N/A
Completed N=76
Local Anesthesia and Pain Perception During an Amniocentesis
Source: ClinicalTrials.gov NCT00583011 ↗Enrolled (actual)
76
Serious AEs
0.0%
Results posted
Feb 2021
Primary outcomePrimary: Intensity of Perceived Maternal Pain as Measured by the Visual Analogue Scale (VAS) — 9.5; 18.4 units on a scale
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Intensity of Perceived Maternal Pain as Measured by the Visual Analogue Scale (VAS) |
9.5; 18.4 | — |
| SECONDARY Intensity of Perceived Maternal Pain as Measured by the 101 Point Numerical Rating Scale (NRS-101) |
15.4; 22.4 | <0.05 sig |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00583011). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.