Ignite Creation Date:
2025-12-25 @ 5:03 AM
Ignite Modification Date:
2025-12-26 @ 4:05 AM
Study NCT ID:
NCT07294118
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-19
First Post:
2025-05-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Infusion of Lidocaine and Steroids in Middle Meningeal Artery for Pain in Subarachnoid Hemorrhage
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013345', 'term': 'Subarachnoid Hemorrhage'}, {'id': 'D006261', 'term': 'Headache'}, {'id': 'D009293', 'term': 'Opioid-Related Disorders'}], 'ancestors': [{'id': 'D020300', 'term': 'Intracranial Hemorrhages'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D000079524', 'term': 'Narcotic-Related Disorders'}, {'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008012', 'term': 'Lidocaine'}, {'id': 'D003907', 'term': 'Dexamethasone'}], 'ancestors': [{'id': 'D000083', 'term': 'Acetanilides'}, {'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D011246', 'term': 'Pregnadienetriols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D013259', 'term': 'Steroids, Fluorinated'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 15}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2027-08-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-17', 'studyFirstSubmitDate': '2025-05-21', 'studyFirstSubmitQcDate': '2025-12-17', 'lastUpdatePostDateStruct': {'date': '2025-12-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-12-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2027-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Visual Analog Scale (VAS) Score', 'timeFrame': 'Baseline', 'description': 'The Visual Analog Scale (VAS) is a validated, subjective measure for assessing pain intensity. It consists of a 10-centimeter horizontal line anchored by two extremes: "no pain" (0 mm) and "worst imaginable pain" (100 mm). Participants indicate their pain level by marking a point along the line that corresponds to their current pain intensity. The score is determined by measuring the distance in millimeters from the "no pain" anchor to the participant\'s mark, yielding a score between 0 and 100 mm. Higher scores represent greater pain intensity.'}, {'measure': 'Visual Analog Scale (VAS) Score', 'timeFrame': 'Every 4 hours for 24 hours following the procedure', 'description': 'The Visual Analog Scale (VAS) is a validated, subjective measure for assessing pain intensity. It consists of a 10-centimeter horizontal line anchored by two extremes: "no pain" (0 mm) and "worst imaginable pain" (100 mm). Participants indicate their pain level by marking a point along the line that corresponds to their current pain intensity. The score is determined by measuring the distance in millimeters from the "no pain" anchor to the participant\'s mark, yielding a score between 0 and 100 mm. Higher scores represent greater pain intensity.'}], 'secondaryOutcomes': [{'measure': 'Analgesic Use by Category and Total Quantity (Non-Opiates) or Morphine Equivalents (Opiates) - Pre- and Post-Intervention', 'timeFrame': 'up to 6 months', 'description': 'To measure analgetic use by category and total quantity in the case of non-opiates, or morphine equivalents in the case of opiates, pre- and post-intervention. by category and total quantity in the case of non-opiates, or morphine equivalents in the case of opiates, pre- and post-intervention.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Subarachnoid Hemorrhage, Aneurysmal', 'Headache', 'Opiate Dependence', 'Opioid Use']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to learn if an infusion of lidocaine, with or without steroids, into the middle meningeal artery (MMA) helps relieve severe headaches in patients with spontaneous subarachnoid hemorrhage (SAH). It will also study the safety of this treatment.', 'detailedDescription': 'This protocol outlines a single-arm prospective cohort study evaluating the efficacy of endovascular infusion of lidocaine and steroids into the MMA for managing post-SAH pain (i.e., headaches) in patients with SAH with Hunt and Hess Grades 1-2. 15 patients will be enrolled into three groups of treatment: lidocaine, lidocaine/dexamethasone, and no injection. Pain outcomes will be evaluated using VAS at multiple timepoints, including during neurochecks postoperatively, to calculate a cumulative "total VAS score." Morphine equivalents will also be tracked to assess opioid needs over time.\n\nThe main questions it aims to answer are:\n\nDoes the infusion lower patients\' pain levels after SAH?\n\nDoes the infusion reduce the amount of opioids and other pain medications patients need?\n\nAre there any side effects or complications from the procedure?\n\nResearchers will compare three groups:\n\nPatients who receive lidocaine alone\n\nPatients who receive lidocaine with dexamethasone (a steroid)\n\nPatients who receive no infusion\n\nAll participants will:\n\nUndergo a standard brain angiogram (a routine imaging test for SAH)\n\nMay receive the medication during the angiogram, depending on their assigned group\n\nBe monitored closely for changes in pain and medication use\n\nComplete follow-up visits at 1, 3, and 6 months to track outcomes and side effects\n\nThis study may help find new, targeted ways to treat headaches in patients with SAH and reduce reliance on opioids.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥18 years.\n* Diagnosed with aneurysmal SAH, Hunt and Hess Grades 1-2.\n* Consent to study procedures and follow-up evaluations.\n\nExclusion Criteria:\n\n* Known allergies to lidocaine or steroids.\n* Arteriovenous malformations.\n* Dural Arteriovenous Fistulas.\n* Other significant intracranial pathologies.\n* Hemodynamic instability preventing safe intervention.\n* Previous MMA interventions.\n* Previous craniotomies or need for craniotomy.\n* Need for external ventricular drain.'}, 'identificationModule': {'nctId': 'NCT07294118', 'briefTitle': 'Infusion of Lidocaine and Steroids in Middle Meningeal Artery for Pain in Subarachnoid Hemorrhage', 'organization': {'class': 'OTHER', 'fullName': 'The University of Texas Medical Branch, Galveston'}, 'officialTitle': 'Endovascular Infusion of Lidocaine and Steroids in the Middle Meningeal Artery for Pain Management in Spontaneous Subarachnoid Hemorrhage Patients', 'orgStudyIdInfo': {'id': '25-0010'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Lidocaine (50 mg bilaterally)', 'description': 'The participants will receive 50 mg of lidocaine.', 'interventionNames': ['Drug: Lidocaine']}, {'type': 'EXPERIMENTAL', 'label': 'Lidocaine (50 mg) + Dexamethasone (10 mg bilaterally)', 'description': 'The participant will receive Lidocaine (50 mg) + Dexamethasone (10 mg bilaterally)', 'interventionNames': ['Drug: Lidocaine and Dexamethasone']}, {'type': 'NO_INTERVENTION', 'label': 'No injection (Control group)', 'description': 'The participant will not receive an injection.'}], 'interventions': [{'name': 'Lidocaine', 'type': 'DRUG', 'description': 'The participants will receive 50 mg of lidocaine.', 'armGroupLabels': ['Lidocaine (50 mg bilaterally)']}, {'name': 'Lidocaine and Dexamethasone', 'type': 'DRUG', 'description': 'The participants will receive 50 mg of lidocaine and 10 mg of dexamethasone one after the other.', 'armGroupLabels': ['Lidocaine (50 mg) + Dexamethasone (10 mg bilaterally)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77555-0158', 'city': 'Galveston', 'state': 'Texas', 'country': 'United States', 'contacts': [{'name': 'Matias Costa', 'role': 'CONTACT', 'email': 'mlcosta@utmb.edu', 'phone': '409-772-1011'}, {'name': 'Peter Kan, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Texas Medical Branch, Galveston', 'geoPoint': {'lat': 29.30135, 'lon': -94.7977}}], 'centralContacts': [{'name': 'Matias Costa', 'role': 'CONTACT', 'email': 'mlcosta@utmb.edu', 'phone': '409-772-1011'}], 'overallOfficials': [{'name': 'Kan Peter, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Texas Medical Branch, Galveston'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The University of Texas Medical Branch, Galveston', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}