Ignite Creation Date:
2025-12-24 @ 12:03 PM
Ignite Modification Date:
2026-02-23 @ 6:25 AM
Study NCT ID:
NCT02702661
Status:
COMPLETED
Last Update Posted:
2016-03-11
First Post:
2016-02-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
PRCT of FICB vs LAI for Hip Arthroscopy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D057925', 'term': 'Femoracetabular Impingement'}], 'ancestors': [{'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077554', 'term': 'Levobupivacaine'}], 'ancestors': [{'id': 'D002045', 'term': 'Bupivacaine'}, {'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 46}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-03', 'completionDateStruct': {'date': '2014-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-03-10', 'studyFirstSubmitDate': '2016-02-24', 'studyFirstSubmitQcDate': '2016-03-03', 'lastUpdatePostDateStruct': {'date': '2016-03-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-03-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Level of pain as assessed by Numeric Pain Score', 'timeFrame': '6 hours after surgery'}], 'secondaryOutcomes': [{'measure': 'Frequency of morphine consumed', 'timeFrame': '1 and 24 hours after surgery'}, {'measure': 'Total dose of morphine consumed', 'timeFrame': '1 and 24 hours after surgery'}, {'measure': 'Total dose of codeine consumed', 'timeFrame': '1 and 24 hours after surgery'}, {'measure': 'Nausea and Vomiting', 'timeFrame': '1 and 24 hours after surgery'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Fascia Iliaca Block', 'Local Anaesthetic Infiltration', 'Hip Arthroscopy'], 'conditions': ['Femoroacetabular Impingement']}, 'descriptionModule': {'briefSummary': 'A prospective randomised controlled trial involving patients undergoing hip arthroscopy. Participants were randomised to receiving either Fascia Iliaca Compartment Block (FICB) or Local Anaesthetic Infiltration (LAI) of the portal tracts with local anaesthetic. Supplemental analgesia was also used in both groups on an on-demand basis. Pain level is assessed at 1,3,6, and 24 hours post surgery. The primary outcome measure was the post-operative level of pain as assessed by Numeric Pain Score 6 hours after surgery. Secondary outcome measures were the frequency and the dose of morphine and other medications consumed at 1 and 24 hours after surgery as well as any other adverse events relating to pain or medications used for pain relief in both the groups.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients over the age of 18 years\n* Primary elective hip arthroscopy on a native hip for combined soft tissue injuries and FAI pathology\n* Able to read, write and communicate in English\n\nExclusion Criteria:\n\n* Patients who did not want to be involved in the Trial\n* Unable to give informed consent\n* Previous hip surgery\n* Patients younger than 18 years of age\n* Chronic opioids users\n* Patients known to have an allergy or intolerance to local anaesthetic agents or none steroidal anti-inflammatory medications'}, 'identificationModule': {'nctId': 'NCT02702661', 'briefTitle': 'PRCT of FICB vs LAI for Hip Arthroscopy', 'organization': {'class': 'OTHER', 'fullName': 'Cambridge University Hospitals NHS Foundation Trust'}, 'officialTitle': 'Fascia Iliaca Compartment Block and Local Anaesthetic Infiltration for Pain Control Following Hip Arthroscopic Surgery', 'orgStudyIdInfo': {'id': 'A092336'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Procedure - FICB', 'description': 'Fascia Iliaca Block following Hip Arthroscopy - Drug - Levobupivacaine 0.125% - 40ml', 'interventionNames': ['Procedure: Fascia Iliaca Compartment Block (FICB)', 'Drug: Levobupivacaine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Procedure - LAI', 'description': 'Local Anaesthetic Infiltration following Hip Arthroscopy - Drug - Levobupivacaine 0.125% - 40ml', 'interventionNames': ['Procedure: Local Anaesthetic Infiltration (LAI)', 'Drug: Levobupivacaine']}], 'interventions': [{'name': 'Fascia Iliaca Compartment Block (FICB)', 'type': 'PROCEDURE', 'description': 'Fascia Iliaca Compartment Block', 'armGroupLabels': ['Procedure - FICB']}, {'name': 'Local Anaesthetic Infiltration (LAI)', 'type': 'PROCEDURE', 'description': 'Local Anaesthetic Infiltration (LAI) of the portal tracts', 'armGroupLabels': ['Procedure - LAI']}, {'name': 'Levobupivacaine', 'type': 'DRUG', 'description': 'Levobupivacaine 0.125% - 40ml', 'armGroupLabels': ['Procedure - FICB', 'Procedure - LAI']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Vikas Khanduja, MA, FRCS (Orth)', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Cambridge University Hospitals NHS Foundation Trust'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cambridge University Hospitals NHS Foundation Trust', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Consultant Orthopaedic Surgeon & Associate Lecturer', 'investigatorFullName': 'Vikas Khanduja MA FRCS (Orth)', 'investigatorAffiliation': 'Cambridge University Hospitals NHS Foundation Trust'}}}}