Phase 3
N=72
Self-administered Lidocaine Gel for Pain-control During Cervical Preparation for Dilation and Evacuation
Pain Management, Cervical Preparation
Bottom Line
View on ClinicalTrials.gov: NCT02852434 ↗Enrolled (actual)
72
Serious AEs
0.0%
Results posted
Apr 2018
Primary outcome: Primary: Pain Perceived at the Time of Laminaria or Osmotic Dilator Insertion — 48.4; 56.3 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Lidocaine Gel (2%) (Drug); Lidocaine Paracervical Block (1%) (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Stanford University
- Primary completion
- Apr 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pain Perceived at the Time of Laminaria or Osmotic Dilator Insertion |
48.4; 56.3 | — |
| SECONDARY Anticipated Pain Measured by Visual Analogue Scale |
47.2; 58.7 | — |
| SECONDARY Baseline Pain Measured by Visual Analogue Scale |
2.6; 6.6 | — |
| SECONDARY Speculum Placement Measured by Visual Analogue Scale |
24.7; 31.2 | — |
| SECONDARY Overall Pain Measured by Visual Analogue Scale |
45.4; 51.7; 65.2; 62.4; 27; 21 | — |
Summary
This study seeks to compare self-administered lidocaine gel for pain control during cervical preparation for dilation and evacuation (D&E) to paracervical block.
Eligibility Criteria
Inclusion Criteria
- Women 18 and older
- Intrauterine pregnancy ≥16 weeks gestation
- English speaking competency
- Willing and able to sign consent forms
- Agree to comply with study procedures
Exclusion Criteria
- Women less than 18 years of age
- IV conscious sedation
- Known allergy to study medication (lidocaine)
- Any women not meeting inclusion criteria above will be excluded from participation
Data sourced from ClinicalTrials.gov (NCT02852434). 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.