Phase 4
N=96
12 Versus 20 mL PCB for D&E Cervical Prep
Pain
Bottom Line
View on ClinicalTrials.gov: NCT03356145 ↗Enrolled (actual)
96
Serious AEs
0.0%
Results posted
Oct 2021
Primary outcome: Primary: Pain Immediately Following Dilator Insertion — 41; 49 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- 12 mL paracervical block (Drug); 20 mL paracervical block (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Stanford University
- Primary completion
- Oct 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pain Immediately Following Dilator Insertion |
41; 49 | — |
| SECONDARY Anticipated Pain Immediately Prior to Dilator Insertion |
51; 58 | — |
| SECONDARY Patient Global Satisfaction Score |
70; 53 | — |
| SECONDARY Total Procedure Time |
5.5; 5.7 | — |
| SECONDARY Physician-reported Ease of Insertion |
27; 17 | — |
| SECONDARY Count of Participants With Procedural Complications |
0; 0 | — |
| SECONDARY Count of Participants With Side Effects Related to Lidocaine Administration |
2; 3; 2; 3; 1; 6 | — |
Summary
More research is needed to investigate methods of pain control for cervical preparation for abortion procedures. Women report pain with paracervical block injection as well as with osmotic dilator placement. This study seeks to compare a 12 mL, 2-site 1% plain lidocaine paracervical block for pain control during cervical preparation (osmotic dilator insertion) for Dilation and Evacuation (D&E) to a 20 mL 1% lidocaine 2-site 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 (NCT03356145). 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.