hours and 24hours post operatively'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['ultrasound', 'hip', 'pain'], 'conditions': ['Pain']}, 'descriptionModule': {'briefSummary': 'Studies have suggested a link with effective pain relief and reduced illness and death in very unwell patients. This study will determine the most effective method of injecting local anaesthetic around the nerves which supply the hip joint. Local anaesthetic will be injected around the hips nerve supply using either ultrasound, loss of resistance or electrical nerve stimulator to guide the positioning of the needle on patients due for elective total hip replacement. The patient will then be observed for 30 minutes and the patient ability to move or feel the upper leg will recorded. A standard anaesthetic and a hip replacement operation will then be performed. Standard pain relief protocols will be used the operation and after the operation. After the operation we will record the amount of morphine used and how happy the patients have been with their treatment at 6 hours after the operation and at 24 hours after the operation. The first day the patient is able to walk on their new hip replacement will also be recorded.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '35 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Elective primary total hip arthroplasty under general anaesthesia\n* ASA\\<=4\n* Able to give informed consent\n* Able to cooperate with sensory and motor testing of lower limb function\n\nExclusion Criteria:\n\n* Abnormal clotting screen (coagulopathy) or thrombocytopenia (\\<100,000)\n* Acute mental test score of \\<=7 at any time pre or post operatively\n* Allergy to local anaesthetic\n* Signs, symptoms or laboratory evidence of local infection or systemic sepsis\n* No pre-existing neurological deficit (sensory or motor) affecting lower limb\n* Patients with lower limb amputations'}, 'identificationModule': {'nctId': 'NCT00696150', 'briefTitle': 'Can the Femoral Nerve Block be Improved by Ultrasound Guidance?', 'organization': {'class': 'OTHER', 'fullName': 'NHS Greater Glasgow and Clyde'}, 'officialTitle': 'Can the Use of Ultrasound to Guide the Insertion of a Needle for an Anterior Psoas Compartment Nerve Block Increase Its Efficacy in Comparison to Traditional Techniques Utilising Loss of Resistance and Nerve Stimulation?', 'orgStudyIdInfo': {'id': 'ultrasound for hip # study-1'}, 'secondaryIdInfos': [{'id': 'CSO reference CAF/07/05'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'loss of resistance', 'description': 'Anterior psoas compartment nerve block inserted using loss of resistance', 'interventionNames': ['Procedure: loss of resistance']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'nerve stimulator', 'description': 'Anterior psoas compartment nerve block inserted using nerve stimulator', 'interventionNames': ['Procedure: determination of method with highest efficacy (ultrasound or nerve stimulator)', 'Procedure: nerve stimulator']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'ultrasound', 'description': 'Anterior psoas compartment nerve block inserted using ultrasound', 'interventionNames': ['Procedure: determination of method with highest efficacy (ultrasound or nerve stimulator)']}], 'interventions': [{'name': 'determination of method with highest efficacy (ultrasound or nerve stimulator)', 'type': 'PROCEDURE', 'description': 'Use of ultrasound to guide the insertion of anterior psoas compartment block', 'armGroupLabels': ['nerve stimulator', 'ultrasound']}, {'name': 'nerve stimulator', 'type': 'PROCEDURE', 'description': 'The use of the nerve stimulator to guide insertion of the anterior psoas compartment block', 'armGroupLabels': ['nerve stimulator']}, {'name': 'loss of resistance', 'type': 'PROCEDURE', 'description': 'Use of ultrasound to guide the insertion of anterior psoas compartment block', 'armGroupLabels': ['loss of resistance']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'G12 0YN', 'city': 'Glasgow', 'state': 'Lanarkshire', 'country': 'United Kingdom', 'contacts': [{'name': 'Graham Hilditch, MB chB, FRCA', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Gartnavel General hospital', 'geoPoint': {'lat': 55.86515, 'lon': -4.25763}}, {'zip': 'G4', 'city': 'Glasgow', 'state': 'Lanarkshire', 'country': 'United Kingdom', 'contacts': [{'name': 'Colin Rae, Mb chB, FRCA', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Glasgow Royal Infrimary', 'geoPoint': {'lat': 55.86515, 'lon': -4.25763}}, {'city': 'Glasgow', 'state': 'Lanarkshire', 'country': 'United Kingdom', 'contacts': [{'name': 'Micheal Higgins, MB chB, FRCA', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Golden Jubilee hospital', 'geoPoint': {'lat': 55.86515, 'lon': -4.25763}}, {'zip': 'PA2', 'city': 'Paisley', 'state': 'Renfrewshire', 'country': 'United Kingdom', 'contacts': [{'name': 'Paul Allcock, Mb ChB, FRCS', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Royal alexandra hospital', 'geoPoint': {'lat': 55.83173, 'lon': -4.43254}}], 'centralContacts': [{'name': 'Malcolm Watson, MBChB, MRCP, FRCA', 'role': 'CONTACT', 'email': 'mwatson@doctors.org.uk', 'phone': '01412116291'}], 'overallOfficials': [{'name': 'Malcolm watson, MB ChB FRCA', 'role': 'STUDY_CHAIR', 'affiliation': 'NHS Greater Glasgow and Clyde'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'NHS Greater Glasgow and Clyde', 'class': 'OTHER'}, 'collaborators': [{'name': 'Golden Jubilee National Hospital', 'class': 'OTHER_GOV'}], 'responsibleParty': {'oldNameTitle': 'Dr Erica Packard', 'oldOrganization': 'NHS Greater Glasgow and Clyde health board'}}}}