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Paracervical Block During Office Hysteroscopy

This study has been completed.
Information provided by:
Montefiore Medical Center Identifier:
First received: December 16, 2008
Last updated: December 17, 2008
Last verified: December 2008
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 Intervention
Paracervical Block Drug: Lidocaine paracervical block Drug: Normal Saline

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Paracervical Block During Office Hysteroscopy: A Randomized Double Blind Placebo-Controlled Trial

Resource links provided by NLM:

Further study details as provided by Montefiore Medical Center:

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

Enrollment: 80
Study Start Date: March 2007
Study Completion Date: September 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00811187

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

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Scott Chudnoff, MD, Montefiore Medical Center Identifier: NCT00811187     History of Changes
Other Study ID Numbers: 06-09-395
Study First Received: December 16, 2008
Last Updated: December 17, 2008

Keywords provided by Montefiore Medical Center:
Pain medication
Office Procedures

Additional relevant MeSH terms:
Anesthetics, Local
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 processed this record on June 22, 2017