Intrauterine Lidocaine Infusion for Essure Sterilization Procedures

NCT ID: NCT00613834

Last Updated: 2019-12-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 58 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-05-31
• Study Completion Date: 2008-06-30

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.

Conditions

Pain

Keywords

Essure sterilization; pain management; intrauterine lidocaine infusion

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: QUADRUPLE

Study Groups

Lidocaine group

Participants receive transcervical instillation of 5 ml 4% lidocaine solution 3 minutes prior to transcervical tubal sterilization

Group Type: EXPERIMENTAL

Lidocaine

Intervention Type: DRUG

5 ml intrauterine infusion of 4% lidocaine using a sterile 3 mm Novak curette will be infused slowly over 4 1/2 minutes

Control group

Participants receive transcervical instillation of 5 ml saline 3 minutes prior to transcervical tubal sterilization

Group Type: PLACEBO_COMPARATOR

Sterile Saline

Intervention Type: DRUG

5 ml intrauterine infusion of sterile saline using a sterile 3 mm Novak curette will be infused slowly over 4 1/2 minutes

Interventions

Lidocaine

5 ml intrauterine infusion of 4% lidocaine using a sterile 3 mm Novak curette will be infused slowly over 4 1/2 minutes

Intervention Type: 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

Intervention Type: DRUG

Other Intervention Names

Xylocaine

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Oregon Health and Science University

OTHER

Sponsor Role: lead

Responsible Party

Alison Edelman

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Michelle M. Isley, M.D.

Role: PRINCIPAL_INVESTIGATOR

Oregon Health and Science University

Locations

Planned Parenthood of the Columbia Willamette

Portland, Oregon, United States

Oregon Health & Science University

Portland, Oregon, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 22067774 (View on PubMed)

Related Links

http://www.ohsuwomenshealth.com/research/index.html

(Women's Health Research Unit website)

Other Identifiers

OHSU FAMPLAN 3343

Identifier Type: -

Identifier Source: org_study_id