Pain Perception During Chorionic Villus Sampling

NCT03140293 | Completed Early Phase 1 FDA Drug

• 1 other identifier: GCO 14-1425
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chorionic Villi Sampling

Keywords

Chorionic villus sampling; Pain; Anxiety

Outcome Measures

Primary Outcomes (2)

• Visual Analog Scale (VAS) Pain perception scores VAS ()

  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

  day 1

• Verbal Rating Scale (VRS)

  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

  day 1

Study Arms (2)

Lidocaine Injection

ACTIVE COMPARATOR

Injection of lidocaine which is given prior to chorionic villus sampling

Drug: Lidocaine injection

Gebauer Ethyl Chloride Spray

EXPERIMENTAL

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.

Drug: Gebauer Ethyl Chloride Spray

Interventions

Lidocaine injection DRUG

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.

Lidocaine Injection

Gebauer Ethyl Chloride Spray DRUG

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.

Gebauer Ethyl Chloride Spray

Eligibility Criteria

• Age: 18 Years - 65 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \<13 week gestation
• Singleton gestations undergoing CVS

You may not qualify if:

• Multiple gestations
• More than one attempt of needle insertion
• Allergy or hypersensitivity to local anesthesia

Sponsors & Collaborators

• Angela Bianco: lead

Study Sites (1)

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

Related Publications (6)

• 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: 8604867 BACKGROUND

• 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: 16378331 BACKGROUND

• 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: 22071854 BACKGROUND

• 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: 17240233 BACKGROUND

• 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: 11169347 BACKGROUND

• 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.

  PMID: 30983457 DERIVED

MeSH Terms

Conditions

Pain; Anxiety Disorders

Interventions

Lidocaine

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Patricia Rekawek, M.D.

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

• Angela Bianco, M.D.

  Ichan School of Medicine at Mount Sinai

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: March 28, 2017
• First Posted: May 4, 2017
• Study Start: September 1, 2016
• Primary Completion: May 23, 2017
• Study Completion: May 23, 2017
• Last Updated: October 25, 2017

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)