Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
EARLY_PHASE1
120 participants
INTERVENTIONAL
2016-09-30
2017-05-23
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
The 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.
This 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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Lidocaine Injection
Injection of lidocaine which is given prior to chorionic villus sampling
Lidocaine injection
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.
Gebauer Ethyl Chloride Spray
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.
Gebauer Ethyl Chloride Spray
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Lidocaine injection
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.
Gebauer Ethyl Chloride Spray
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Singleton gestations undergoing CVS
Exclusion Criteria
* More than one attempt of needle insertion
* Allergy or hypersensitivity to local anesthesia
18 Years
65 Years
FEMALE
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Angela Bianco
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Angela Bianco
MD
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Patricia Rekawek, M.D.
Role: PRINCIPAL_INVESTIGATOR
Icahn School of Medicine at Mount Sinai
Angela Bianco, M.D.
Role: STUDY_DIRECTOR
Ichan School of Medicine at Mount Sinai
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Icahn School of Medicine at Mount Sinai
New York, New York, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
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.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
GCO 14-1425
Identifier Type: -
Identifier Source: org_study_id