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

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00121329
• Other study ID #: OHSU IRB 6876
• Status: Completed
• Phase: N/A
• First received: July 13, 2005
• Last updated: July 19, 2005
• Est. completion date: December 2004

Study information

• Verified date: July 2005
• Source: Oregon Health and Science University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: December 2004
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age > 18 years old

• Good general health

• English speaking

• Confirmation of gestational age by ultrasound

• Body weight > 100 lbs.

• Pregnancy < 11 weeks

Study Design

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

Related Conditions & MeSH terms

• Pain

Intervention

Drug:
• Intrauterine lidocaine infusion 4%

Locations

Country	Name	City	State
United States	Planned Parenthood of the Columbia Willamette	Portland	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
Oregon Health and Science University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	VAS scores during cervical dilation and uterine aspiration
Secondary	Patient satisfaction, symptoms, lidocaine levels