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Local Anesthesia and Pain Perception During an Amniocentesis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Oklahoma
ClinicalTrials.gov Identifier:
NCT00583011
First received: December 19, 2007
Last updated: June 12, 2012
Last verified: June 2012
History of Changes
  Purpose

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 Intervention
Pregnancy
 Drug: Local anesthesia - lidocaine
Drug: Placebo Group

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Diagnostic
Official Title: Local Anesthesia and Pain Perception During Amniocentesis: A Randomized Placebo-controlled Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Oklahoma:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 70
Study Start Date: October 2007
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00583011

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

No publications provided

Responsible Party: University of Oklahoma
ClinicalTrials.gov Identifier: NCT00583011     History of Changes
Other Study ID Numbers: AmniocentesisPain
Study First Received: December 19, 2007
Last Updated: June 12, 2012
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Anesthetics
Lidocaine
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
 Therapeutic Uses
Anesthetics, Local
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Cardiovascular Agents

ClinicalTrials.gov processed this record on June 18, 2013