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

This study has been completed.

First Received on July 13, 2005. Last Updated on July 19, 2005 History of Changes

Sponsor:	Oregon Health and Science University
Information provided by:	Oregon Health and Science University
ClinicalTrials.gov Identifier:	NCT00121329

Purpose

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.

Condition	Intervention
Pain	Drug: Intrauterine lidocaine infusion 4%

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Single Group Assignment Masking: Double-Blind Primary Purpose: Treatment
Official Title:	4% Intrauterine Lidocaine Infusion for Pain Management in First Trimester Abortions

Resource links provided by NLM:

Drug Information available for: Lidocaine

U.S. FDA Resources

Further study details as provided by Oregon Health and Science University:

Primary Outcome Measures:

VAS scores during cervical dilation and uterine aspiration

Secondary Outcome Measures:

Patient satisfaction, symptoms, lidocaine levels

Estimated Enrollment:	80
Estimated Study Completion Date:	December 2004

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00121329

Locations

United States, Oregon
Planned Parenthood of the Columbia Willamette
Portland, Oregon, United States, 97206

Sponsors and Collaborators

Oregon Health and Science University

Investigators

Principal Investigator:

Alison B Edelman, MD, MPH

Oregon Health and Science University

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00121329 History of Changes
Other Study ID Numbers:	OHSU IRB 6876
Study First Received:	July 13, 2005
Last Updated:	July 19, 2005
Health Authority:	United States: Institutional Review Board

Keywords provided by Oregon Health and Science University:

Pain with procedures

Additional relevant MeSH terms:

Lidocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions

Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Anti-Arrhythmia Agents
Cardiovascular Agents

ClinicalTrials.gov processed this record on February 12, 2012