N/A N=76 Randomized Triple-blind Diagnostic

Local Anesthesia and Pain Perception During an Amniocentesis

Pregnancy

Bottom Line

View on ClinicalTrials.gov: NCT00583011 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Feb 2021

Primary outcome: Primary: Intensity of Perceived Maternal Pain as Measured by the Visual Analogue Scale (VAS) — 9.5; 18.4 units on a scale

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Local Anesthesia (Drug); Placebo Group (Drug)
Age: Adult · 18+ yrs
Sex: Female
Sponsor: University of Oklahoma
Primary completion: May 2011

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

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.

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

View full record on ClinicalTrials.gov →

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.