Intrauterine Lidocaine Infusion for Essure Sterilization Procedures
Information source: Oregon Health and Science University
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pain
Intervention: Lidocaine (Drug); Sterile Saline (Drug)
Phase: N/A
Status: Completed
Sponsored by: Oregon Health and Science University Official(s) and/or principal investigator(s): Michelle M. Isley, M.D., Principal Investigator, Affiliation: Oregon Health and Science University
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.
Clinical Details
Official title: Intrauterine Lidocaine Infusion for Pain Management During Outpatient Essure Transcervical Tubal Sterilization Procedures
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care
Primary outcome: Intrauterine lidocaine and patient perceived pain with Essure tubal sterilization as compared to the standard paracervical block.
Secondary outcome: To measure the amount of pain experienced during outpatient Essure procedures in the placebo group.To determine whether intrauterine lidocaine results in greater satisfaction with the Essure tubal sterilization experience. To obtain safety data on the absorption of intrauterine lidocaine in the non-pregnant uterus.
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 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
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Female.
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.
Locations and Contacts
Oregon Health & Science University, Portland, Oregon 97239, United States
Planned Parenthood of the Columbia Willamette, Portland, Oregon 97206, United States
Additional Information
Starting date: May 2007
Last updated: February 9, 2012
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