Ignite Creation Date:
2025-12-25 @ 1:01 AM
Ignite Modification Date:
2026-03-04 @ 8:13 PM
Study NCT ID:
NCT03140293
Status:
COMPLETED
Last Update Posted:
2017-10-25
First Post:
2017-03-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pain Perception During Chorionic Villus Sampling
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, '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': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-10', 'completionDateStruct': {'date': '2017-05-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-10-23', 'studyFirstSubmitDate': '2017-03-28', 'studyFirstSubmitQcDate': '2017-05-02', 'lastUpdatePostDateStruct': {'date': '2017-10-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-05-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-05-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Visual Analog Scale (VAS) Pain perception scores VAS ()', 'timeFrame': 'day 1', 'description': 'Procedure pain perception score as measured by the visual analog scale. By means of analysis of the receiver operating characteristic curves on a 100mm VAS: no pain 0-2 mm, mild pain 2-17 mm, moderate pain 17-47 mm, severe pain 47-77 mm, very severe pain 77-96 mm, most severe pain imaginable 96-100 mm'}, {'measure': 'Verbal Rating Scale (VRS)', 'timeFrame': 'day 1', 'description': 'Procedure pain perception score as measured by the Verbal Rating Scale. 0=no pain, 1=mild pain, 2=moderate pain, 3=severe pain, 4=very severe pain, 5=most severe pain imaginable'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Chorionic villus sampling', 'Pain', 'Anxiety'], 'conditions': ['Chorionic Villi Sampling']}, 'referencesModule': {'references': [{'pmid': '8604867', 'type': 'BACKGROUND', 'citation': 'Todd KH, Funk KG, Funk JP, Bonacci R. Clinical significance of reported changes in pain severity. Ann Emerg Med. 1996 Apr;27(4):485-9. doi: 10.1016/s0196-0644(96)70238-x.'}, {'pmid': '16378331', 'type': 'BACKGROUND', 'citation': 'Csaba A, Bush MC, Saphier C. How painful are amniocentesis and chorionic villus sampling? Prenat Diagn. 2006 Jan;26(1):35-8. doi: 10.1002/pd.1323.'}, {'pmid': '22071854', 'type': 'BACKGROUND', 'citation': 'Mujezinovic F, Alfirevic Z. Analgesia for amniocentesis or chorionic villus sampling. Cochrane Database Syst Rev. 2011 Nov 9;2011(11):CD008580. doi: 10.1002/14651858.CD008580.pub2.'}, {'pmid': '17240233', 'type': 'BACKGROUND', 'citation': 'Gordon MC, Ventura-Braswell A, Higby K, Ward JA. Does local anesthesia decrease pain perception in women undergoing amniocentesis? Am J Obstet Gynecol. 2007 Jan;196(1):55.e1-4. doi: 10.1016/j.ajog.2006.08.025.'}, {'pmid': '11169347', 'type': 'BACKGROUND', 'citation': 'Van Schoubroeck D, Verhaeghe J. Does local anesthesia at mid-trimester amniocentesis decrease pain experience? A randomized trial in 220 patients. Ultrasound Obstet Gynecol. 2000 Nov;16(6):536-8. doi: 10.1046/j.1469-0705.2000.00240.x.'}, {'pmid': '30983457', 'type': 'DERIVED', 'citation': 'Rekawek P, Stone JL, Robles B, Connolly KA, Bigelow CA, Tudela F, Bianco AT. Pain perception during transabdominal chorionic villus sampling: a randomized trial comparing topical ethyl chloride anesthetic spray and lidocaine injection. J Matern Fetal Neonatal Med. 2021 Feb;34(3):339-345. doi: 10.1080/14767058.2019.1607288. Epub 2019 Apr 25.'}]}, 'descriptionModule': {'briefSummary': 'Chorionic villous sampling is a frequent procedure used for antenatal genetic testing. This procedure is associated with anxiety and fear of pain that can be expected during the procedure, often prejudicing patients against this definitive antenatal testing. It is important to determine if different approaches to pain and anxiety reduction are effective. Currently there is no randomized study to evaluate the efficacy of analgesia for pain reduction during chorionic villous sampling. Multiple studies have been published suggesting that analgesia during the similar procedure of amniocentesis does not significantly reduce pain scores.', 'detailedDescription': 'Chorionic villous sampling (CVS) is a frequent procedure used for antenatal genetic testing. This procedure is associated with anxiety and fear of pain that can be expected during the procedure, often prejudicing patients against this definitive antenatal testing. It is important to determine if different approaches to pain and anxiety reduction are effective. Previous studies have not shown that local anesthesia affects pain experience during amniocentesis (1-5). There are no randomized studies evaluating interventions for pain reduction during chorionic villous sampling which constitutes an important evidence gap.\n\nThe study will be offered to women at \\<13 weeks gestation, with a singleton fetus who are seen at Mount Sinai Medical Center for chorionic villous sampling. The eligible women will be randomized to one of two groups: use of analgesia using injectable lidocaine or ethyl chloride topical anesthetic spray. This study intends to show that local anesthesia during chorionic villous sampling will not decrease the perception of pain in patients undergoing this procedure.\n\nThis trial is trying to determine perception of pain based on use of injectable lidocaine or ethyl chloride anesthetic spray; it is noted that the form of anesthesia may be a factor in perception of pain. The investigators do not know if there is a difference in perception for topical or injectable. If the perceived pain is comparable in topical and injectable, this trial could conclude that both are viable options, and while both present minimal risk to patients, topical is less invasive.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'genderBased': True, 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* \\<13 week gestation\n* Singleton gestations undergoing CVS\n\nExclusion Criteria:\n\n* Multiple gestations\n* More than one attempt of needle insertion\n* Allergy or hypersensitivity to local anesthesia'}, 'identificationModule': {'nctId': 'NCT03140293', 'briefTitle': 'Pain Perception During Chorionic Villus Sampling', 'organization': {'class': 'OTHER', 'fullName': 'Icahn School of Medicine at Mount Sinai'}, 'officialTitle': 'A Randomized Trial to Determine if Local Anesthesia Decreases Pain Perception in Women Undergoing Chorionic Villus Sampling', 'orgStudyIdInfo': {'id': 'GCO 14-1425'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Lidocaine Injection', 'description': 'Injection of lidocaine which is given prior to chorionic villus sampling', 'interventionNames': ['Drug: Lidocaine injection']}, {'type': 'EXPERIMENTAL', 'label': 'Gebauer Ethyl Chloride Spray', 'description': 'Topical anesthesia will be Gebauer Ethyl Chloride sprayed continuously from 3 - 7 seconds from a distance of 3-9 inches until the skin turns white (not frosting the skin) as per Gebauer package insert instructions.', 'interventionNames': ['Drug: Gebauer Ethyl Chloride Spray']}], 'interventions': [{'name': 'Lidocaine injection', 'type': 'DRUG', 'description': 'Injectable anesthesia is 1-2mL of 2% lidocaine via a 22 gage needle, given at the anticipated site of CVS needle puncture immediately before procedure.', 'armGroupLabels': ['Lidocaine Injection']}, {'name': 'Gebauer Ethyl Chloride Spray', 'type': 'DRUG', 'description': 'Gebauer Ethyl Chloride Spray is a topical anesthetic spray which is sprayed continuously for 3-7 seconds from a distance of 3-9 inches at the site where the chorionic villus sampling is expected to take place.', 'armGroupLabels': ['Gebauer Ethyl Chloride Spray']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10029', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Icahn School of Medicine at Mount Sinai', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Patricia Rekawek, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Icahn School of Medicine at Mount Sinai'}, {'name': 'Angela Bianco, M.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Ichan School of Medicine at Mount Sinai'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Angela Bianco', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Angela Bianco', 'investigatorAffiliation': 'Icahn School of Medicine at Mount Sinai'}}}}