[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT04930887":3,"trial-entities:NCT04930887":94,"trial-summary:NCT04930887":101},{"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":25,"study_type":26,"primary_purpose":27,"phases":28,"enrollment_info":30,"interventions":33,"primary_outcomes":44,"secondary_outcomes":49,"sex":53,"minimum_age":54,"maximum_age":55,"healthy_volunteers":15,"eligibility_criteria":56,"std_ages":67,"locations":70,"central_contacts":85,"overall_officials":89,"references":92,"see_also_links":93},"NCT04930887","60832","Clinical Trial of Endoscopically Guided Injection of Exparel (Bupivacaine) for the Treatment of Craniofacial Pain","Prospective, Randomized, Double-blinded, Placebo-controlled, Cross-over Trial of Endoscopically Guided Injection of Exparel (Bupivacaine) Towards the Ipsilateral Pterygopalatine Fossa for the Treatment of Craniofacial Pain","RECRUITING","2030-06","2026-04","2026-04-27","2023-02-01","Stanford University","OTHER",false,"Exparel has a proven efficacy in providing pain relief for up to 72 hours with a single-dose administration at surgical sites. The study aims to evaluate the effectiveness of endoscopically-guided injection of Exparel (Bupivacaine) for the treatment of craniofacial pain. This study would be conducted in a prospective, randomized, double-blinded, placebo- controlled, and cross-over fashion. We aim to investigate whether the administration of Exparel (Bupivacaine) to the lateral nasal wall may positively impact craniofacial pain and functional outcomes, in patients who experience relief with the topical application of Lidocaine (routinely given prior to almost all ENT endoscopy).",null,[19,20,21,22,23,24],"Craniofacial Pain","Migraine","Cluster Headache","Trigeminal Autonomic Cephalgia","Sphenopalatine Ganglion Neuralgia","Paroxysmal Hemicrania",[],"INTERVENTIONAL","TREATMENT",[29],"PHASE2",{"count":31,"type":32},15,"ESTIMATED",[34,40],{"type":35,"name":36,"description":37,"armGroupLabels":38},"DRUG","Exparel (Bupivacaine Liposome)","Non-opioid postsurgical analgesic used in the management of postsurgical pain; 133 mg\u002F10 mL (13.3 mg\u002FmL) single-dose vial (per Pacira), study administers 3cc bilaterally",[39],"Exparel",{"type":35,"name":41,"description":42,"armGroupLabels":43},"Saline","Prescription medicine used for fluid and electrolyte replenishment for intravenous administration; Exparel-matched Placebo treatment",[41],[45],{"measure":46,"description":47,"timeFrame":48},"Change of Pain Score","Scores range from 0-10 (0=no pain, 10=worst pain)","Baseline to day 21",[50],{"measure":51,"description":52,"timeFrame":48},"Change of Associated Symptoms","Changes of associated symptoms, including nausea, photophobia, use of rescue medication, relapse of headache, and\u002For change in headache disability scores","ALL","18 Years","80 Years",{"inclusion":57,"exclusion":59,"raw_text":66},[58],"Patients with a chief complaint of craniofacial pain (migraine, cluster headache, trigeminal autonomic cephalgia, sphenopalatine ganglioneuraligia, paroxysmal hemicrania) who has Stanford Pain \\& ENT clinic visit",[60,61,62,63,64,65],"age \\\u003C18 or \\>80","pregnant women","economically disadvantaged (not able to afford clinic visits\u002Ftreatments)","decisionally impaired (unable to obtain informed consent)","has allergy to bupivacaine","unable or unwilling to participate plans to participate in another clinical study at any time during this study","Inclusion Criteria:\n\n* Patients with a chief complaint of craniofacial pain (migraine, cluster headache, trigeminal autonomic cephalgia, sphenopalatine ganglioneuraligia, paroxysmal hemicrania) who has Stanford Pain \\& ENT clinic visit\n\nExclusion Criteria:\n\n* age \\\u003C18 or \\>80\n* pregnant women\n* economically disadvantaged (not able to afford clinic visits\u002Ftreatments)\n* decisionally impaired (unable to obtain informed consent)\n* has allergy to bupivacaine\n* unable or unwilling to participate plans to participate in another clinical study at any time during this study",[68,69],"ADULT","OLDER_ADULT",[71],{"facility":72,"status":8,"city":73,"state":74,"zip":75,"country":76,"contacts":77,"geoPoint":82},"Peter H Hwang","Stanford","California","94304","United States",[78],{"name":72,"role":79,"phone":80,"email":81},"CONTACT","6503809590","hwangph@stanford.edu",{"lat":83,"lon":84},37.42411,-122.16608,[86],{"name":87,"role":79,"phone":88,"email":81},"Peter Hwang, MD","(650) 723-5281",[90],{"name":87,"affiliation":13,"role":91},"PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":95,"biomarkers":100},[21,96,20,97,98,99],"Craniofacial pain","Paroxysmal hemicrania","Sphenopalatine neuralgia","Trigeminal Autonomic Cephalalgia",[],{"nct_id":4,"found":102,"summary":103,"prompt_version":113},true,{"design":104,"status":105,"heading":106,"summary":107,"follow_up":108,"word_count":109,"commitments":110,"compensation":111,"drugs_mentioned":112},"This is a randomized, double-blinded, placebo-controlled, and cross-over study involving about 15 participants. This means you will randomly receive either Exparel or a placebo, and neither you nor your doctor will know which you received.","completed","Clinical Trial of Exparel for Craniofacial Pain","This study is testing if an injection of Exparel (bupivacaine), a non-opioid pain reliever, can help people with craniofacial pain, including migraines, cluster headaches, and other severe head pains. Researchers will inject Exparel or a saline placebo into the side of the nose using a special camera (endoscope). The goal is to see if Exparel can reduce your pain score over 21 days. You may be able to join if you are 18-80 years old, have craniofacial pain, and have had a visit to the Stanford Pain & ENT clinic. The study is currently unclear on its recruitment status and plans to enroll 15 participants.","Your pain score will be measured from the start of the study until day 21.",105,"Not specified in the trial record.","Not stated in the trial record.",[41],"v2"]