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OpenTrials
Completed

NCT Number: NCT00811187

Paracervical Block During Office Hysteroscopy

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.

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Key information

Conditions

Paracervical Block

Age range

21 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Centennial Women's Center / Montefiore Medical Center

The Bronx, New York, 10467, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Planned secondary procedures
  • Lidocaine allergy
  • Repeat procedures

Treatment and study plan

Lidocaine paracervical block

Drug

5cc 1% lidocaine injection in each paracervical region

normal saline

Drug

5cc Normal Saline injection in each paracervical region

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Montefiore Medical Center

Other

Registry information

Official study title

Paracervical Block During Office Hysteroscopy: A Randomized Double Blind Placebo-controlled Trial

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Dec 18, 2008
Registry last updated
Dec 11, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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