Ignite Creation Date:
2025-12-25 @ 3:20 AM
Ignite Modification Date:
2026-02-26 @ 12:00 PM
Study NCT ID:
NCT03362905
Status:
UNKNOWN
Last Update Posted:
2017-12-05
First Post:
2017-11-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Lidocaine for Pain Control During Intrauterine Device Insertion
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D008012', 'term': 'Lidocaine'}], 'ancestors': [{'id': 'D000083', 'term': 'Acetanilides'}, {'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This study will include 123 patients who are candidates for IUD contraception. The aim of the study will be explained to all patients and an informed written consent will be taken. After recruitment, patients will be randomized to the 3 study arms using computer generated randomization sheet using MedCalcc version 13 to receive any of: lidocaine spray, cream and injection'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 123}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2017-12-03', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-11', 'completionDateStruct': {'date': '2019-01-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-11-30', 'studyFirstSubmitDate': '2017-11-30', 'studyFirstSubmitQcDate': '2017-11-30', 'lastUpdatePostDateStruct': {'date': '2017-12-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-12-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-12-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain scores assessed by 10-point VAS scale', 'timeFrame': '1 year', 'description': 'VAS scores will be assessed on at three different points; baseline after application of speculum and analgesic administration, after grasping cervix with tenaculum, then following hysterometry and IUD insertion.'}], 'secondaryOutcomes': [{'measure': 'Patient satisfaction to IUD insertion', 'timeFrame': '1 year', 'description': 'Satisfaction will be assessed post-procedure using patient directed survey'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Lidocaine', 'Dosage forms', 'Pain scores'], 'conditions': ['IUD Insertion Complication']}, 'referencesModule': {'references': [{'pmid': '25759418', 'type': 'BACKGROUND', 'citation': 'Aksoy H, Aksoy U, Ozyurt S, Acmaz G, Babayigit M. Lidocaine 10% spray to the cervix reduces pain during intrauterine device insertion: a double-blind randomised controlled trial. J Fam Plann Reprod Health Care. 2016 Apr;42(2):83-7. doi: 10.1136/jfprhc-2014-100917. Epub 2015 Mar 10.'}, {'pmid': '25461369', 'type': 'BACKGROUND', 'citation': 'Buhling KJ, Hauck B, Dermout S, Ardaens K, Marions L. Understanding the barriers and myths limiting the use of intrauterine contraception in nulliparous women: results of a survey of European/Canadian healthcare providers. Eur J Obstet Gynecol Reprod Biol. 2014 Dec;183:146-54. doi: 10.1016/j.ejogrb.2014.10.020. Epub 2014 Oct 30.'}, {'pmid': '26222246', 'type': 'BACKGROUND', 'citation': "Lopez LM, Bernholc A, Zeng Y, Allen RH, Bartz D, O'Brien PA, Hubacher D. Interventions for pain with intrauterine device insertion. Cochrane Database Syst Rev. 2015 Jul 29;2015(7):CD007373. doi: 10.1002/14651858.CD007373.pub3."}, {'pmid': '23670222', 'type': 'BACKGROUND', 'citation': 'Gemzell-Danielsson K, Mansour D, Fiala C, Kaunitz AM, Bahamondes L. Management of pain associated with the insertion of intrauterine contraceptives. Hum Reprod Update. 2013 Jul-Aug;19(4):419-27. doi: 10.1093/humupd/dmt022. Epub 2013 May 12.'}, {'pmid': '24076534', 'type': 'BACKGROUND', 'citation': 'Bahamondes L, Mansour D, Fiala C, Kaunitz AM, Gemzell-Danielsson K. Practical advice for avoidance of pain associated with insertion of intrauterine contraceptives. J Fam Plann Reprod Health Care. 2014 Jan;40(1):54-60. doi: 10.1136/jfprhc-2013-100636. Epub 2013 Sep 27.'}, {'pmid': '28885425', 'type': 'BACKGROUND', 'citation': 'Akers AY, Steinway C, Sonalkar S, Perriera LK, Schreiber C, Harding J, Garcia-Espana JF. Reducing Pain During Intrauterine Device Insertion: A Randomized Controlled Trial in Adolescents and Young Women. Obstet Gynecol. 2017 Oct;130(4):795-802. doi: 10.1097/AOG.0000000000002242.'}, {'pmid': '25946948', 'type': 'BACKGROUND', 'citation': 'Tavakolian S, Doulabi MA, Baghban AA, Mortazavi A, Ghorbani M. Lidocaine-Prilocaine Cream as Analgesia for IUD Insertion: A Prospective, Randomized, Controlled, Triple Blinded Study. Glob J Health Sci. 2015 Jan 27;7(4):399-404. doi: 10.5539/gjhs.v7n4p399.'}, {'pmid': '24660158', 'type': 'BACKGROUND', 'citation': 'Golzari SE, Soleimanpour H, Mahmoodpoor A, Safari S, Ala A. Lidocaine and pain management in the emergency department: a review article. Anesth Pain Med. 2014 Feb 15;4(1):e15444. doi: 10.5812/aapm.15444. eCollection 2014 Feb.'}, {'pmid': '22770792', 'type': 'BACKGROUND', 'citation': 'Mody SK, Kiley J, Rademaker A, Gawron L, Stika C, Hammond C. Pain control for intrauterine device insertion: a randomized trial of 1% lidocaine paracervical block. Contraception. 2012 Dec;86(6):704-9. doi: 10.1016/j.contraception.2012.06.004. Epub 2012 Jul 6.'}]}, 'descriptionModule': {'briefSummary': 'Despite being the most common method of contraception, the use of intrauterine devices (IUDs) is limited by the associated pain during insertion. Many pharmacologic interventions had been studied for their efficacy to reduce IUD insertion pain, of them, lidocaine was found to be superior over NSAIDs or other local anesthetics. This work aims at comparing the safety and efficacy of different lidocaine formulations to optimize selection in reduction of IUD associated pain.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Multiparous women.\n2. Over 18 years of age and eligible for IUD insertion.\n3. Application of IUD will be done in postmenstrual period.\n\nExclusion Criteria:\n\nNull parity. 2. History of failed intrauterine device insertion (uterine perforation, acute expulsion).\n\n3\\. Copper allergy. 4. Uterine anomaly. 5. Post-partum endometritis or septic abortion in the past three months. 6. Untreated cervicitis/vaginitis, including bacterial vaginosis. 7. Immunosuppression. 8. History of lidocaine ,prilocaine allergy. 9. Analgesic or anxiolytic use within the last 24 hours before the procedure. 10. Wilson's disease. 11. Suspicion of pregnancy. 12. Untreated abnormal uterine bleeding."}, 'identificationModule': {'nctId': 'NCT03362905', 'briefTitle': 'Lidocaine for Pain Control During Intrauterine Device Insertion', 'organization': {'class': 'OTHER', 'fullName': 'Ain Shams University'}, 'officialTitle': 'Lidocaine for Pain Control During Intrauterine Device Insertion: A Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'Lidocaine in IUD pain'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Lidocaine spray Arm', 'description': 'This arm will receive lidocaine spray (Lidocaine topical aerosol ®, 10%, Arab drug co., Egypt) with dose four puffs (50 ml, 10 mg/puff) will be applied to the cervical canal and cervix.', 'interventionNames': ['Drug: Lidocaine topical']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Lidocaine cream Arm', 'description': 'This arm will receive topical cream (Pridocaine ®, Global Napi, Egypt) with a dose of 2g lidocaine cream will be applied to the cervix via cotton swab.', 'interventionNames': ['Drug: Lidocaine topical']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Lidocaine injection Arm', 'description': "This arm will receive lidocaine injection (Debocaine®, 2%, Sigma-Tec, Egypt) with a dose of 80-200 mg equivalent to 10 ml lidocaine (20 mg/ml) is injected at four and eight o'clock of the cervico-vaginal junction, and 2 ml to the area to be grasped with the tenaculum for paracervical block.", 'interventionNames': ['Drug: Lidocaine topical']}], 'interventions': [{'name': 'Lidocaine topical', 'type': 'DRUG', 'description': 'Local anesthetic for reduction of IUD associated pain', 'armGroupLabels': ['Lidocaine cream Arm', 'Lidocaine injection Arm', 'Lidocaine spray Arm']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Hadeer Elhagri, M.B.B.Ch', 'role': 'CONTACT', 'email': 'hadeer.elhagri@med.asu.edu.eg', 'phone': '01098357256'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ain Shams University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Resident physician', 'investigatorFullName': 'Hadeer Abd-El Shafy Fouad', 'investigatorAffiliation': 'Ain Shams University'}}}}