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Paracervical Block During Office Hysteroscopy

NCT00811187 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2019-12-11

Study results available
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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.

Conditions

  • Paracervical Block

Interventions

DRUG

Lidocaine paracervical block

5cc 1% lidocaine injection in each paracervical region

DRUG

Normal Saline

5cc Normal Saline injection in each paracervical region

Sponsors & Collaborators

  • Montefiore Medical Center

    lead OTHER

Principal Investigators

  • Scott Chudnoff, MD · Montefiore Medical Center/Albert Einstein College of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2007-03-31
Primary Completion
2008-03-31
Completion
2008-09-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00811187 on ClinicalTrials.gov