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Paracervical Block for Saline Infusion Sonogram in Fertility Evaluation: A Randomized Controlled Trial
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.
Details
| Lead sponsor | Montefiore Medical Center |
|---|---|
| Phase | Phase 4 |
| Status | RECRUITING |
| Enrolment | 246 |
| Start date | 2025-07-02 |
| Completion | 2026-07 |
Conditions
- Pain During Saline Infusion Sonogram
Interventions
- Lidocaine
- Sham paracervical block
Primary outcomes
- Change in pain intensity from baseline during tubal patency assessment — Measured during the procedure, within 30 minutes of procedure start
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.
Countries
United States