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| Sponsored by: |
University of Oklahoma |
|---|---|
| Information provided by: | University of Oklahoma |
| ClinicalTrials.gov Identifier: | NCT00583011 |
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: | Diagnostic, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Efficacy Study |
| Official Title: | Local Anesthesia and Pain Perception During Amniocentesis: A Randomized Placebo-Controlled Trial |
| Estimated Enrollment: | 200 |
| Study Start Date: | October 2007 |
| Estimated Study Completion Date: | October 2009 |
| Estimated Primary Completion Date: | October 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
A: Experimental
Local anesthesia group
|
Drug: Local anesthesia - lidocaine
Local anesthesia: 2 cc of 1% Lidocaine
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B: Placebo Comparator
Placebo normal saline group
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Drug: Placebo Group
Placebo Group: 2cc Normal Saline
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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.
Eligibility| Ages Eligible for Study: | 18 Years to 45 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Shelly Hooper, RN | 405-271-8001 ext 48197 | |
| Contact: Christy Zornes, MHR | 405-271-8001 ext 48137 | christina-zornes@ouhsc.edu |
| United States, Oklahoma | |
| University of Oklahoma Health Sciences Center | Recruiting |
| Oklahoma City, Oklahoma, United States, 73104 | |
| Principal Investigator: | Andrew Elimian, MD | University of Oklahoma |
More Information
| Responsible Party: | University of Oklahoma Health Sciences Center ( Andrew Elimian, MD ) |
| Study ID Numbers: | AmniocentesisPain |
| Study First Received: | December 19, 2007 |
| Last Updated: | December 11, 2008 |
| ClinicalTrials.gov Identifier: | NCT00583011 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
Amniocentesis Genetic amniocentesis Fetal lung maturity |
Pain control Pregnancy High risk pregnancy |
|
Lidocaine Central Nervous System Depressants Anesthetics Pain |
Cardiovascular Agents Anti-Arrhythmia Agents Peripheral Nervous System Agents Anesthetics, Local |
|
Sensory System Agents Therapeutic Uses Physiological Effects of Drugs Lidocaine Central Nervous System Depressants Anesthetics |
Cardiovascular Agents Anti-Arrhythmia Agents Peripheral Nervous System Agents Central Nervous System Agents Anesthetics, Local Pharmacologic Actions |
