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Pain Perception During Chorionic Villus Sampling

NCT03140293 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2017-10-25

No results posted yet for this study

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

Interventions

DRUG

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.

DRUG

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.

Sponsors & Collaborators

  • Angela Bianco

    lead OTHER

Principal Investigators

  • Patricia Rekawek, M.D. · Icahn School of Medicine at Mount Sinai

  • Angela Bianco, M.D. · Ichan School of Medicine at Mount Sinai

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-09-30
Primary Completion
2017-05-23
Completion
2017-05-23
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03140293 on ClinicalTrials.gov