Randomized Trial of Lidocaine Paracervical Block to Reduce Pain During Saline Infusion Sonograms for Fertility Evaluation of Uterine and Tubal Health

What this Trial Is About

Pain management during gynecologic procedures, especially saline infusion sonograms SIS used in fertility evaluations, is an important womens health issue as inadequate pain control may cause avoidance of necessary care. This trial evaluates whether local anesthesia using a lidocaine paracervical block reduces pain during SIS compared to a placebo procedure in women undergoing uterine and tubal assessments. The goal is to improve the patient experience and accessibility of SIS in fertility care. Participants are randomly assigned to receive either a paracervical block with 10cc of 1% lidocaine buffered with sodium bicarbonate or a placebo where a capped needle mimics injection without anesthesia. The study compares self-reported pain scores at multiple points during the procedure, including during the block administration, balloon catheter placement, saline infusion, and up to one hour after the procedure. This is a Phase 4, single-blind, parallel-group study. Women enrolled undergo saline infusion sonograms with balloon catheter assessments after taking ibuprofen beforehand. Researchers collect pain ratings during and after the procedure, record procedural details such as use of tenaculum or uterine sound, and monitor any inability to receive the block. The study measures changes in pain intensity during tubal patency assessment as the primary outcome and includes multiple secondary pain intensity measures. The trial runs from July 2025 to July 2027.

Paracervical Block for Pain Reduction in Saline Infusion Sonograms