Local Anesthesia and Pain Perception During an Amniocentesis

Not Applicable

Completed

• Conditions: Pregnancy
• Interventions: Drug: Local Anesthesia; Drug: Placebo Group

• Registration Number: NCT00583011
• Lead Sponsor: University of Oklahoma

Brief 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.

Study Timeline

• Study Start: 2007-10
• Study First Submitted: 2007-12-19
• Study First Submitted QC: 2007-12-27
• Study First Posted: 2007-12-28
• Primary Completion: 2011-05
• Study Completion: 2011-05
• Results First Submitted: 2020-10-15
• Status Verified: 2021-01
• Results First Submitted QC: 2021-01-14
• Last Update Submitted: 2021-01-14
• Results First Posted: 2021-02-03
• Last Update Posted: 2021-02-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 76

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Local Anesthesia	Local Anesthesia	Local anesthesia group. 2cc of 1% lidocaine with epinephrine administered 2 minutes before amniocentesis, using a 21 gauge needle initially as an intradermal wheal followed by a deeper infiltration of 2cc of 1% lidocaine to the depth of the peritoneum.
Placebo-Normal saline	Placebo Group	Placebo normal saline group. 2cc of normal saline epinephrine administered 2 minutes before amniocentesis, using a 21 gauge needle initially as an intradermal wheal followed by a deeper infiltration of 2cc of normal saline to the depth of the peritoneum.

Primary Outcome Measures

Name	Time	Method
Intensity of Perceived Maternal Pain as Measured by the Visual Analogue Scale (VAS)	Immediately following amniocentesis procedure	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)

Secondary Outcome Measures

Name	Time	Method
Intensity of Perceived Maternal Pain as Measured by the 101 Point Numerical Rating Scale (NRS-101)	Immediately following amniocentesis procedure	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)

Trial Locations

Locations (1)

University of Oklahoma Health Sciences Center; 🇺🇸 Oklahoma City, Oklahoma, United States