Ignite Creation Date:
2025-12-25 @ 4:27 AM
Ignite Modification Date:
2025-12-26 @ 3:30 AM
Study NCT ID:
NCT01386320
Status:
COMPLETED
Last Update Posted:
2019-07-15
First Post:
2011-06-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Ultrasound Guided Ankle Block Versus Medial Forefoot Block for Forefoot Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-07', 'completionDateStruct': {'date': '2014-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-07-11', 'studyFirstSubmitDate': '2011-06-29', 'studyFirstSubmitQcDate': '2011-06-30', 'lastUpdatePostDateStruct': {'date': '2019-07-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-07-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time taken to carry out each local anaesthetic block', 'timeFrame': 'Over forty five minutes from the start of the study.', 'description': 'Time taken between opening sterile packs and completion of local anaesthetic block is measured by a blind observer.'}], 'secondaryOutcomes': [{'measure': 'Onset of local anaesthesia', 'timeFrame': 'Over thirty minutes from completion of the local anaesthetic block.', 'description': 'Following administration of the local block, development of anaesthesia will be measured looking at cold and pin-prick sensation by a blind observer.'}, {'measure': 'Duration of pain relief following local anaesthetic block.', 'timeFrame': 'Over 24 hours following surgery.', 'description': 'Pain relief will be assessed over 24 hours following surgery, to assess its duration and quality, by a blind observer.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['anaesthetic techniques, regional; surgery orthopaedic'], 'conditions': ['Pain Relief After Forefoot Surgery']}, 'descriptionModule': {'briefSummary': 'Forefoot surgery includes bunion surgery and similar reconstructive bone cutting surgery and is very painful. Local anaesthetic nerve blocks have been used for many years to help alleviate pain following this surgery. The present study aims to compare a new ultrasound guided nerve block to a well established nerve stimulator guided technique. Comparisons will include time taken to carry out the block, speed of onset of numbness and duration and quality of pain relief after surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Fit adult patients requiring forefoot surgery with bone cutting.\n\nExclusion Criteria:\n\n* Morbid obesity (BMI \\>40), known contraindications to regional anaesthesia'}, 'identificationModule': {'nctId': 'NCT01386320', 'acronym': 'USGAB', 'briefTitle': 'Ultrasound Guided Ankle Block Versus Medial Forefoot Block for Forefoot Surgery', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Hull University Teaching Hospitals NHS Trust'}, 'officialTitle': 'A Randomised, Blinded Comparison of an Ultrasound Guided Ankle Block Compared to a Nerve Stimulator Guided Ankle Block for Pain Relief After Forefoot Surgery.', 'orgStudyIdInfo': {'id': 'R0929 10/1304/1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Ultrasound guided ankle block', 'description': 'Subjects in this arm will be given an ultrasound guided ankle block prior to foot surgery.', 'interventionNames': ['Procedure: Ultrasound guided ankle block']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Medial forefoot block', 'description': 'Subjects in this arm will be given a nerve-stimulator guided forefoot block prior to anaesthesia and forefoot surgery', 'interventionNames': ['Procedure: Medial forefoot block']}], 'interventions': [{'name': 'Ultrasound guided ankle block', 'type': 'PROCEDURE', 'description': 'Under ultrasound guidance, block of the tibial nerve, superficial and deep branches of the common peroneal nerve and saphenous nerves will be carried out using 12 mls 0.5% levobupivacaine and 12 mls 0.75% levobupivacaine.', 'armGroupLabels': ['Ultrasound guided ankle block']}, {'name': 'Medial forefoot block', 'type': 'PROCEDURE', 'description': 'Using peripheral nerve stimulator guidance, the tibial and common peroneal nerves will be blocked ( plus the saphenous nerve ), using a total of 12 mls 0.75% levobupivacaine and 12 mls 0.5% levobupivacaine.', 'armGroupLabels': ['Medial forefoot block']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'HU16 5JQ', 'city': 'Hull', 'state': 'East Yorkshire', 'country': 'United Kingdom', 'facility': 'Castle Hill Hospital, Castle Road, Cottingham', 'geoPoint': {'lat': 53.7446, 'lon': -0.33525}}], 'overallOfficials': [{'name': 'Andrew J Coe, FRCA', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hull University Teaching Hospitals NHS Trust'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hull University Teaching Hospitals NHS Trust', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}