CI

At a glance

ClinicalIndex Comparison Record
Early Ph 1Completed· 120 enrolled
Drug / intervention
Lidocaine injection +1 moredrug
Likely dose
Lidocaine injection 2mLfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03140293
NCT03140293Early Ph 1Completed

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

Angela Bianco·interventional·Posted May 4, 2017·Updated Oct 25, 2017

In Brief

A Early Phase 1 clinical trial evaluating Lidocaine injection and Gebauer Ethyl Chloride Spray for Chorionic Villi Sampling. Completed, enrolled 120 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Early Ph 1CompletedFinished
2017201820192020202120222023202420252026
First PostedMay 4, 2017
Enrollment StartSep 1, 2016
Primary CompletionMay 23, 2017
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 9.2 years ago

Interventions

Lidocaine injectiondrug

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 Spraydrug

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.