Ignite Creation Date:
2025-12-25 @ 4:31 AM
Ignite Modification Date:
2025-12-26 @ 3:34 AM
Study NCT ID:
NCT01454518
Status:
COMPLETED
Last Update Posted:
2013-03-11
First Post:
2011-10-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Local Infiltration Analgesia for Hip Arthroscopy
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': 'D000077330', 'term': 'Saline Solution'}], 'ancestors': [{'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-03', 'completionDateStruct': {'date': '2013-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-03-08', 'studyFirstSubmitDate': '2011-10-06', 'studyFirstSubmitQcDate': '2011-10-18', 'lastUpdatePostDateStruct': {'date': '2013-03-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-10-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Post operative opioid consumption.', 'timeFrame': 'Within 24 hours after surgery', 'description': 'Amount in milligrams of opioid consumption post surgery in the recovery room and for a 24 hour period.'}], 'secondaryOutcomes': [{'measure': 'Pain scores in recovery room.', 'timeFrame': 'Within 24 hours of the surgery', 'description': 'Mesures of pain score using numeric pain rating scale (0=no pain, 10=worst pain) completed by patient in recovery room and every 6 hours for a 24 hour period after discharge from recovery room.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['hip arthroscopy', 'post operative analgesia'], 'conditions': ['Pain']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to examine if ultrasound guided infiltration of local anesthetic solution around the hip joint will provide effective pain control after hip arthroscopy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* hip arthroscopy\n* ages 18-80\n\nExclusion Criteria:\n\n* history of neurological disease\n* diabetes\n* pregnancy\n* neuropathy\n* chronic narcotic use\n* allergy to local anesthetic solution\n* inability to give consent or cooperate with the study protocol'}, 'identificationModule': {'nctId': 'NCT01454518', 'briefTitle': 'Local Infiltration Analgesia for Hip Arthroscopy', 'organization': {'class': 'OTHER', 'fullName': 'Trinity Health Of New England'}, 'officialTitle': 'Effectiveness of Ultrasound Guided Hip Infiltration With Local Anesthetic Solution for Pain Control After Hip Arthroscopy', 'orgStudyIdInfo': {'id': '11-08-003'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Infiltration of local anesthetic', 'description': '30 ml of ropivacaine 0.5% infiltrated around lateral anterior and medial aspect of hip joint with ultrasound guidance.', 'interventionNames': ['Procedure: Infiltration of local anesthetic']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Normal Saline Injection', 'description': 'injection of 30ml normal saline infiltrated around lateral anterior and medial aspect of hip joint with ultrasound guidance.', 'interventionNames': ['Procedure: Normal Saline Injection']}], 'interventions': [{'name': 'Infiltration of local anesthetic', 'type': 'PROCEDURE', 'description': '30 ml of ropivacaine 0.5% infiltrated around lateral anterior and medial aspect of hip joint with ultrasound guidance.', 'armGroupLabels': ['Infiltration of local anesthetic']}, {'name': 'Normal Saline Injection', 'type': 'PROCEDURE', 'description': 'injection of 30ml normal saline infiltrated around lateral anterior and medial aspect of hip joint with ultrasound guidance.', 'armGroupLabels': ['Normal Saline Injection']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06105', 'city': 'Hartford', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Saint Francis Hospital and Medical Center', 'geoPoint': {'lat': 41.76371, 'lon': -72.68509}}], 'overallOfficials': [{'name': 'Sanjay Sinha, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Saint Francis Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Trinity Health Of New England', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}