AzTrials
AzTrials

PainPhase 4NCT00613834

Intrauterine Lidocaine Infusion for Essure Sterilization Procedures

A Phase 4 study testing Lidocaine and Sterile Saline in people with Pain, run by Oregon Health and Science University at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women onlyHealthy volunteers can take part
Conditions the study is for
Pain
What is being tested?
Lidocaine and Sterile Saline
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
58 participants
Where
2 sitesUnited States
Study dates
May 2007to Jun 2008
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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
Show all 9Show fewer
  • 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

Who cannot join

  • 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
Show all 9Show fewer
  • 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.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Planned Parenthood of the Columbia Willamette

    Portland, Oregon, 97206

  • Oregon Health & Science University

    Portland, Oregon, 97239

Other trials in United States

About this study

Official title: 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.

Read the 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
Being tested
Lidocaine, Sterile Saline
Keywords
Essure sterilization, pain management, intrauterine lidocaine infusion
Medical subject headings
Pain, Agnosia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LidocaineDrug

    Also called Xylocaine

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

  • Sterile SalineDrug

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

Study groups in NCT00613834
Study groupRoleWhat they receive
Lidocaine groupExperimentalParticipants receive transcervical instillation of 5 ml 4% lidocaine solution 3 minutes prior to transcervical tubal sterilization
Receives: Drug: Lidocaine
Control groupPlacebo comparatorParticipants receive transcervical instillation of 5 ml saline 3 minutes prior to transcervical tubal sterilization
Receives: Drug: Sterile Saline

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Immediately after speculum insertion and immediately after cannulization

Secondary outcomes (2)

  1. Patient Perceived Pain 30 Minutes Post-procedure

    Patients rated their pain 30 minutes after speculum removal 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.

    Measured: 30 minutes post-procedure

  2. Patient Satisfaction With the Essure Tubal Sterilization Procedure

    Patients reported their overall satisfaction with the Essure tubal sterilization procedure using a Visual Analog scale (VAS), range 0-100. A score of 0 indicates lowest possible satisfaction and a score of 100 indicates highest possible satisfaction.

    Measured: 30 minutes post-procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Feb 2008 (estimated)
  2. Study startMay 2007
  3. Primary completionJun 2008
  4. Study completionJun 2008

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
58 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00613834
Sponsor's protocol ID
OHSU FAMPLAN 3343
Status last verified
Dec 2019
First submitted
31 Jan 2008
Last updated
19 Dec 2019
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • 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.

    PubMed 22067774

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Lidocaine and Sterile Saline in people with Pain, run by Oregon Health and Science University at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Dec 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Patient-perceived Pain Between Baseline and Cannulization (time frame: Immediately after speculum insertion and immediately after cannulization). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00613834, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2019.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in