Paracervical Block Clinical Trial
Official title:
Paracervical Block During Office Hysteroscopy: A Randomized Double Blind Placebo-controlled Trial
NCT number | NCT00811187 |
Other study ID # | 06-09-395 |
Secondary ID | |
Status | Completed |
Phase | Phase 2 |
First received | |
Last updated | |
Start date | March 2007 |
Est. completion date | September 2008 |
Verified date | December 2019 |
Source | Montefiore Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
United States | Centennial Women's Center / Montefiore Medical Center | Bronx | New York |
Lead Sponsor | Collaborator |
---|---|
Montefiore Medical Center |
United States,
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 |
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Completed |
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