Actively Recruiting

Phase 4
Age: 18Years - 50Years
FEMALE
NCT07048769

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

Age: 18Years - 50Years
FEMALE

Eligibility Criteria

Eligible

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
Not Eligible

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

Complete this quick 3-step screening to check your eligibility

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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

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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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