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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Local Anesthesia | Experimental | Local anesthesia group. 2cc of 1% lidocaine with epinephrine administered 2 minutes before amniocentesis, using a 21 gauge needle initially as an intradermal wheal followed by a deeper infiltration of 2cc of 1% lidocaine to the depth of the peritoneum. |
|
| Placebo-Normal saline | Placebo Comparator | Placebo normal saline group. 2cc of normal saline epinephrine administered 2 minutes before amniocentesis, using a 21 gauge needle initially as an intradermal wheal followed by a deeper infiltration of 2cc of normal saline to the depth of the peritoneum. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Local Anesthesia | Drug | Local anesthesia: 2 cc of 1% Lidocaine |
|
| Measure | Description | Time Frame |
|---|---|---|
| Intensity of Perceived Maternal Pain as Measured by the Visual Analogue Scale (VAS) | 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) | Immediately following amniocentesis procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Intensity of Perceived Maternal Pain as Measured by the 101 Point Numerical Rating Scale (NRS-101) | 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) | Immediately following amniocentesis procedure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andrew Elimian, MD | University of Oklahoma | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Oklahoma Health Sciences Center | Oklahoma City | Oklahoma | 73104 | United States |
Assessed for eligibility (n=203) Excluded=127(26 not meeting inclusion criteria, 101 declined to participate)
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| ID | Title | Description |
|---|---|---|
| FG000 | Lidocaine | Local anesthesia group Local anesthesia - lidocaine: Local anesthesia: 2 cc of 1% Lidocaine |
| FG001 | Placebo | Placebo normal saline group Placebo Group: Placebo Group: 2cc Normal Saline |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Lidocaine | Lidocaine group 2cc of 1% lidocaine |
| BG001 | Placebo | Normal saline group 2cc of normal saline |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Intensity of Perceived Maternal Pain as Measured by the Visual Analogue Scale (VAS) | 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) | Posted | Median | Inter-Quartile Range | units on a scale | Immediately following amniocentesis procedure |
|
6 months
No adverse events
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Lidocaine | Lidocaine 2cc of 1% lidocaine group | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Andrew Elimian, MD | University of Oklahoma Health Science Center | 9142317323 | aelimian@aol.com |
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| ID | Term |
|---|---|
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D000772 | Anesthesia, Local |
| D000649 | Amniocentesis |
| ID | Term |
|---|---|
| D000765 | Anesthesia, Conduction |
| D000758 | Anesthesia |
| D000760 | Anesthesia and Analgesia |
| D003581 | Cytodiagnosis |
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| Placebo Group | Drug | Placebo Group: 2cc Normal Saline |
|
|
| BG002 |
| Total |
Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| Secondary | Intensity of Perceived Maternal Pain as Measured by the 101 Point Numerical Rating Scale (NRS-101) | 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) | Posted | Mean | Standard Deviation | units on a scale | Immediately following amniocentesis procedure |
|
|
|
|
| 36 |
| 0 |
| 36 |
| 0 |
| 36 |
| EG001 | Placebo | 2cc of Normal saline group | 0 | 40 | 0 | 40 | 0 | 40 |
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| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003584 |
| Cytological Techniques |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D019152 | Paracentesis |
| D013048 | Specimen Handling |
| D011296 | Prenatal Diagnosis |
| D003944 | Diagnostic Techniques, Obstetrical and Gynecological |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |