Paracervical Block During Office Hysteroscopy
1 other identifier
interventional
80
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Mar 2007
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2008
CompletedFirst Submitted
Initial submission to the registry
December 16, 2008
CompletedFirst Posted
Study publicly available on registry
December 18, 2008
CompletedResults Posted
Study results publicly available
December 11, 2019
CompletedDecember 11, 2019
December 1, 2019
1 year
December 16, 2008
July 20, 2011
December 10, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
Lidocaine paracervical block
EXPERIMENTAL5cc 1% lidocaine injection in each paracervical region
Saline placebo injection
PLACEBO COMPARATOR5cc Normal Saline injection in each paracervical region
Interventions
5cc 1% lidocaine injection in each paracervical region
Eligibility Criteria
You may qualify if:
- Women eligible and scheduled for office hysteroscopic placement of essure devices
You may not qualify if:
- Planned secondary procedures
- Lidocaine allergy
- Repeat procedures
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Centennial Women's Center / Montefiore Medical Center
The Bronx, New York, 10467, United States
Related Publications (1)
Chudnoff S, Einstein M, Levie M. Paracervical block efficacy in office hysteroscopic sterilization: a randomized controlled trial. Obstet Gynecol. 2010 Jan;115(1):26-34. doi: 10.1097/AOG.0b013e3181c51ace.
PMID: 20027030DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Research Program Administrator
- Organization
- Montefiore Medical Center
Study Officials
- PRINCIPAL INVESTIGATOR
Scott Chudnoff, MD
Montefiore Medical Center/Albert Einstein College of Medicine
Publication Agreements
- PI is Sponsor Employee
- Yes
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 16, 2008
First Posted
December 18, 2008
Study Start
March 1, 2007
Primary Completion
March 1, 2008
Study Completion
September 1, 2008
Last Updated
December 11, 2019
Results First Posted
December 11, 2019
Record last verified: 2019-12