Paracervical Block for Pain Reduction in Saline Infusion Sonograms

Conditions

• Pain During Saline Infusion Sonogram

Eligibility Criteria

Sex

FEMALE

Age

18 Years - 50 Years

Healthy Volunteers

Not accepted

Interventions

• Lidocaine — DRUG
  10cc of 1% lidocaine buffered with 1cc 8.4% sodium bicarbonate, injected at 4 and 8 o'clock paracervical positions.
• Sham paracervical block — PROCEDURE
  A capped needle is pressed at 4 and 8 o'clock positions to mimic lidocaine block without injection.

Study Details

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.

Key Dates

Start date

Jul 2, 2025

Status verified

Jul 2025

Primary completion

Jul 31, 2026

Completion

Jul 31, 2026

Study Design

Enrollment

246 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Arms

• Experimental: Paracervical Block Arm
  Participants receive a paracervical block with 10cc 1% lidocaine buffered with 1cc sodium bicarbonate
• Placebo Comparator: Control Arm (No Block)
  Participants receive no anesthesia; a capped needle is pressed at the paracervical locations to mimic injection

Primary Outcome Measure

Change in pain intensity from baseline during tubal patency assessment [ Time Frame: Measured during the procedure, within 30 minutes of procedure start ]

Central Contacts

• Meaghan Jain, MD
  781-439-5947
  [email protected]
• Julian Gingold, MD, PhD
  914-997-1060
  [email protected]

Locations (1)

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