Local Anesthesia and Pain Perception During an Amniocentesis

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Pregnancy

Intervention / Treatment
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* Drug: Local Anesthesia
* Drug: Placebo Group


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Local Anesthesia<br>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. | Drug: Local Anesthesia<br>* Local anesthesia: 2 cc of 1% Lidocaine<br>* Other names: Amniocentesis;|
| Placebo Comparator: Placebo-Normal saline<br>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. | Drug: Placebo Group<br>* Placebo Group: 2cc Normal Saline<br>* Other names: Amniocentesis;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Amniocentesis, Genetic amniocentesis, Fetal lung maturity, Pain control, Pregnancy, High risk pregnancy