Pregnancy
Conditions
Keywords
Amniocentesis, Genetic amniocentesis, Fetal lung maturity, Pain control, Pregnancy, High risk pregnancy
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.
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.
Interventions
DRUGLocal Anesthesia
Local anesthesia: 2 cc of 1% Lidocaine
DRUGPlacebo Group
Placebo Group: 2cc Normal Saline
Sponsors
University of Oklahoma
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intensity of Perceived Maternal Pain as Measured by the Visual Analogue Scale (VAS) | Immediately following amniocentesis procedure | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Intensity of Perceived Maternal Pain as Measured by the 101 Point Numerical Rating Scale (NRS-101) | Immediately following amniocentesis procedure | 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) |
Countries
United States
Participant flow
Pre-assignment details
Assessed for eligibility (n=203) Excluded=127(26 not meeting inclusion criteria, 101 declined to participate)
Participants by arm
| Arm | Count |
|---|---|
| Lidocaine Lidocaine group 2cc of 1% lidocaine | 36 |
| Placebo Normal saline group 2cc of normal saline | 40 |
| Total | 76 |
Baseline characteristics
| Characteristic | Placebo | Lidocaine | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 40 Participants | 36 Participants | 76 Participants |
| Age, Continuous | 30.1 years STANDARD_DEVIATION 7.5 | 31.3 years STANDARD_DEVIATION 6.5 | 30.7 years STANDARD_DEVIATION 7 |
| Region of Enrollment United States | 40 Participants | 36 Participants | 76 Participants |
| Sex: Female, Male Female | 40 Participants | 36 Participants | 76 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 36 | 0 / 40 |
| other Total, other adverse events | 0 / 36 | 0 / 40 |
| serious Total, serious adverse events | 0 / 36 | 0 / 40 |
Outcome results
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)
Time frame: Immediately following amniocentesis procedure
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Lidocaine | Intensity of Perceived Maternal Pain as Measured by the Visual Analogue Scale (VAS) | 9.5 units on a scale |
| Placebo | Intensity of Perceived Maternal Pain as Measured by the Visual Analogue Scale (VAS) | 18.4 units on a scale |
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)
Time frame: Immediately following amniocentesis procedure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lidocaine | Intensity of Perceived Maternal Pain as Measured by the 101 Point Numerical Rating Scale (NRS-101) | 15.4 units on a scale | Standard Deviation 13.5 |
| Placebo | Intensity of Perceived Maternal Pain as Measured by the 101 Point Numerical Rating Scale (NRS-101) | 22.4 units on a scale | Standard Deviation 19.8 |
p-value: <0.05Wilcoxon (Mann-Whitney)