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

This study has been completed.

Sponsor:

Information provided by:

Oregon Health and Science University

ClinicalTrials.gov Identifier:

NCT00121329

First received: July 13, 2005

Last updated: July 19, 2005

Last verified: July 2005

History of Changes

Tracking Information

First Received Date ^ICMJE

July 13, 2005

Last Updated Date

July 19, 2005

Start Date ^ICMJE

Not Provided

Primary Completion Date

Not Provided

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

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

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

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double-Blind
Primary Purpose: Treatment

Condition ^ICMJE

Pain

Intervention ^ICMJE

Drug: Intrauterine lidocaine infusion 4%

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

December 2004

Primary Completion Date

Not Provided

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 Number ^ICMJE

NCT00121329

Other Study ID Numbers ^ICMJE

OHSU IRB 6876

Has Data Monitoring Committee

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

Oregon Health and Science University

Collaborators ^ICMJE

Not Provided

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

To Top