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Pain During Saline Infusion SonogramPainFertilityDrugProcedurePhase 4

What this study is

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.

What's being tested

  • Lidocaine

    Intervention · DRUG

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

  • Sham paracervical block

    Intervention · PROCEDURE

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

Study details

Official title
Paracervical Block for Saline Infusion Sonogram in Fertility Evaluation: A Randomized Controlled Trial
Sponsor
Montefiore Medical Center
Conditions
Pain During Saline Infusion Sonogram
Enrolling
246 people
Starts
2025-07-02
Est. completion
2027-07
Design
Single-blind, randomized, parallel groups, Phase 4
Record
View on ClinicalTrials.gov ↗