Ignite Creation Date:
2025-12-25 @ 2:39 AM
Ignite Modification Date:
2026-03-04 @ 1:38 PM
Study NCT ID:
NCT00613834
Status:
COMPLETED
Last Update Posted:
2019-12-19
First Post:
2008-01-31
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Intrauterine Lidocaine Infusion for Essure Sterilization Procedures
Sponsor:
Oregon Health and Science University
Organization:
Study Overview
Official Title:
Intrauterine Lidocaine Infusion for Pain Management During Outpatient Essure Transcervical Tubal Sterilization Procedures
Status:
COMPLETED
Status Verified Date:
2019-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to assess the level of pain women experience with an Essure procedure and the effect that lidocaine might have on that pain. We will also assess the absorption of lidocaine in the uterus by measuring lidocaine levels in the blood.
Detailed Description:
We intend to conduct a randomized, blinded, and placebo- controlled clinical trial at Oregon Health and Science University and Planned Parenthood of the Columbia Willamette to determine if intrauterine lidocaine infusion will decrease the amount of pain subjects experience during and after Essure transcervical tubal sterilization.
We plan to enroll women who have selected Essure as their method of tubal sterilization who will be randomized to one of two groups on the days of their procedures. Subjects in Group 1, the treatment group, will receive a standard paracervical block with lidocaine intrauterine infusion and subjects in Group 2, the control group, will receive a standard paracervical block with saline intrauterine infusion. The subjects will be asked to rate their pain on a 100 mm Visual Analog Scale (VAS) at five points during the procedure and once thirty minutes following the procedure. Subjects will also be asked to rate their overall satisfaction with their care prior to leaving the recovery room.
We plan to enroll women who have selected Essure as their method of tubal sterilization who will be randomized to one of two groups on the days of their procedures. Subjects in Group 1, the treatment group, will receive a standard paracervical block with lidocaine intrauterine infusion and subjects in Group 2, the control group, will receive a standard paracervical block with saline intrauterine infusion. The subjects will be asked to rate their pain on a 100 mm Visual Analog Scale (VAS) at five points during the procedure and once thirty minutes following the procedure. Subjects will also be asked to rate their overall satisfaction with their care prior to leaving the recovery room.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: