Ignite Creation Date:
2025-12-24 @ 9:43 PM
Ignite Modification Date:
2026-01-01 @ 4:13 AM
Study NCT ID:
NCT06974032
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-05-15
First Post:
2025-05-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Empathy Through Pain Control: Lidocaine Gel vs. Placebo Prior to IUD Placement
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D059787', 'term': 'Acute Pain'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C008371', 'term': 'phenylmercury borate'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER'], 'maskingDescription': 'Participants will not know their group assignment. Clinicians will not know which group the participant is in. The gel will be prepared by another member of the research team.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Two-armed double-blind, randomized controlled'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 68}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-06-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2028-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-07', 'studyFirstSubmitDate': '2025-05-07', 'studyFirstSubmitQcDate': '2025-05-07', 'lastUpdatePostDateStruct': {'date': '2025-05-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-05-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain scores during IUD placement procedure', 'timeFrame': 'From speculum placement to 5 minutes post-procedure', 'description': 'Does 2% lidocaine jelly decrease pain of paracervical block injection before IUD placement procedures among nulliparous women? Pain will be measured on a 10-cm Visual Analog Scale (VAS) with score points ranging from 0-10, where 0 means "No pain" and 10 means "Worst pain possible."'}, {'measure': 'Patient perceptions of clinician empathy', 'timeFrame': 'From pre-procedure baseline to 5 minutes post-procedure', 'description': 'What is the relationship between pain and feelings about clinician empathy? Empathy will be measured through answers to the 10-question Consultation and Relational Empathy (CARE) Measure. Each question is answered by a 5-point scale of how well the patient believes their clinician to be at various types of empathetic gestures, where 1 equals "poor" and 5 equals "excellent."'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Contraception', 'Pain, Acute', 'Anesthesia, Local']}, 'referencesModule': {'references': [{'pmid': '33196038', 'type': 'BACKGROUND', 'citation': 'Chin J, Kaneshiro B, Elia J, Raidoo S, Savala M, Soon R. Buffered lidocaine for paracervical blocks in first-trimester abortions: a randomized controlled trial. Contracept X. 2020 Oct 18;2:100044. doi: 10.1016/j.conx.2020.100044. eCollection 2020.'}, {'pmid': '24879075', 'type': 'BACKGROUND', 'citation': 'Azizkhani R, Forghani M, Maghami-Mehr A, Masomi B. The effects of injections of warmed bicarbonate-buffered Lidocaine as a painkiller for patients with trauma. J Inj Violence Res. 2015 Jul;7(2):87-8. doi: 10.5249/jivr.v7i2.523. Epub 2013 Dec 12. No abstract available.'}, {'pmid': '30095776', 'type': 'BACKGROUND', 'citation': 'Mody SK, Farala JP, Jimenez B, Nishikawa M, Ngo LL. Paracervical Block for Intrauterine Device Placement Among Nulliparous Women: A Randomized Controlled Trial. Obstet Gynecol. 2018 Sep;132(3):575-582. doi: 10.1097/AOG.0000000000002790.'}, {'pmid': '22771049', 'type': 'BACKGROUND', 'citation': 'Welch MN, Czyz CN, Kalwerisky K, Holck DE, Mihora LD. Double-blind, bilateral pain comparison with simultaneous injection of 2% lidocaine versus buffered 2% lidocaine for periocular anesthesia. Ophthalmology. 2012 Oct;119(10):2048-52. doi: 10.1016/j.ophtha.2012.05.029. Epub 2012 Jul 6.'}, {'pmid': '20090482', 'type': 'BACKGROUND', 'citation': 'Narvaez J, Wessels I, Bacon G, Chin VR, Baqai WK, Zimmerman GJ. Prospective randomized evaluation of short-term complications when using buffered or unbuffered lidocaine 1% with epinephrine for blepharoplasty surgery. Ophthalmic Plast Reconstr Surg. 2010 Jan-Feb;26(1):33-5. doi: 10.1097/IOP.0b013e3181b80c13.'}, {'pmid': '23611375', 'type': 'BACKGROUND', 'citation': 'Hobeich P, Simon S, Schneiderman E, He J. A prospective, randomized, double-blind comparison of the injection pain and anesthetic onset of 2% lidocaine with 1:100,000 epinephrine buffered with 5% and 10% sodium bicarbonate in maxillary infiltrations. J Endod. 2013 May;39(5):597-9. doi: 10.1016/j.joen.2013.01.008. Epub 2013 Mar 20.'}, {'pmid': '26253800', 'type': 'BACKGROUND', 'citation': 'Harreld TK, Fowler S, Drum M, Reader A, Nusstein J, Beck M. Efficacy of a Buffered 4% Lidocaine Formulation for Incision and Drainage: A Prospective, Randomized, Double-blind Study. J Endod. 2015 Oct;41(10):1583-8. doi: 10.1016/j.joen.2015.06.017. Epub 2015 Aug 4.'}, {'pmid': '22325115', 'type': 'BACKGROUND', 'citation': 'Maguire K, Davis A, Rosario Tejeda L, Westhoff C. Intracervical lidocaine gel for intrauterine device insertion: a randomized controlled trial. Contraception. 2012 Sep;86(3):214-9. doi: 10.1016/j.contraception.2012.01.005. Epub 2012 Feb 9.'}, {'pmid': '24012096', 'type': 'BACKGROUND', 'citation': 'Allen RH, Raker C, Goyal V. Higher dose cervical 2% lidocaine gel for IUD insertion: a randomized controlled trial. Contraception. 2013 Dec;88(6):730-6. doi: 10.1016/j.contraception.2013.07.009. Epub 2013 Aug 1.'}]}, 'descriptionModule': {'briefSummary': "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 lidocaine-infused gel and non-medicated gel inserted into the vagina before paracervical block and IUD placement for nulliparous women.", 'detailedDescription': "Lidocaine Jelly is a substance that has been approved by the Food and Drug Administration (FDA). At UCSD and other places, it is not currently standard practice for people with prior deliveries birth to receive any sort of vaginal jelly before paracervical block prior to IUD placement.\n\nParticipants who take part in this study, may receive 6cc of 2% lidocaine gel or 6cc of a non-medicated gel in the vagina before a paracervical block for IUD placement.\n\nThroughout the local anesthetic and intrauterine device (IUD) placement procedure, research team members will present participants with questionnaires to complete to assess participants' pain, participants' satisfaction with the procedure, and how much empathy participants feel the clinician has shown."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Ability to provide informed consent\n2. Women presenting for 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'}, 'identificationModule': {'nctId': 'NCT06974032', 'acronym': 'EPIC3', 'briefTitle': 'Empathy Through Pain Control: Lidocaine Gel vs. Placebo Prior to IUD Placement', 'organization': {'class': 'OTHER', 'fullName': 'University of California, San Diego'}, 'officialTitle': 'Expanding the Use of Paracervical Block for IUD Placements and Adding a Compassionate Care Assessment- Aim 3', 'orgStudyIdInfo': {'id': '812588'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '2% lidocaine gel (Xylocaine)', 'description': 'Experimental group: will receive 6cc of 2 lidocaine gel (Xylocaine) administered vaginally before paracervical block for IUD placement', 'interventionNames': ['Drug: Xylocaine jelly 2%']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Non-Medicated Gel (Surgilube)', 'description': 'Placebo group: will receive 6cc of non-medicated (surgilube) gel administered vaginally before paracervical block for IUD placement', 'interventionNames': ['Drug: Surgilube']}], 'interventions': [{'name': 'Xylocaine jelly 2%', 'type': 'DRUG', 'description': 'To determine if a 6cc of 2% lidocaine jelly decreases pain of paracervical block injection before IUD placement in nulliparous women', 'armGroupLabels': ['2% lidocaine gel (Xylocaine)']}, {'name': 'Surgilube', 'type': 'DRUG', 'description': 'To determine if the placebo gel increases pain of paracervical block injection before IUD placement in nulliparous women', 'armGroupLabels': ['Non-Medicated Gel (Surgilube)']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Marisa Hildebrand, MPH', 'role': 'CONTACT', 'email': 'mchildeb@health.ucsd.edu', 'phone': '(858) 657-8745'}], 'overallOfficials': [{'name': 'Sheila K Mody, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UC San Diego'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, San Diego', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Sheila Mody', 'investigatorAffiliation': 'University of California, San Diego'}}}}