4% Intrauterine Lidocaine Infusion for Pain Management in First Trimester Abortions

NCT ID: NCT00121329

Last Updated: 2005-07-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Completion Date

2004-12-31

Brief Summary

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Recent studies have investigated the use of local anesthetics (i.e. lidocaine, mepivacaine) to lessen the pain experienced with minor gynecologic procedures such as endometrial biopsy and office hysteroscopy. Local anesthetic injected into the uterine cavity has been demonstrated effective in some studies at decreasing patient pain associated with these intrauterine procedures at an anesthetic concentration of at least 2%. Based on this evidence, we hypothesized that an intrauterine lidocaine infusion may reduce patient pain during first trimester abortions.

Detailed Description

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Conditions

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Pain

Keywords

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Pain with procedures

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Intrauterine lidocaine infusion 4%

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Age \> 18 years old
* Good general health
* English speaking
* Confirmation of gestational age by ultrasound
* Body weight \> 100 lbs.
* Pregnancy \< 11 weeks
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Oregon Health and Science University

OTHER

Sponsor Role lead

Principal Investigators

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Alison B Edelman, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Oregon Health and Science University

Locations

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Planned Parenthood of the Columbia Willamette

Portland, Oregon, United States

Site Status

Countries

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United States

Other Identifiers

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OHSU IRB 6876

Identifier Type: -

Identifier Source: org_study_id