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RECRUITING
NCT07048769
PHASE4

Paracervical Block for Pain Reduction in Saline Infusion Sonograms

Sponsor: Montefiore Medical Center

View on ClinicalTrials.gov

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.

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

Key Details

Gender

FEMALE

Age Range

18 Years - 50 Years

Study Type

INTERVENTIONAL

Enrollment

246

Start Date

2025-07-02

Completion Date

2026-07

Last Updated

2025-07-04

Healthy Volunteers

No

Interventions

DRUG

Lidocaine

10cc of 1% lidocaine buffered with 1cc 8.4% sodium bicarbonate, injected at 4 and 8 o'clock paracervical positions.

PROCEDURE

Sham paracervical block

A capped needle is pressed at 4 and 8 o'clock positions to mimic lidocaine block without injection.

Locations (1)

Montefiore's Institute for Reproductive Medicine and Health

Hartsdale, New York, United States