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Local Anesthesia and Pain Perception During an Amniocentesis

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ClinicalTrials.gov Identifier: NCT00583011
Recruitment Status : Completed
First Posted : December 28, 2007
Last Update Posted : April 12, 2017
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Pregnancy Drug: Local anesthesia - lidocaine Drug: Placebo Group

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Diagnostic
Official Title: Local Anesthesia and Pain Perception During Amniocentesis: A Randomized Placebo-controlled Trial
Study Start Date : October 2007
Primary Completion Date : May 2011
Study Completion Date : May 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anesthesia
Drug Information available for: Lidocaine
U.S. FDA Resources

Arm Intervention/treatment
Experimental: A
Local anesthesia group
Drug: Local anesthesia - lidocaine
Local anesthesia: 2 cc of 1% Lidocaine
Placebo Comparator: B
Placebo normal saline group
Drug: Placebo Group
Placebo Group: 2cc Normal Saline

Primary Outcome Measures :
  1. Intensity of perceived maternal pain as measured by a the two pain scales: 101 point Numerical Rating Scale (NRS-101) as well as the Visual Analogue Scale (VAS) [ Time Frame: 2 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00583011

United States, Oklahoma
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States, 73104
Sponsors and Collaborators
University of Oklahoma
Principal Investigator: Andrew Elimian, MD University of Oklahoma

Responsible Party: University of Oklahoma
ClinicalTrials.gov Identifier: NCT00583011     History of Changes
Other Study ID Numbers: AmniocentesisPain
First Posted: December 28, 2007    Key Record Dates
Last Update Posted: April 12, 2017
Last Verified: April 2017

Keywords provided by University of Oklahoma:
Genetic amniocentesis
Fetal lung maturity
Pain control
High risk pregnancy

Additional relevant MeSH terms:
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Local
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action