Paracervical Block During Office Hysteroscopy

Paracervical Block Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00811187
• Other study ID #: 06-09-395
• Status: Completed
• Phase: Phase 2
• Start date: March 2007
• Est. completion date: September 2008

Study information

• Verified date: December 2019
• Source: Montefiore Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: September 2008
• Est. primary completion date: March 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 21 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Planned secondary procedures

• Lidocaine allergy

• Repeat procedures

Related Conditions & MeSH terms

• Paracervical Block

Intervention

Drug:
• Lidocaine paracervical block
5cc 1% lidocaine injection in each paracervical region
• Normal Saline
5cc Normal Saline injection in each paracervical region

Locations

Country	Name	City	State
United States	Centennial Women's Center / Montefiore Medical Center	Bronx	New York

Sponsors (1)

Lead Sponsor	Collaborator
Montefiore Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	During Procedure