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Paracervical Block for Pain Reduction in Saline Infusion Sonograms

Paracervical Block for Saline Infusion Sonogram in Fertility Evaluation: A Randomized Controlled Trial

Who can join

Ages 18 to 50 · Women

Inclusion Criteria:

* 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 Criteria:

* 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

About the study

Inadequate pain management during gynecologic procedures is a growing women's health concern, especially as it reduces access to care for patients who may subsequently avoid further treatment. Although recent evidence has shown that local anesthesia reduces pain during certain gynecologic procedures, such as intrauterine (IUD) placements, there is still limited evidence on the effectiveness of local anesthesia during saline infusion sonograms (SIS). The SIS is a routine procedure performed during the fertility workup to evaluate the uterus and fallopian tubes. In this study, the investigators are determining if local anesthesia improves the pain experience for women undergoing SIS by randomly assigning 246 women to receive local anesthesia (lidocaine) versus placebo (capped needle pressing against areas where the paracervical block is performed). The investigators will compare their self-reported pain scores at various points in the procedure. If local anesthesia is shown to be effective at reducing pain, this could ultimately improve the patient experience in fertility evaluations moving forward and make this procedure more accessible to all women.

What is being tested

• Lidocaine (drug)
• Sham paracervical block (procedure)

Sponsor: Montefiore Medical Center · Participants: 246 · Started: Jul 2, 2025

Contact the study team

• Meaghan Jain, MD · Phone: 781-439-5947
• Julian Gingold, MD, PhD · Phone: 914-997-1060

Official record on ClinicalTrials.gov — NCT07048769

Locations in the U.S.

From ClinicalTrials.gov, data retrieved Oct 3, 2026. Each study sets its own eligibility; the study team decides who can join.