Ignite Creation Date:
2025-12-24 @ 7:44 PM
Ignite Modification Date:
2025-12-30 @ 12:01 AM
Study NCT ID:
NCT04454203
Status:
RECRUITING
Last Update Posted:
2025-02-04
First Post:
2020-06-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Femoral Peri-arterial Local Anesthetic Injection Via Peri-arterial Perineural Catheter Reverses Tourniquet Associated Ischemic Hypertension
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D008619', 'term': 'Mepivacaine'}, {'id': 'D012965', 'term': 'Sodium Chloride'}], 'ancestors': [{'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-02-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2026-02-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-03', 'studyFirstSubmitDate': '2020-06-29', 'studyFirstSubmitQcDate': '2020-06-29', 'lastUpdatePostDateStruct': {'date': '2025-02-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-07-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-02-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in tourniquet hypertension as measured by systolic blood pressure', 'timeFrame': 'From time of injection to 30 minutes after injection', 'description': 'Infiltrating study drug to reverse intraoperative tourniquet hypertension'}], 'secondaryOutcomes': [{'measure': 'Pain Scores (NRS11)', 'timeFrame': 'Perioperative start until 2 hours after admission to PACU', 'description': 'The 11-point numeric scale ranges from \'0\' representing one pain extreme (e.g. "no pain") to \'10\' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable")'}, {'measure': 'Opioid consumption', 'timeFrame': 'Perioperative start until 2 hours after admission to PACU', 'description': 'Perioperative opioid consumption as measured in oral morphine equivalents (OMEs)'}, {'measure': 'Quadriceps motor function', 'timeFrame': '1 hour after extubation', 'description': 'Gross quadriceps motor function as measured by leg extension'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Perifemoral', 'Tourniquet', 'Mepivacaine', 'Tourniquet Hypertension'], 'conditions': ['Tourniquet Hypertension', 'Intraoperative Hypertension', 'Total Ankle Arthroplasty', 'Ankle Fusion']}, 'descriptionModule': {'briefSummary': 'The goal of this prospective randomized double-blind study is to determine if an ultrasound guided peri-arterial injection of local anesthetic (LA) superomedially the femoral artery via peripheral nerve catheter reverses ischemic hypertension associated with prolonged lower extremity tourniquet time.', 'detailedDescription': 'This is a research study to find out if injection of numbing medication by the large artery going down your leg will improve high blood pressure caused by the tourniquet.\n\nDepending on whether you enroll in this study, you may receive an injection of local anesthetic (numbing medication) or saline (salt water) by your femoral artery (the large artery going down your leg). This is to see how this injection impacts your blood pressure during surgery as the surgeons use a tourniquet (device that squeezes your leg) to help decrease the bleeding during surgery. Oftentimes the tourniquet causes your blood pressure to go up, but the numbing medication may help return your blood pressure close to its normal level. The rest of your anesthesia care, including other nerve blocks and general anesthetic, will be the same as it would be without participating in the study. You will be enrolled in this study for 24 hours.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\nPatients that will be included in the study are English speaking 18-75 year old ASA 1-3 patients undergoing total ankle arthroplasty.\n\nExclusion Criteria:\n\n1. ASA 4 or 5\n2. Diagnosis of chronic pain\n3. Daily chronic opioid use (over 3 months of continuous opioid use).\n4. Inability to communicate pain scores or need for analgesia.\n5. Infection at the site of block placement\n6. Age under 18 years old or greater than 75 years old\n7. Pregnant women (as determined by standard of care day-of surgery urine bHCG)\n8. Intolerance/allergy to local anesthetics\n9. Weight \\<50 kg\n10. Suspected, or known addiction to or abuse of illicit drug(s), prescription medicine(s), or alcohol within the past 2 years.\n11. Uncontrolled anxiety, schizophrenia, or other psychiatric disorder that, in the opinion of the investigator, may interfere with study assessments or compliance.\n12. Current or historical evidence of any clinically significant disease or condition that, in the opinion of the investigator, may increase the risk of surgery or complicate the subject's postoperative course"}, 'identificationModule': {'nctId': 'NCT04454203', 'briefTitle': 'Femoral Peri-arterial Local Anesthetic Injection Via Peri-arterial Perineural Catheter Reverses Tourniquet Associated Ischemic Hypertension', 'organization': {'class': 'OTHER', 'fullName': 'Duke University'}, 'officialTitle': 'Femoral Peri-arterial Local Anesthetic Injection Via Peri-arterial Perineural Catheter Reverses Tourniquet Associated Ischemic Hypertension', 'orgStudyIdInfo': {'id': 'Pro00104144'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Mepivacaine Block Group', 'description': 'Infiltration of local anesthetic (mepivacaine) above and beside the femoral artery through a perineural catheter.', 'interventionNames': ['Drug: Mepivacaine', 'Procedure: Perifemoral Injection of Local Anesthetic']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Saline Sham Group', 'description': 'Infiltration of salt water (saline) above and beside the femoral artery through a perineural catheter.', 'interventionNames': ['Drug: Saline', 'Procedure: Perifemoral Injection of Local Anesthetic']}], 'interventions': [{'name': 'Mepivacaine', 'type': 'DRUG', 'otherNames': ['Carbocaine'], 'description': 'An infiltration of mepivacaine superomedially to the femoral artery via perineural catheter.', 'armGroupLabels': ['Mepivacaine Block Group']}, {'name': 'Saline', 'type': 'DRUG', 'otherNames': ['Salt water placebo'], 'description': 'An infiltration of saline superomedially to the femoral artery via perineural catheter.', 'armGroupLabels': ['Saline Sham Group']}, {'name': 'Perifemoral Injection of Local Anesthetic', 'type': 'PROCEDURE', 'otherNames': ['Femoral Periarterial Injection'], 'description': 'Infiltration of mepivacaine superomedially to the formal artery via perineural catheter in an effort to numb the nerves that contribute to tourniquet hypertension intraoperatively.', 'armGroupLabels': ['Mepivacaine Block Group']}, {'name': 'Perifemoral Injection of Local Anesthetic', 'type': 'PROCEDURE', 'otherNames': ['Femoral Periarterial Injection'], 'description': 'Infiltration of saline superomedially to the formal artery via perineural catheter that should NOT numb the nerves that contribute to tourniquet hypertension intraoperatively.', 'armGroupLabels': ['Saline Sham Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'William M Bullock, MD, PhD', 'role': 'CONTACT', 'email': 'william.bullock@duke.edu', 'phone': '919-681-6437'}, {'name': 'Amanda Kumar, MD', 'role': 'CONTACT', 'email': 'amanda.kumar@duke.edu', 'phone': '919-681-6437'}, {'name': 'Amanda Kumar, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'William M Bullock, MD, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Jeff C Gadsden, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Duke University Hospital', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}], 'centralContacts': [{'name': 'William M Bullock, MD, PhD', 'role': 'CONTACT', 'email': 'william.bullock@duke.edu', 'phone': '919-681-6437'}, {'name': 'Jeff C Gadsden, MD', 'role': 'CONTACT', 'email': 'jeff.gadsden@duke.edu', 'phone': '919-681-6437'}], 'overallOfficials': [{'name': 'Amanda Kumar, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Duke University'}, {'name': 'William M Bullock, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Duke University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Individual participant data will not be shared; patients will be deidentified and no personal information or medical records used.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Duke University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}