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

Tracking Information

First Received Date ^ICMJE

July 13, 2005

Last Updated Date

July 19, 2005

Start Date ^ICMJE

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

VAS scores during cervical dilation and uterine aspiration

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00121329 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Patient satisfaction, symptoms, lidocaine levels

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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

Study Phase

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment

Condition ^ICMJE

Pain

Intervention ^ICMJE

Drug: Intrauterine lidocaine infusion 4%

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

December 2004

Primary Completion Date

Eligibility Criteria ^ICMJE

Inclusion Criteria:

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

Gender

Female

Ages

18 Years and older

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00121329

Responsible Party

Study ID Numbers ^ICMJE

OHSU IRB 6876

Study Sponsor ^ICMJE

Oregon Health and Science University

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Alison B Edelman, MD, MPH

Oregon Health and Science University

Information Provided By

Oregon Health and Science University

Verification Date

July 2005

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP