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Paracervical Block During Office Hysteroscopy

NCT ID: NCT00811187

Last Updated: 2019-12-11

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-03-31

Study Completion Date

2008-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Paracervical Block

Keywords

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Hysteroscopy Pain medication Lidocaine Office Procedures

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Lidocaine paracervical block

5cc 1% lidocaine injection in each paracervical region

Group Type EXPERIMENTAL

Lidocaine paracervical block

Intervention Type DRUG

5cc 1% lidocaine injection in each paracervical region

Saline placebo injection

5cc Normal Saline injection in each paracervical region

Group Type PLACEBO_COMPARATOR

Normal Saline

Intervention Type DRUG

5cc Normal Saline injection in each paracervical region

Interventions

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Lidocaine paracervical block

5cc 1% lidocaine injection in each paracervical region

Intervention Type DRUG

Normal Saline

5cc Normal Saline injection in each paracervical region

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Planned secondary procedures
* Lidocaine allergy
* Repeat procedures
Minimum Eligible Age

21 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Montefiore Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Scott Chudnoff, MD

Role: PRINCIPAL_INVESTIGATOR

Montefiore Medical Center/Albert Einstein College of Medicine

Locations

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Centennial Women's Center / Montefiore Medical Center

The Bronx, New York, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 20027030 (View on PubMed)

Other Identifiers

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06-09-395

Identifier Type: -

Identifier Source: org_study_id