Ignite Creation Date:
2025-12-25 @ 1:19 AM
Ignite Modification Date:
2026-02-23 @ 9:41 AM
Study NCT ID:
NCT02904993
Status:
TERMINATED
Last Update Posted:
2016-11-16
First Post:
2016-05-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study Comparing Regional Anesthetic Blocks and Periarticular Infiltration for the Management of Post-operative Pain After Direct Anterior Total Hip Arthroplasty
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007592', 'term': 'Joint Diseases'}], 'ancestors': [{'id': 'D009140', 'term': 'Musculoskeletal Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 9}}, 'statusModule': {'whyStopped': 'PI left the institution.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2016-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-11', 'completionDateStruct': {'date': '2016-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-11-15', 'studyFirstSubmitDate': '2016-05-16', 'studyFirstSubmitQcDate': '2016-09-13', 'lastUpdatePostDateStruct': {'date': '2016-11-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-09-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in pain score', 'timeFrame': 'post-operative to 7 days', 'description': 'Static and dynamic post-operative pain scores, measured on a 1 - 10 visual analogue scale.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Degenerative Joint Disease']}, 'descriptionModule': {'briefSummary': 'To compare two methods of post-operative pain management in patients undergoing total hip arthroplasty. There is a perception that the periarticular injections may not be as effective in controlling post-operative pain.\n\nBoth methods are current standard of care. The investigators want to compare the outcomes of each when patients are randomized to one of the methods compared to the other method of post-operative pain control.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subject scheduled for Direct Anterior unilateral total hip replacement\n* Weight ≥ 50 and ≤125 kg\n* Intact neurological exam\n* Cognitively intact with ability to sign consent\n\nExclusion Criteria:\n\n* Renal insufficiency with creatinine \\> 1.5 mg/dl\n* Allergic to any of the following : Ropivacaine, Epinephrine, Ketorolac, Morphine sulfate, NSAIDs, Tylenol, Neurontin, Morphine, Oxycodone or Dilaudid.\n* Subject taking regular narcotic medications prior to surgery (20mg/day Morphine equivalents for \\>7days)\n* Subject with prior open hip surgery who received regional anesthesia or periarticular injection for post op pain management.\n* Subject with contraindication for spinal anesthesia'}, 'identificationModule': {'nctId': 'NCT02904993', 'acronym': 'DA THA pain', 'briefTitle': 'Study Comparing Regional Anesthetic Blocks and Periarticular Infiltration for the Management of Post-operative Pain After Direct Anterior Total Hip Arthroplasty', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'Prospective Randomized Study Comparing Regional Anesthetic Blocks and Periarticular Infiltration for the Management of Post-operative Pain After Direct Anterior Total Hip Replacement', 'orgStudyIdInfo': {'id': '16-001154'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'L2 paravertebral block', 'description': 'regional anesthetic nerve blocks using an L2 paravertebral block with ropivacaine', 'interventionNames': ['Other: L2 paravertebral block']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'periarticular injection group', 'description': 'periarticular local injection into the periarticular soft tissues at the time of hip replacement using a combination of ropivacaine, epinephrine, ketorolac and morphine sulphate (periarticular injection group).', 'interventionNames': ['Other: periarticular injection group']}], 'interventions': [{'name': 'L2 paravertebral block', 'type': 'OTHER', 'description': 'nerve block group will receive preoperatively a L2 paravertebral block with indwelling catheter', 'armGroupLabels': ['L2 paravertebral block']}, {'name': 'periarticular injection group', 'type': 'OTHER', 'description': 'periarticular injection group will receive the injection cocktail towards the end of the total hip replacement prior to skin closure.', 'armGroupLabels': ['periarticular injection group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32224', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'Mayo Clinic in Florida', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}], 'overallOfficials': [{'name': 'John M Redmond', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Orthopedic Consultant', 'investigatorFullName': 'John M. Redmond, M.D.', 'investigatorAffiliation': 'Mayo Clinic'}}}}