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Pain Reduction in Saline Infusion Sonograms

This study is looking at ways to reduce pain during a saline infusion sonogram (SIS), a routine procedure to check the uterus and fallopian tubes during fertility evaluations. Researchers are comparing two approaches: one group will receive a paracervical block with lidocaine (a numbing medicine) injected near the cervix, and another group will receive a sham block where a capped needle is pressed without injection. You may be eligible if you are a woman between 18 and 50 years old, are having an SIS at Montefiore Institute for Reproductive Medicine and Health, and have taken ibuprofen before the procedure. The main goal is to see if lidocaine helps reduce pain during the tubal patency assessment part of the SIS.

Study design
This is an interventional study planning to enroll 246 women. Participants will be randomly assigned to receive either lidocaine or a sham procedure.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Pain intensity will be measured during the procedure, within 30 minutes of the procedure start.

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NCT07048769

Paracervical Block for Pain Reduction in Saline Infusion Sonograms

Recruiting
PHASE4Ages 18–50InterventionalSupportive care
Montefiore Medical Center
~246 participants
Updated 2026-07-09 on ClinicalTrials.gov
What's tested:LidocaineSham paracervical block

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in pain intensity from baseline during tubal patency assessment
Measured over Measured during the procedure, within 30 minutes of procedure start

Conditions

Pain During Saline Infusion Sonogram

Explore related trials

Infertility

Where it's being run

1 sites across 1 states
New York1

Study leadership

  • Julian Gingold, MD, PhD · PRINCIPAL_INVESTIGATOR · Montefiore Medical Center

Who to contact

Meaghan Jain, MD
[email protected]
781-439-5947
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Undergoing uterine cavity and tubal patency evaluation via saline infusion sonogram with balloon catheter at Montefiore Institute for Reproductive Medicine and Health
Pre-medicated with 600-800 mg ibuprofen taken 30 minutes to 4 hours prior to procedure
Able to provide informed consent in English or Spanish
Capacity to consent

Exclusion

Undergoing uterine cavity evaluation only (without tubal patency assessment)
No ibuprofen pre-medication prior to procedure
Received misoprostol within 24 hours prior to procedure
Known allergy to lidocaine

What this trial measures

  • Change in pain intensity from baseline during tubal patency assessmentMeasured during the procedure, within 30 minutes of procedure start

    Pain intensity during tubal patency assessment will be assessed using a Visual Analog Scale (VAS) ranging from 0 to 100 mm, where 0 represents "no pain" and 100 represents "worst possible pain." The VAS score will be recorded at the time of saline infusion sonogram assessing tubal patency. The pain intensity will be evaluated as a change from their baseline level of pain. Results will be summarized by study arm and analyzed using basic descriptive statistics.