Paracervical Block During Office Hysteroscopy

Montefiore Medical Center80 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Paracervical Block

Interventions

Lidocaine paracervical blockDRUG

5cc 1% lidocaine injection in each paracervical region

Normal SalineDRUG

5cc Normal Saline injection in each paracervical region

Eligibility

Sex: FEMALEMin age: 21 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Women eligible and scheduled for office hysteroscopic placement of essure devices Exclusion Criteria: * Planned secondary procedures * Lidocaine allergy * Repeat procedures

Locations (1)

Centennial Women's Center / Montefiore Medical Center

The Bronx, New York, United States

Outcomes

Primary Outcomes

Assessment of Pain on a 10-point Visual Analog Pain Scale During the 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.

Time frame: During Procedure

Data from ClinicalTrials.gov

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