NCT00121329

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Completion

Last participant's last visit for all outcomes

December 1, 2004

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

July 13, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 21, 2005

Completed
Last Updated

July 21, 2005

Status Verified

July 1, 2005

First QC Date

July 13, 2005

Last Update Submit

July 19, 2005

Conditions

Pain

Keywords

Pain with procedures

Outcome Measures

Primary Outcomes (1)

  • VAS scores during cervical dilation and uterine aspiration

Secondary Outcomes (1)

  • Patient satisfaction, symptoms, lidocaine levels

Interventions

Intrauterine lidocaine infusion 4%DRUG

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Planned Parenthood of the Columbia Willamette

Portland, Oregon, 97206, United States

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Alison B Edelman, MD, MPH

    Oregon Health and Science University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 13, 2005

First Posted

July 21, 2005

Study Completion

December 1, 2004

Last Updated

July 21, 2005

Record last verified: 2005-07

Locations

US(1)