Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT07048769 · ClinicalTrials.gov registry record · Phase 4
Paracervical Block for Pain Reduction in Saline Infusion Sonograms
A Phase 4 study of Pain During Saline Infusion Sonogram, sponsored by Montefiore Medical Center.
- Recruiting
- Registry status
- Phase 4
- Development phase
- 246
- Enrollment target
- 1
- Study location
NCT07048769 is a Phase 4 study of Pain During Saline Infusion Sonogram that is actively recruiting participants, run by Montefiore Medical Center. The registered enrollment target is 246 participants. The trial reports 1 study location across 1 state.
The verdict
NCT07048769, a Phase 4 study of Pain During Saline Infusion Sonogram, is actively recruiting participants, sponsored by Montefiore Medical Center.
- RECRUITING
- Registry status
- Phase 4
- Development phase
- 246 participants
- Enrollment target
- 1
- Study location
Study Summary
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 Studied
Interventions
- DRUG Lidocaine
- PROCEDURE Sham paracervical block
Study Locations (1)
New York
- Montefiore's Institute for Reproductive Medicine and Health - Hartsdale
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 246 participants |
| Start Date | 2025-07-02 |
| Est. Completion | 2026-07 |
| Phase | Phase 4 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07048769
The ClinicalTrials.gov registry entry for NCT07048769 describes a study currently listed as recruiting, categorized as Phase 4. The registered enrollment target is 246 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Montefiore Medical Center, which has 345 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Pain During Saline Infusion Sonogram appearing as the primary indexed condition, and to 2 interventions - of which Lidocaine is the first listed.
NCT07048769 reports 1 study location spanning 1 distinct geographic area - top geographies include New York.
Frequently Asked Questions
What is clinical trial NCT07048769 about?
NCT07048769 is a clinical study titled "Paracervical Block for Pain Reduction in Saline Infusion Sonograms". 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...
What is the current status of trial NCT07048769?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 246 participants. The study started on 2025-07-02. Estimated completion is 2026-07.
What conditions does trial NCT07048769 study?
This clinical trial studies the following conditions: Pain During Saline Infusion Sonogram.
What interventions are being tested in trial NCT07048769?
The interventions under investigation include: Lidocaine (DRUG), Sham paracervical block (PROCEDURE).
Who is sponsoring clinical trial NCT07048769?
This trial is sponsored by Montefiore Medical Center, which has 345 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07048769 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.