Actively Recruiting
Paracervical Block for Pain Reduction in Saline Infusion Sonograms
Led by Montefiore Medical Center · Updated on 2025-07-04
246
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Paracervical Block for Pain Reduction in Saline Infusion Sonograms
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Montefiore's Institute for Reproductive Medicine and Health
Hartsdale, New York, United States, 10530
Actively Recruiting
Research Team
M
Meaghan Jain, MD
CONTACT
J
Julian Gingold, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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