Paracervical Block During Office Hysteroscopy

Phase 2

Completed

• Conditions: Paracervical Block
• Interventions: Drug: Normal Saline; Drug: Lidocaine paracervical block

• Registration Number: NCT00811187
• Lead Sponsor: Montefiore Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-03
• Primary Completion: 2008-03
• Study Completion: 2008-09
• Study First Submitted: 2008-12-16
• Study First Submitted QC: 2008-12-17
• Study First Posted: 2008-12-18
• Results First Submitted: 2011-07-20
• Status Verified: 2019-12
• Results First Submitted QC: 2019-12-10
• Last Update Submitted: 2019-12-10
• Results First Posted: 2019-12-11
• Last Update Posted: 2019-12-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 80

Inclusion Criteria

• Women eligible and scheduled for office hysteroscopic placement of essure devices

Exclusion Criteria

• Planned secondary procedures
• Lidocaine allergy
• Repeat procedures

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Saline placebo injection	Normal Saline	5cc Normal Saline injection in each paracervical region
Lidocaine paracervical block	Lidocaine paracervical block	5cc 1% lidocaine injection in each paracervical region

Primary Outcome Measures

Name	Time	Method
Assessment of Pain on a 10-point Visual Analog Pain Scale During the Procedure.	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.

Trial Locations

Locations (1)

Centennial Women's Center / Montefiore Medical Center; 🇺🇸 Bronx, New York, United States