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Paracervical Block During Office Hysteroscopy

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ClinicalTrials.gov Identifier: NCT00811187
Recruitment Status : Completed
First Posted : December 18, 2008
Last Update Posted : December 18, 2008
Sponsor:
Information provided by:

Study Description
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.

Condition or disease Intervention/treatment
Paracervical Block Drug: Lidocaine paracervical block Drug: Normal Saline

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Paracervical Block During Office Hysteroscopy: A Randomized Double Blind Placebo-Controlled Trial
Study Start Date : March 2007
Primary Completion Date : March 2008
Study Completion Date : September 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: 1
Lidocaine paracervical block
Drug: Lidocaine paracervical block
5cc 1% lidocaine injection in each paracervical region
Placebo Comparator: 2
Saline placebo injection
Drug: Normal Saline
5cc Normal Saline injection in each paracervical region


Outcome Measures

Primary Outcome Measures :
  1. Pain Score [ Time Frame: During Procedure ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Planned secondary procedures
  • Lidocaine allergy
  • Repeat procedures
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00811187


Locations
United States, New York
Centennial Women's Center / Montefiore Medical Center
Bronx, New York, United States, 10467
Sponsors and Collaborators
Montefiore Medical Center
Investigators
Principal Investigator: Scott Chudnoff, MD Montefiore Medical Center / Albert Einstein College of Medicine
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Scott Chudnoff, MD, Montefiore Medical Center
ClinicalTrials.gov Identifier: NCT00811187     History of Changes
Other Study ID Numbers: 06-09-395
First Posted: December 18, 2008    Key Record Dates
Last Update Posted: December 18, 2008
Last Verified: December 2008

Keywords provided by Montefiore Medical Center:
Hysteroscopy
Pain medication
Lidocaine
Office Procedures

Additional relevant MeSH terms:
Lidocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action