RECRUITING

Paracervical Block for Pain Reduction in Saline Infusion Sonograms

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-07-02
Study Completion:2026-07
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT07048769

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 50 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * Undergoing uterine cavity and tubal patency evaluation via saline infusion sonogram with balloon catheter at Montefiore Institute for Reproductive Medicine and Health
  2. * Pre-medicated with 600-800 mg ibuprofen taken 30 minutes to 4 hours prior to procedure
  3. * Able to provide informed consent in English or Spanish
  4. * Capacity to consent
  1. * Undergoing uterine cavity evaluation only (without tubal patency assessment)
  2. * No ibuprofen pre-medication prior to procedure
  3. * Received misoprostol within 24 hours prior to procedure
  4. * Known allergy to lidocaine

Contacts and Locations

Study Contact

Meaghan Jain, MD
CONTACT
781-439-5947
mejain@montefiore.org
Julian Gingold, MD, PhD
CONTACT
914-997-1060
jgingold@montefiore.org

Principal Investigator

Julian Gingold, MD, PhD
PRINCIPAL_INVESTIGATOR
Montefiore Medical Center

Study Locations (Sites)

Montefiore's Institute for Reproductive Medicine and Health
Hartsdale, New York, 10530
United States

Collaborators and Investigators

Sponsor: Montefiore Medical Center

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-07-02
Study Completion Date2026-07

Study Record Updates

Study Start Date2025-07-02
Study Completion Date2026-07

Terms related to this study

Keywords Provided by Researchers

  • paracervical block
  • saline infusion sonogram
  • Fertility evaluation

Additional Relevant MeSH Terms

  • Pain During Saline Infusion Sonogram