Paracervical Block During Office Hysteroscopy - Full Text View

Sponsored by:	Montefiore Medical Center
Information provided by:	Montefiore Medical Center
ClinicalTrials.gov Identifier:	NCT00811187

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

Drug Information available for: Lidocaine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Paracervical Block During Office Hysteroscopy: A Randomized Double Blind Placebo-Controlled Trial

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
1: Experimental Lidocaine paracervical block	Drug: Lidocaine paracervical block 5cc 1% lidocaine injection in each paracervical region
2: Placebo Comparator 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

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

Responsible Party:	Montefiore Medical Center ( Scott Chudnoff, MD )
Study ID Numbers:	06-09-395
Study First Received:	December 16, 2008
Last Updated:	December 17, 2008
ClinicalTrials.gov Identifier:	NCT00811187 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Montefiore Medical Center:

Hysteroscopy
Pain medication
Lidocaine
Office Procedures

Study placed in the following topic categories:

Lidocaine
Central Nervous System Depressants
Anesthetics
Pain
Cardiovascular Agents

Anti-Arrhythmia Agents
Peripheral Nervous System Agents
Analgesics
Anesthetics, Local

Additional relevant MeSH terms:

Sensory System Agents
Therapeutic Uses
Physiological Effects of Drugs
Lidocaine
Central Nervous System Depressants
Anesthetics

Cardiovascular Agents
Anti-Arrhythmia Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Pharmacologic Actions
Anesthetics, Local

ClinicalTrials.gov processed this record on May 07, 2009