[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100589892":3},{"organization":4,"armGroups":7,"interventions":40,"overallOfficials":63,"centralContacts":68,"locations":74,"responsibleParty":93,"collaborators":46,"id":96,"slug":97,"hasResults":98,"nctId":99,"briefTitle":100,"officialTitle":101,"acronym":102,"eligibilityCriteria":103,"healthyVolunteers":104,"sex":105,"minAge":106,"maxAge":107,"enrollmentInfo":108,"targetDuration":46,"studyType":111,"phases":112,"briefSummary":114,"conditions":115,"keywords":46,"overallStatus":76,"whyStopped":46,"lastUpdateSubmitDate":119,"lastUpdatePostDateStruct":120,"startDateStruct":123,"completionDateStruct":125,"leadSponsor":127,"locationsCount":128},{"fullName":5,"class":6},"University of California, San Diego","OTHER",[8,14,20,23,29,34],{"label":9,"type":10,"description":11,"interventionNames":12},"1a: Buffered lidocaine paracervical block","EXPERIMENTAL","Treatment group: will receive a 20-mL buffered (2 cc of sodium bicarbonate, 18 cc of 1% lidocaine) paracervical block administered before IUD placement. They will also receive 2 cc of buffered 1% lidocaine at the top of the cervix where the clinician places a tenaculum.",[13],"Drug: Buffered Lidocaine",{"label":15,"type":16,"description":17,"interventionNames":18},"1b: Capped needle","SHAM_COMPARATOR","Sham group: will receive a capped needle without any medication administered as paracervical block before IUD placement. They will receive 2 cc of buffered 1% lidocaine at the top of the cervix where the clinician places a tenaculum.",[19],"Other: Sham Comparator",{"label":21,"type":10,"description":11,"interventionNames":22},"2a: Buffered lidocaine paracervical block",[13],{"label":24,"type":25,"description":26,"interventionNames":27},"2b: Unbuffered lidocaine paracervical block","ACTIVE_COMPARATOR","Active comparator group: will receive a 20-mL unbuffered (1% lidocaine) paracervical block administered before IUD placement. They will also receive 2 cc of buffered 1% lidocaine at the top of the cervix where the clinician places a tenaculum.",[28],"Drug: Unbuffered lidocaine",{"label":30,"type":10,"description":31,"interventionNames":32},"3a: Medicated gel","Treatment group: will receive lidocaine-infused gel prior to administration of paracervical block.",[33],"Drug: Xylocaine jelly 2%",{"label":35,"type":36,"description":37,"interventionNames":38},"3b: Non-medicated gel","PLACEBO_COMPARATOR","Placebo group: will receive a non-medicated gel prior to administration of paracervical block.",[39],"Drug: Surgilube",[41,47,51,55,59],{"type":42,"name":43,"description":44,"armGroupLabels":45,"otherNames":46},"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",[9,21],null,{"type":6,"name":48,"description":49,"armGroupLabels":50,"otherNames":46},"Sham Comparator","None - capped needle will not be injected nor will it contain any medication.",[15],{"type":42,"name":52,"description":53,"armGroupLabels":54,"otherNames":46},"Unbuffered lidocaine","To determine if a 20 cc unbuffered (1% lidocaine) lidocaine paracervical block decreases pain with IUD placement",[24],{"type":42,"name":56,"description":57,"armGroupLabels":58,"otherNames":46},"Xylocaine jelly 2%","To determine if a Xylocaine jelly (2% infused lidocaine) decreases pain with paracervical block",[30],{"type":42,"name":60,"description":61,"armGroupLabels":62,"otherNames":46},"Surgilube","To determine if a placebo gel is inferior to lidocaine gel for pain with paracervical block",[35],[64],{"name":65,"affiliation":66,"role":67},"Sheila K Mody, MD, MPH","UC San Diego","PRINCIPAL_INVESTIGATOR",[69],{"name":70,"role":71,"phone":72,"phoneExt":46,"email":73},"Marisa Hildebrand, MPH","CONTACT","(858) 657-8745","mchildeb@health.ucsd.edu",[75],{"facility":5,"status":76,"city":77,"state":78,"zip":79,"country":80,"countryCode":81,"cosmosGeoPoint":82,"geoPoint":87,"contacts":88},"RECRUITING","La Jolla","California","92093","United States","US",{"type":83,"coordinates":84},"Point",[85,86],-117.2742,32.84727,{"lat":86,"lon":85},[89,91],{"name":70,"role":71,"phone":46,"phoneExt":46,"email":90},"familyplanningresearch@ucsd.edu",{"name":92,"role":67,"phone":46,"phoneExt":46,"email":46},"Sheila Mody, MD, MPH",{"type":67,"investigatorFullName":94,"investigatorTitle":95,"investigatorAffiliation":5,"oldNameTitle":46,"oldOrganization":46},"Sheila Mody","Professor","100589892","empathy-through-pain-control-lidocaine-paracervical-block-for-iud-placements-100589892",false,"NCT06960317","Empathy Through Pain Control: Lidocaine Paracervical Block for IUD Placements","Expanding the Use of Paracervical Block for IUD Placements and Adding a Compassionate Care Assessment","EPIC","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\n\nExclusion Criteria:\n\n1. No history of vaginal delivery\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":109,"type":110},204,"ESTIMATED","INTERVENTIONAL",[113],"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 participants opinions of their clinicians' empathy.\n\nThe investigators are inviting patients who arrive at their clinic visit seeking an IUD.\n\nUsually, at University of California, San Diego (UCSD), for patients who have never delivered a baby, clinicians use a buffered paracervical block for before IUD placement. The purpose of this research study is to investigate whether a \"buffered\" (2 cc of sodium bicarbonate, 18 cc of 1% lidocaine) paracervical block (numbing medication given on both sides of the cervix) is effective in reducing pain during IUD placement in individuals with prior C-sections, the difference between buffered and unbuffered for nulliparous patients, and whether a medicated gel reduces pain with the paracervical block.",[116,117,118],"Contraception","Pain, Acute","Anesthesia, Local","2025-06-10",{"date":121,"type":122},"2025-06-13","ACTUAL",{"date":124,"type":122},"2025-06-04",{"date":126,"type":110},"2028-06-30",{"name":5,"class":6},1]