Paracervical Block During Office Hysteroscopy

This study has been completed.
Sponsor:
Information provided by:
Montefiore Medical Center
ClinicalTrials.gov Identifier:
NCT00811187
First received: December 16, 2008
Last updated: December 17, 2008
Last verified: December 2008
  Purpose

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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: No ]

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

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders 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
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 ClinicalTrials.gov identifier: 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

No publications provided by Montefiore Medical Center

Additional 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
Study First Received: December 16, 2008
Last Updated: December 17, 2008
Health Authority: United States: Institutional Review Board

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
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Anti-Arrhythmia Agents
Cardiovascular Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on October 19, 2014