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
  Purpose

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.


Condition Intervention
Pain
Drug: Lidocaine
Drug: Sterile Saline

Study Type: Interventional
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
Official Title: Intrauterine Lidocaine Infusion for Pain Management During Outpatient Essure Transcervical Tubal Sterilization Procedures

Resource links provided by NLM:


Further study details as provided by Oregon Health and Science University:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 58
Study Start Date: May 2007
Study Completion Date: June 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 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
Placebo Comparator: 2 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

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00613834

Locations
United States, Oregon
Oregon Health & Science University
Portland, Oregon, United States, 97239
Planned Parenthood of the Columbia Willamette
Portland, Oregon, United States, 97206
Sponsors and Collaborators
Oregon Health and Science University
Investigators
Principal Investigator: Michelle M. Isley, M.D. Oregon Health and Science University
  More Information

No publications provided by Oregon Health and Science University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Michelle Isley, MD, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT00613834     History of Changes
Other Study ID Numbers: OHSU FAMPLAN 3343
Study First Received: January 31, 2008
Last Updated: February 9, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Oregon Health and Science University:
Essure sterilization
pain management
intrauterine lidocaine infusion

Additional relevant MeSH terms:
Lidocaine
Disinfectants
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Anti-Arrhythmia Agents
Cardiovascular Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Anti-Infective Agents

ClinicalTrials.gov processed this record on August 28, 2014