Intrauterine Lidocaine Infusion for Essure Sterilization Procedures

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Michelle Isley, Oregon Health and Science University
ClinicalTrials.gov Identifier:
NCT00613834
First received: January 31, 2008
Last updated: February 9, 2012
Last verified: February 2012

January 31, 2008
February 9, 2012
May 2007
June 2008   (final data collection date for primary outcome measure)
Intrauterine lidocaine and patient perceived pain with Essure tubal sterilization as compared to the standard paracervical block. [ Time Frame: After enrollment is complete ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00613834 on ClinicalTrials.gov Archive Site
  • To measure the amount of pain experienced during outpatient Essure procedures in the placebo group. [ Time Frame: After enrollment is complete ] [ Designated as safety issue: No ]
  • To determine whether intrauterine lidocaine results in greater satisfaction with the Essure tubal sterilization experience. [ Time Frame: After enrollment is complete ] [ Designated as safety issue: No ]
  • To obtain safety data on the absorption of intrauterine lidocaine in the non-pregnant uterus. [ Time Frame: After enrollment is complete ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Intrauterine Lidocaine Infusion for Essure Sterilization Procedures
Intrauterine Lidocaine Infusion for Pain Management During Outpatient Essure Transcervical Tubal Sterilization Procedures

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Pain
  • Drug: Lidocaine
    5 ml intrauterine infusion of 4% lidocaine using a sterile 3 mm Novak curette will be infused slowly over 4 1/2 minutes
  • Drug: Sterile Saline
    5 ml intrauterine infusion of sterile saline using a sterile 3 mm Novak curette will be infused slowly over 4 1/2 minutes
  • Experimental: 1
    Intervention: Drug: Lidocaine
  • Placebo Comparator: 2
    Intervention: Drug: Sterile Saline
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
58
June 2008
June 2008   (final data collection date for primary outcome measure)

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.
Female
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00613834
OHSU FAMPLAN 3343
No
Michelle Isley, Oregon Health and Science University
Oregon Health and Science University
Not Provided
Principal Investigator: Michelle M. Isley, M.D. Oregon Health and Science University
Oregon Health and Science University
February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP