Phase 2
N=80
Paracervical Block During Office Hysteroscopy
Paracervical Block
Bottom Line
View on ClinicalTrials.gov: NCT00811187 ↗Enrolled (actual)
80
Serious AEs
0.0%
Results posted
Dec 2019
Primary outcome: Primary: Assessment of Pain on a 10-point Visual Analog Pain Scale During the Procedure. — 4.15; 3.38 Score on a scale — p=<.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Lidocaine paracervical block (Drug); Normal Saline (Drug)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- Female
- Sponsor
- Montefiore Medical Center
- Primary completion
- Mar 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Assessment of Pain on a 10-point Visual Analog Pain Scale During the Procedure. |
4.15; 3.38 | <.001 sig |
Summary
The purpose of this study is to determine the effectiveness of paracervical block for pain relief in office hysteroscopy - particularly with the placement of the Essure device. Subjects will be randomized to receive either paracervical block or saline, and will have pain assessments performed throughout the procedure. Subjects and physicians will be blinded to group assignments.
Eligibility Criteria
Inclusion Criteria
- Women eligible and scheduled for office hysteroscopic placement of essure devices
Exclusion Criteria
- Planned secondary procedures
- Lidocaine allergy
- Repeat procedures
Data sourced from ClinicalTrials.gov (NCT00811187). 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.