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

December 19, 2007
June 12, 2012
October 2007
May 2011   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00583011 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Local Anesthesia and Pain Perception During an Amniocentesis
Local Anesthesia and Pain Perception During Amniocentesis: A Randomized Placebo-controlled Trial

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Diagnostic
Pregnancy
  • Drug: Local anesthesia - lidocaine
    Local anesthesia: 2 cc of 1% Lidocaine
  • Drug: Placebo Group
    Placebo Group: 2cc Normal Saline
  • Experimental: A
    Local anesthesia group
    Intervention: Drug: Local anesthesia - lidocaine
  • Placebo Comparator: B
    Placebo normal saline group
    Intervention: Drug: Placebo Group
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
70
May 2011
May 2011   (final data collection date for primary outcome measure)

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
Female
18 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00583011
AmniocentesisPain
No
University of Oklahoma
University of Oklahoma
Not Provided
Principal Investigator: Andrew Elimian, MD University of Oklahoma
University of Oklahoma
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP