Phase 4
Completed N=58
Intrauterine Lidocaine Infusion for Essure Sterilization Procedures
Source: ClinicalTrials.gov NCT00613834 ↗Enrolled (actual)
58
Serious AEs
0.0%
Results posted
Dec 2019
Primary outcomePrimary: Change in Patient-perceived Pain Between Baseline and Cannulization — 29.5; 35 score on a scale
◆ Published Evidence
Emerging
13citations · ~1 / year
Intrauterine lidocaine infusion for pain management during outpatient transcervical tubal sterilization: a randomized controlled trial.
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.
Linked Publications
-
Intrauterine lidocaine infusion for pain management during outpatient transcervical tubal sterilization: a randomized controlled trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Patient-perceived Pain Between Baseline and Cannulization |
29.5; 35 | — |
| SECONDARY Patient Perceived Pain 30 Minutes Post-procedure |
20; 32.5 | — |
| SECONDARY Patient Satisfaction With the Essure Tubal Sterilization Procedure |
94; 93.5 | — |
Eligibility Criteria
Inclusion Criteria
- Female
- Age 18 or older
- Good general health, based on the opinion of the investigator
- Voluntarily requesting permanent sterilization
- Negative pregnancy test
- Agree to premedication with ibuprofen and ativan
- English speaking, or other language if an interpreter is available to be present at all points of the study procedure.
- Willing and able to sign an informed consent
- Willing to comply with the terms of the study
Exclusion Criteria
- Significant physical or mental health condition, based on the opinion of the investigator.
- Positive pregnancy test
- Request for IV/IM sedation prior to the start of the procedure
- Refusal of ibuprofen, ativan, or paracervical block
- Allergy to any study medication including lidocaine, ibuprofen, ativan, sodium bicarbonate
- History of toxic reaction to local anesthetics
- Known hepatic disease or liver dysfunction. (Lidocaine is metabolized by the liver.)
- Weight less than 100 pounds. [Any patient weighing less than 100 pounds would receive more than the recommended dose for their weight (4.5 mg/kg or 2 mg/lb)].
- Current participation in another research study which would interfere with the conduct of this study.
Data sourced from ClinicalTrials.gov (NCT00613834) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.