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NCT Number: NCT03140293

Pain Perception During Chorionic Villus Sampling

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.

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Key information

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Early Phase 1

Primary location

Icahn School of Medicine at Mount Sinai

New York, 10029, United States

About this study

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.

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • <13 week gestation
  • Singleton gestations undergoing CVS

Exclusion criteria

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Visual Analog Scale (VAS) Pain perception scores VAS ()

    Time frame: day 1

    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

  2. Verbal Rating Scale (VRS)

    Time frame: day 1

    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

Sponsors and collaborators

Lead sponsor

Angela Bianco

Other

Registry information

Official study title

A Randomized Trial to Determine if Local Anesthesia Decreases Pain Perception in Women Undergoing Chorionic Villus Sampling

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
May 4, 2017
Registry last updated
Oct 25, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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