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NCT Number: NCT00583011

Local Anesthesia and Pain Perception During an Amniocentesis

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.

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Key information

Conditions

Pregnancy Agnosia Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Local anesthesia

Drug

Local anesthesia: 2 cc of 1% Lidocaine

Other names: Amniocentesis

Placebo Group

Drug

Placebo Group: 2cc Normal Saline

Other names: Amniocentesis

Primary outcomes

  1. Intensity of Perceived Maternal Pain as Measured by the Visual Analogue Scale (VAS)

    Time frame: 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 outcomes

  1. Intensity of Perceived Maternal Pain as Measured by the 101 Point Numerical Rating Scale (NRS-101)

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

University of Oklahoma

Other

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2011
Study completion
2011
First posted
Dec 28, 2007
Registry last updated
Feb 3, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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