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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: Recruiting Phase 4 study of Pain During Saline Infusion Sonogram, sponsored by Montefiore Medical Center.
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, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (53% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Pain intensity during tubal patency assessment will be assessed using a Visual Analog Scale (VAS) ranging from 0 to 100 mm, where 0 represents "no pain" and 100 represents "worst possible pain." The VAS score will be recorded at the time of saline infusion sonogram assessing tubal patency. The pain intensity will be evaluated as a change from their baseline level of pain. Results will be summarized by study arm and analyzed using basic descriptive statistics.
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 |
What NCT07048769 shows while recruiting
NCT07048769 is an interventional study that assigns participants to a tested intervention. The registered 246 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (53% lower).
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 a single indexed study location in 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
How this trial's enrollment target compares
Where NCT07048769's enrollment target sits among peer trials
246 356th of 2000 higher than 1,645 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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