Ignite Creation Date:
2025-12-24 @ 11:47 AM
Ignite Modification Date:
2026-01-03 @ 5:08 PM
Study NCT ID:
NCT02623361
Status:
COMPLETED
Last Update Posted:
2018-12-27
First Post:
2015-12-01
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Prospective Analysis of Preoperative Fascia Iliaca Block for Hip Arthroscopy
Sponsor:
Organization:
Raw JSON
{'hasResults': True, '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'matthias.behrends@ucsf.edu', 'phone': '415 476 3761', 'title': 'Matthias Behrends, PI', 'organization': 'UCSF'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Sham', 'description': 'Sham Block: Sham Block by saline injection', 'otherNumAtRisk': 40, 'otherNumAffected': 0, 'seriousNumAtRisk': 40, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'FICB', 'description': 'Peripheral Nerve Block: Regional Anesthesia by Local Anesthetic Injection', 'otherNumAtRisk': 38, 'otherNumAffected': 0, 'seriousNumAtRisk': 38, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Numeric Pain Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sham', 'description': 'Sham Block: Sham Block by saline injection'}, {'id': 'OG001', 'title': 'FICB', 'description': 'Peripheral Nerve Block: Regional Anesthesia by Local Anesthetic Injection'}], 'classes': [{'categories': [{'measurements': [{'value': '7', 'spread': '2', 'groupId': 'OG000'}, {'value': '6', 'spread': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'within one hour after surgery', 'description': 'highest reported numeric score 0-10 in Post Anesthesia Care Unit (PACU) (primary endpoint) The NRS score is used to rate pain from 0 (no pain) to 10 (worst pain imaginable)', 'unitOfMeasure': 'units on the numeric rating scale (0-10)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Exclusion criteria for enrollment included age younger than 18 years, contraindications for regional anesthesia, pre-existing neurologic deficits of the lower extremity, and a history of chronic pain requiring chronic opioid medication.'}, {'type': 'SECONDARY', 'title': 'Leg Strength at Discharge From Ambulatory Center, Surgical Leg', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sham', 'description': 'Sham Block: Sham Block by saline injection'}, {'id': 'OG001', 'title': 'FICB', 'description': 'Peripheral Nerve Block: Regional Anesthesia by Local Anesthetic Injection'}], 'classes': [{'categories': [{'measurements': [{'value': '139', 'spread': '99', 'groupId': 'OG000'}, {'value': '41', 'spread': '61', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2 hours after surgery', 'description': 'measurement of quadriceps strength (Force) using a dynamometer', 'unitOfMeasure': 'Newton', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Patient Satisfaction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sham', 'description': 'Sham Block: Sham Block by saline injection'}, {'id': 'OG001', 'title': 'FICB', 'description': 'Peripheral Nerve Block: Regional Anesthesia by Local Anesthetic Injection'}], 'classes': [{'categories': [{'measurements': [{'value': '10', 'spread': '0', 'groupId': 'OG000'}, {'value': '10', 'spread': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '48 hours', 'description': 'patient questionaire, patients are contacted 48 h after surgery\n\npatient satisfaction is assessed using a questionnaire, applying a scale from 0 to 10, with 0 indicating "not satisfied at all" and 10 indicating "very satisfied"', 'unitOfMeasure': 'units on the numeric rating scale (0-10)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Sham', 'description': 'Sham Block: Sham Block by saline injection'}, {'id': 'FG001', 'title': 'FICB', 'description': 'Peripheral Nerve Block: Regional Anesthesia by Local Anesthetic Injection'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '40'}, {'groupId': 'FG001', 'numSubjects': '40'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '40'}, {'groupId': 'FG001', 'numSubjects': '38'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '78', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Sham', 'description': 'Sham Block: Sham Block by saline injection'}, {'id': 'BG001', 'title': 'FICB', 'description': 'Peripheral Nerve Block: Regional Anesthesia by Local Anesthetic Injection'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '78', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '32', 'spread': '9', 'groupId': 'BG000'}, {'value': '35', 'spread': '11', 'groupId': 'BG001'}, {'value': '34', 'spread': '10', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '78', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '78', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '40', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '78', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-12', 'completionDateStruct': {'date': '2017-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-12-06', 'studyFirstSubmitDate': '2015-12-01', 'resultsFirstSubmitDate': '2018-03-20', 'studyFirstSubmitQcDate': '2015-12-02', 'lastUpdatePostDateStruct': {'date': '2018-12-27', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-06-04', 'studyFirstPostDateStruct': {'date': '2015-12-07', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-07-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Numeric Pain Score', 'timeFrame': 'within one hour after surgery', 'description': 'highest reported numeric score 0-10 in Post Anesthesia Care Unit (PACU) (primary endpoint) The NRS score is used to rate pain from 0 (no pain) to 10 (worst pain imaginable)'}], 'secondaryOutcomes': [{'measure': 'Leg Strength at Discharge From Ambulatory Center, Surgical Leg', 'timeFrame': '2 hours after surgery', 'description': 'measurement of quadriceps strength (Force) using a dynamometer'}, {'measure': 'Patient Satisfaction', 'timeFrame': '48 hours', 'description': 'patient questionaire, patients are contacted 48 h after surgery\n\npatient satisfaction is assessed using a questionnaire, applying a scale from 0 to 10, with 0 indicating "not satisfied at all" and 10 indicating "very satisfied"'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Muscle Weakness | Patient', 'Pain']}, 'descriptionModule': {'briefSummary': 'Patients undergoing arthroscopic hip surgery have been shown to have significant post-operative pain that may delay discharge, recovery, and early mobilisation. A pre-operative regional anesthesia technique, the fascia iliaca block may be an effective method for acute post-operative analgesia.\n\nThis is a prospective, randomized controlled study of the preoperative fascia iliaca block for patients undergoing hip arthroscopy.\n\nThe enrolled patients will be randomized to receive either a fascia iliaca block with the local anesthetic ropivacaine or to have a sham block. All patients will receive a general anesthetic for the hip arthroscopy.', 'detailedDescription': "Arthroscopic hip surgery is used to diagnose and treat interior joint pathology. Although minimally invasive in nature, patients have considerable amount of pain postoperatively, leading to prolonged recovery room stay and increased opiate requirements. The investigators performed a retrospective chart review in patients who underwent hip arthroscopy at the UCSF Orthopedic Institute. 89% of the patients had pain immediate after surgery requiring opioid therapy. Regional anesthesia has previously been shown to reduce discomfort after hip arthroscopy. However, there is currently no safe, well-established ultrasound guided regional anesthesia technique for arthroscopic hip surgery. The fascia iliaca block has shown to decrease acute pain related with hip fractures, as well as pain related with knee arthroplasty. The ultrasound guided fascia iliaca block is easy to perform and has an excellent safety record. The investigators believe that the ultrasound guided fascia iliaca block improves pain control in patients undergoing arthroscopic hip surgery.\n\nPatients will receive a sham block group or a fascia iliaca block, performed in the preoperative area.\n\nPain scores and measurement of quadriceps strength will be assessed preoperatively and postoperatively. The patient will receive a pain diary consisting of pain scores, pain medication consumption, and a brief pain inventory. Within 48 hours postoperatively, an anesthesiologist will call the patient and review the patient's pain scores, pain medication consumption and brief pain inventory."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age at least 18 years old\n* American Society of Anesthesia physical classification I - III, scheduled for arthroscopic hip surgery\n\nExclusion Criteria:\n\n* Age younger than 18 years old\n* Non-English speaking\n* Contraindicated for regional nerve block (such as, but not limited to: coagulopathy, infection at site, allergy to local anesthetic)\n* Preexisting neurologic deficits of operative limb\n* Need for postoperative nerve function test\n* Inability to consent due to cognitive dysfunction\n* Chronic pain\n* Patient refusal.'}, 'identificationModule': {'nctId': 'NCT02623361', 'briefTitle': 'A Prospective Analysis of Preoperative Fascia Iliaca Block for Hip Arthroscopy', 'organization': {'class': 'OTHER', 'fullName': 'University of California, San Francisco'}, 'officialTitle': 'A Prospective Analysis of Preoperative Fascia Iliaca Block for Hip Arthroscopy', 'orgStudyIdInfo': {'id': 'FICB for hip athroscopy'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Sham', 'interventionNames': ['Drug: Sham Block']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Fascia Iliaca Compartment Block', 'interventionNames': ['Drug: Peripheral Nerve Block']}], 'interventions': [{'name': 'Peripheral Nerve Block', 'type': 'DRUG', 'description': 'Regional Anesthesia by Local Anesthetic Injection', 'armGroupLabels': ['Fascia Iliaca Compartment Block']}, {'name': 'Sham Block', 'type': 'DRUG', 'description': 'Sham Block by saline injection', 'armGroupLabels': ['Sham']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94158', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'Orthopedic Institute', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}], 'overallOfficials': [{'name': 'Matthias Behrends, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, San Francisco', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}