Paracervical Block for Pain Reduction in Saline Infusion Sonograms

Recruiting now · Phase 4 · Has a placebo group

Conditions studied: Pain During Saline Infusion Sonogram

In brief

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.

Key facts

Study ID

NCT07048769

Run by

Montefiore Medical Center

People needed

246

Starts

2025-07-02

Expected to finish

2027-07-01

Last updated by the study team

2026-07-09

Who can join

Age: 18 and older, up to 50. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Montefiore's Institute for Reproductive Medicine and Health — Hartsdale, New York, United States (enrolling)

Full record on ClinicalTrials.gov

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