Local Anesthesia and Pain Perception During an Amniocentesis

Pregnancy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00583011
• Other study ID #: AmniocentesisPain
• Status: Completed
• Phase: N/A
• Start date: October 2007
• Est. completion date: May 2011

Study information

• Verified date: January 2021
• Source: University of Oklahoma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: May 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Pregnancy

Intervention

Drug:
• Local Anesthesia
Local anesthesia: 2 cc of 1% Lidocaine
• Placebo Group
Placebo Group: 2cc Normal Saline

Locations

Country	Name	City	State
United States	University of Oklahoma Health Sciences Center	Oklahoma City	Oklahoma

Sponsors (1)

Lead Sponsor	Collaborator
University of Oklahoma

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intensity of Perceived Maternal Pain as Measured by the Visual Analogue Scale (VAS)	Visual Analogue Scale (Perpendicular line is drawn at the point that represents pain on a 0-100mm scale, with lower number meaning less pain and the higher number meaning more pain)	Immediately following amniocentesis procedure
Secondary	Intensity of Perceived Maternal Pain as Measured by the 101 Point Numerical Rating Scale (NRS-101)	101 Point Numerical Rating Scale (NRS-101) (Choose a number that best described pain from 0 to 100 with 0 being least amount of pain and 100 being the worst pain)	Immediately following amniocentesis procedure