[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100590945":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":36,"locations":26,"responsibleParty":42,"collaborators":26,"id":45,"slug":46,"hasResults":47,"nctId":48,"briefTitle":49,"officialTitle":49,"acronym":50,"eligibilityCriteria":51,"healthyVolunteers":52,"sex":53,"minAge":54,"maxAge":55,"enrollmentInfo":56,"targetDuration":26,"studyType":59,"phases":60,"briefSummary":62,"conditions":63,"keywords":26,"overallStatus":67,"whyStopped":26,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":26},{"fullName":5,"class":6},"University of California, San Diego","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Buffered lidocaine paracervical block","EXPERIMENTAL","Experimental groups: will receive a 20-mL buffered (2 cc of sodium bicarbonate, 18 cc of 1% lidocaine) paracervical block administered before IUD placement.",[13],"Drug: Buffered Lidocaine",{"label":15,"type":16,"description":17,"interventionNames":18},"Unbuffered lidocaine paracervical block","ACTIVE_COMPARATOR","Active comparator group: will receive a 20-mL unbuffered (20 cc of 1% lidocaine) paracervical block administered before IUD placement.",[19],"Drug: Lidocaine 1% Injectable Solution",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Buffered Lidocaine","To determine if a 20 cc buffered (2 cc of sodium bicarbonate, 18 cc of 1% lidocaine) lidocaine paracervical block decreases pain with IUD placement in nulliparous women",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Lidocaine 1% Injectable Solution","To determine if the unbuffered 1% lidocaine paracervical block offers any less pain control with IUD placement for nulliparous women",[15],[32],{"name":33,"affiliation":34,"role":35},"Sheila K Mody, MD, MPH","UC San Diego","PRINCIPAL_INVESTIGATOR",[37],{"name":38,"role":39,"phone":40,"phoneExt":26,"email":41},"Marisa Hildebrand, MPH","CONTACT","(858) 657-8745","mchildeb@health.ucsd.edu",{"type":35,"investigatorFullName":43,"investigatorTitle":44,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"Sheila Mody","Professor","100590945","empathy-through-pain-control-buffered-compared-to-unbuffered-1-lidocaine-during-iud-placement-100590945",false,"NCT06974019","Empathy Through Pain Control: Buffered Compared to Unbuffered 1% Lidocaine During IUD Placement","EPIC2","Inclusion Criteria:\n\n1. Ability to provide informed consent\n2. Women IUD placement for contraception or heavy menstrual bleeding\n3. Ages 18-50\n4. English-speaking\n5. Participants must not have a past medical history of substance use disorders, pain disorders, use of prescription pain medications or are found to be pregnant\n6. Nulliparous (never given birth)\n\nExclusion Criteria:\n\n1. History of ever giving birth\n2. Current use of prescription pain medication prior to procedure. Over-the-counter medications such as those containing ibuprofen, aspirin, acetaminophen, or naproxen are allowed.\n3. Diagnosed chronic pain condition\n4. Current pregnancy\n5. Known allergic reactions to components of the local anesthetic\n6. History of an IUD placement\n7. Current substance use or history of substance use\n8. Known contraindications to IUD, such as unexplained vaginal bleeding",true,"FEMALE","18 Years","50 Years",{"count":57,"type":58},68,"ESTIMATED","INTERVENTIONAL",[61],"NA","The goal of this research study is to learn more about how different uses of a numbing medication might affect pain levels while getting an IUD placed. The investigators are also studying patients' opinions of their clinicians' empathy.\n\nThe investigators are inviting patients who have never given birth who arrive at their clinic visit seeking an IUD.\n\nUsually, at University of California, San Diego (UCSD), for patients who have never delivered, clinicians numb both the sides of the cervix with a lidocaine-based paracervical block. The purpose of this research study is to compare perceptions of pain between buffered (2 cc of sodium bicarbonate, 18 cc of 1% lidocaine) vs. unbuffered paracervical block (20 cc 1% lidocaine) during IUD placement for nulliparous women.",[64,65,66],"Contraception","Pain, Acute","Anesthesia, Local","NOT_YET_RECRUITING","2025-05-07",{"date":70,"type":71},"2025-05-15","ACTUAL",{"date":73,"type":58},"2025-06-01",{"date":75,"type":58},"2028-06-30",{"name":5,"class":6}]