NCT00583011

Local Anesthesia and Pain Perception During an Amniocentesis

Local Anesthesia and Pain Perception During Amniocentesis: A Randomized Placebo-controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 76 (actual)
• Sponsor: University of Oklahoma · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Pregnancy

Interventions

Type	Name	Description
DRUG	Local Anesthesia	Local anesthesia: 2 cc of 1% Lidocaine
DRUG	Placebo Group	Placebo Group: 2cc Normal Saline

Timeline

• Start date: 2007-10-01
• Primary completion: 2011-05-01
• Completion: 2011-05-01
• First posted: 2007-12-28
• Last updated: 2021-02-03
• Results posted: 2021-02-03

Locations

1 site across 1 country: United States