Expired Study
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Oklahoma City, Oklahoma 73104


Purpose:

This study is been designed to answer the question of whether local anesthesia (1% lidocaine) decreases the perception of pain associated with amniocentesis in a randomized double blind placebo controlled manner. Our objective is to determine the effect of local anesthesia on the maternal pain perception from an amniocentesis.


Study summary:

Women meeting criteria for project and agreeing to treatment will be randomized into either the 1% Lidocaine or placebo(normal saline) group. The initial injection of either 1% lidocaine or placebo (normal saline) will be administered 2 minutes prior to the amniocentesis procedure. 2cc of 1% lidocaine or placebo (normal saline) will be initially administered as an intradermal "wheal", followed by a deeper infiltration of the 1% lidocaine or placebo (normal saline) to the depth of the peritoneum. All procedures will be performed by either the Maternal-Fetal medicine (MFM) or the reproductive geneticist utilizing continuous ultrasound guidance under sterile conditions. Each woman will be asked to rate their pain perception immediately after the procedure on two pain scales.


Criteria:

Inclusion Criteria: - Singleton pregnancies - Signed consent to participate in the trial - Women between the ages of 18 and 45 years - Gestational ages 15 - 24 weeks Exclusion Criteria: - Multiple gestation - Refusal to participate in the trial - Known hypersensitivity to lidocaine - Amniocentesis during this pregnancy - Amnioinfusion/amnioreduction where the procedure is likely to be prolonged


NCT ID:

NCT00583011


Primary Contact:

Principal Investigator
Andrew Elimian, MD
University of Oklahoma


Backup Contact:

N/A


Location Contact:

Oklahoma City, Oklahoma 73104
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: March 16, 2018

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