Paracervical Block During Office Hysteroscopy: A Randomized Double Blind Placebo-controlled Trial
Overview
- Phase
- Phase 2
- Intervention
- Lidocaine paracervical block
- Conditions
- Paracervical Block
- Sponsor
- Montefiore Medical Center
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- Assessment of Pain on a 10-point Visual Analog Pain Scale During the Procedure.
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Women eligible and scheduled for office hysteroscopic placement of essure devices
Exclusion Criteria
- •Planned secondary procedures
- •Lidocaine allergy
- •Repeat procedures
Arms & Interventions
Lidocaine paracervical block
5cc 1% lidocaine injection in each paracervical region
Intervention: Lidocaine paracervical block
Saline placebo injection
5cc Normal Saline injection in each paracervical region
Intervention: Normal Saline
Outcomes
Primary Outcomes
Assessment of Pain on a 10-point Visual Analog Pain Scale During the Procedure.
Time Frame: During Procedure
This used a visual analog scale from 0 (minimum) to 10 (maximum) that was measured as centimeters. A higher score would indicate more pain, therefore, a worse outcome. Pain was assessed at each step that could potentially elicit pain, specifically when there was direct physical manipulation.