Intrauterine Lidocaine Infusion for Essure Sterilization Procedures

NCT00613834 | Completed Phase 4 Results FDA Drug

• 1 other identifier: OHSU FAMPLAN 3343
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 2

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.

Conditions

Pain

Keywords

Essure sterilization; pain management; intrauterine lidocaine infusion

Outcome Measures

Primary Outcomes (1)

• Change in Patient-perceived Pain Between Baseline and Cannulization

  Patients rated their pain following speculum insertion (used as baseline) and after insertion of a cannula into both fallopian tubes. Reported pain during cannulization of the right and left fallopian tubes were averaged to obtain the measurement of pain at cannulization. Pain was reported using a Visual Analog Scale (VAS, range 0-100), where a score of 0 indicates no pain and a score of 100 indicates the worst pain imaginable. Baseline pain levels were subtracted from average pain during cannulization: a negative change in VAS score between baseline and cannulization indicates less pain during cannulization and a positive change in VAS score indicates more pain during cannulization.

  Immediately after speculum insertion and immediately after cannulization

Secondary Outcomes (2)

• Patient Perceived Pain 30 Minutes Post-procedure

  30 minutes post-procedure

• Patient Satisfaction With the Essure Tubal Sterilization Procedure

  30 minutes post-procedure

Study Arms (2)

Lidocaine group

EXPERIMENTAL

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

Drug: Lidocaine

Control group

PLACEBO COMPARATOR

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

Drug: Sterile Saline

Interventions

Lidocaine DRUG

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

Also known as: Xylocaine

Lidocaine group

Sterile Saline DRUG

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

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Oregon Health and Science University: lead

Study Sites (2)

Planned Parenthood of the Columbia Willamette

Portland, Oregon, 97206, United States

Location

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

Related Publications (1)

• 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.

  PMID: 22067774 DERIVED

Related Links

• (Women's Health Research Unit website)

MeSH Terms

Conditions

Pain; Agnosia

Interventions

Lidocaine

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Limitations and Caveats

Difference in reported abortions between the two groups. Data not included on three subjects in saline group because the subjects could not tolerate the procedure.

Results Point of Contact

• Title: Dr. Michelle Isley
• Organization: The Ohio State University

Michelle.Isley@osumc.edu

614-293-4203

Study Officials

• Michelle M. Isley, M.D.

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 31, 2008
• First Posted: February 13, 2008
• Study Start: May 1, 2007
• Primary Completion: June 1, 2008
• Study Completion: June 1, 2008
• Last Updated: December 19, 2019
• Results First Posted: December 19, 2019

Record last verified: 2019-12

Locations

US (2)