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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00121329
First Posted: July 21, 2005
Last Update Posted: December 9, 2005
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Oregon Health and Science University
  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
Primary Purpose: Treatment
Official Title: 4% Intrauterine Lidocaine Infusion for Pain Management in First Trimester Abortions

Resource links provided by NLM:


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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00121329     History of Changes
Other Study ID Numbers: OHSU IRB 6876
First Submitted: July 13, 2005
First Posted: July 21, 2005
Last Update Posted: December 9, 2005
Last Verified: July 2005

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
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action