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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

Page last updated: August 23, 2015

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