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Recruiting Phase 4 Interventional

Paracervical Block for Pain Reduction in Saline Infusion Sonograms

ClinicalTrials.gov ID: NCT07048769

Public ClinicalTrials.gov record NCT07048769. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 5, 2026, 3:10 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT07048769
Recruitment status
Recruiting
Study type
Interventional
Phase
Phase 4
Lead sponsor
Montefiore Medical Center
Other
Enrollment
246 participants

Conditions and interventions

Interventions

Drug · Procedure

Eligibility (public fields only)

Age range
18 Years to 50 Years
Sex
Female
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jul 1, 2025
Primary completion
Jun 30, 2027
Completion
Jun 30, 2027
Last update posted
Jul 8, 2026

2025 – 2027

United States locations

U.S. sites
1
U.S. states
1
U.S. cities
1
Facility City State ZIP Site status
Montefiore's Institute for Reproductive Medicine and Health Hartsdale New York 10530 Recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT07048769, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jul 8, 2026 · Synced Sep 5, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT07048769 live on ClinicalTrials.gov.

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