At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 58 enrolled
Drug / intervention
Lidocaine +1 moredrug
Likely dose
Lidocaine 5 mlfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Intrauterine Lidocaine Infusion for Pain Management During Outpatient Essure Transcervical Tubal Sterilization Procedures
In Brief
A Phase 4 clinical trial evaluating Lidocaine and Sterile Saline for Pain. Completed, enrolled 58 participants across 2 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPain
CountriesUnited States
Collaborators--
Timeline
Phase 4CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartMay 2007
First PostedFeb 2008
Primary CompletionJun 2008
TodayJul 2026
First PostedFeb 13, 2008
Enrollment StartMay 1, 2007
Primary CompletionJun 1, 2008
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 18.4 years ago
Interventions
Lidocainedrug
5 ml intrauterine infusion of 4% lidocaine using a sterile 3 mm Novak curette will be infused slowly over 4 1/2 minutes
Sterile Salinedrug
5 ml intrauterine infusion of sterile saline using a sterile 3 mm Novak curette will be infused slowly over 4 1/2 minutes