Clinical trial NCT00613834: Intrauterine Lidocaine Infusion for Essure Sterilization Procedures
Official title: Intrauterine Lidocaine Infusion for Pain Management During Outpatient Essure Transcervical Tubal Sterilization Procedures
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pain
Keywords: Essure sterilization
pain management
intrauterine lidocaine infusion
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
First posted: 2008-02-13
Enrollment: 58
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Change in Patient-perceived Pain Between Baseline and Cannulization
timeFrame: Immediately after speculum insertion and immediately after cannulization
Secondary outcomes:
measure: Patient Perceived Pain 30 Minutes Post-procedure
timeFrame: 30 minutes post-procedure
measure: Patient Satisfaction With the Essure Tubal Sterilization Procedure
timeFrame: 30 minutes post-procedure
Other outcomes:
Locations:
city: Portland
country: United States
facility: Planned Parenthood of the Columbia Willamette
state: Oregon
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
Study officials:
affiliation: Oregon Health and Science University
name: Michelle M. Isley, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Isley MM, Jensen JT, Nichols MD, Lehman A, Bednarek P, Edelman A. Intrauterine lidocaine infusion for pain management during outpatient transcervical tubal sterilization: a randomized controlled trial. Contraception. 2012 Mar;85(3):275-81. doi: 10.1016/j.contraception.2011.06.015. Epub 2011 Aug 17.