[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07294118":3,"trial-entities:NCT07294118":103,"trial-summary:NCT07294118":107},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":23,"study_type":24,"primary_purpose":25,"phases":26,"enrollment_info":28,"interventions":31,"primary_outcomes":43,"secondary_outcomes":50,"sex":55,"minimum_age":56,"maximum_age":57,"healthy_volunteers":58,"eligibility_criteria":59,"std_ages":74,"locations":77,"central_contacts":96,"overall_officials":98,"references":101,"see_also_links":102},"NCT07294118","25-0010","Infusion of Lidocaine and Steroids in Middle Meningeal Artery for Pain in Subarachnoid Hemorrhage","Endovascular Infusion of Lidocaine and Steroids in the Middle Meningeal Artery for Pain Management in Spontaneous Subarachnoid Hemorrhage Patients","RECRUITING","2027-08","2026-01","2026-01-09","2026-01-02","The University of Texas Medical Branch, Galveston","OTHER",true,"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.","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\u002Fdexamethasone, 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.",[19,20,21,22],"Subarachnoid Hemorrhage, Aneurysmal","Headache","Opiate Dependence","Opioid Use",[],"INTERVENTIONAL","TREATMENT",[27],"PHASE2",{"count":29,"type":30},15,"ESTIMATED",[32,38],{"type":33,"name":34,"description":35,"armGroupLabels":36},"DRUG","Lidocaine","The participants will receive 50 mg of lidocaine.",[37],"Lidocaine (50 mg bilaterally)",{"type":33,"name":39,"description":40,"armGroupLabels":41},"Lidocaine and Dexamethasone","The participants will receive 50 mg of lidocaine and 10 mg of dexamethasone one after the other.",[42],"Lidocaine (50 mg) + Dexamethasone (10 mg bilaterally)",[44,48],{"measure":45,"description":46,"timeFrame":47},"Visual Analog Scale (VAS) Score","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.","Baseline",{"measure":45,"description":46,"timeFrame":49},"Every 4 hours for 24 hours following the procedure",[51],{"measure":52,"description":53,"timeFrame":54},"Analgesic Use by Category and Total Quantity (Non-Opiates) or Morphine Equivalents (Opiates) - Pre- and Post-Intervention","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.","up to 6 months","ALL","18 Years","100 Years",false,{"inclusion":60,"exclusion":64,"raw_text":73},[61,62,63],"Age ≥18 years.","Diagnosed with aneurysmal SAH, Hunt and Hess Grades 1-2.","Consent to study procedures and follow-up evaluations.",[65,66,67,68,69,70,71,72],"Known allergies to lidocaine or steroids.","Arteriovenous malformations.","Dural Arteriovenous Fistulas.","Other significant intracranial pathologies.","Hemodynamic instability preventing safe intervention.","Previous MMA interventions.","Previous craniotomies or need for craniotomy.","Need for external ventricular drain.","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.",[75,76],"ADULT","OLDER_ADULT",[78],{"facility":79,"status":8,"city":80,"state":81,"zip":82,"country":83,"contacts":84,"geoPoint":93},"University of Texas Medical Branch, Galveston","Galveston","Texas","77555-0158","United States",[85,90],{"name":86,"role":87,"phone":88,"email":89},"Matias Costa","CONTACT","409-772-1011","mlcosta@utmb.edu",{"name":91,"role":92},"Peter Kan, MD","PRINCIPAL_INVESTIGATOR",{"lat":94,"lon":95},29.30135,-94.7977,[97],{"name":86,"role":87,"phone":88,"email":89},[99],{"name":100,"affiliation":79,"role":92},"Kan Peter, MD",[],[],{"nct_id":4,"conditions":104,"biomarkers":106},[105],"Subarachnoid Hemorrhage",[],{"nct_id":4,"found":15,"summary":108,"prompt_version":118},{"design":109,"status":110,"heading":111,"summary":112,"follow_up":113,"word_count":114,"commitments":115,"compensation":116,"drugs_mentioned":117},"This is a single-arm study, meaning all participants will receive an intervention, with a planned enrollment of 15 people. It compares three groups: lidocaine alone, lidocaine with dexamethasone, and no injection.","completed","Lidocaine and Steroids for Headache in Subarachnoid Hemorrhage","This study is looking at whether infusing lidocaine, with or without dexamethasone (a steroid), into a specific artery in the head can help reduce severe headaches in people who have had a subarachnoid hemorrhage (SAH). SAH is bleeding in the space around the brain. Researchers want to see if this treatment is safe and if it lowers pain levels and the need for opioid pain medications. You may be able to join if you are 18 to 100 years old, have been diagnosed with aneurysmal SAH (a type of SAH) with specific grades (Hunt and Hess Grades 1-2), and do not have allergies to the study medications or certain other brain conditions. The study plans to enroll 15 participants. Success will be measured by changes in your pain scores and how much pain medication you need.","You will have follow-up visits at 1, 3, and 6 months after the procedure to track outcomes and side effects.",136,"You will undergo a standard brain angiogram (an imaging test) and may receive the medication during this procedure. You will be monitored closely for changes in pain and medication use.","Not stated in the trial record.",[34],"v2"]