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

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ClinicalTrials.gov Identifier: NCT00121329
Recruitment Status : Completed
First Posted : July 21, 2005
Last Update Posted : July 21, 2005
Sponsor:
Information provided by:
Oregon Health and Science University

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.

Condition or disease Intervention/treatment Phase
Pain Drug: Intrauterine lidocaine infusion 4% Not Applicable

Study Type : Interventional  (Clinical Trial)
Enrollment : 80 participants
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
Study Completion Date : December 2004

Resource links provided by the National Library of Medicine

U.S. FDA Resources




Primary Outcome Measures :
  1. VAS scores during cervical dilation and uterine aspiration

Secondary Outcome Measures :
  1. Patient satisfaction, symptoms, lidocaine levels


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

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

ClinicalTrials.gov Identifier: NCT00121329     History of Changes
Other Study ID Numbers: OHSU IRB 6876
First Posted: July 21, 2005    Key Record Dates
Last Update Posted: July 21, 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