Recruiting

Lidocaine

Sponsor:

Montefiore Medical Center

Code:

NCT07048769

Conditions

Pain During Saline Infusion Sonogram

Eligibility Criteria

Sex: Female

Age: 18 - 50

Healthy Volunteers: Not accepted

Interventions

Lidocaine

Sham paracervical block

Study Details

Brief 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.

Conditions

Pain During Saline Infusion Sonogram

Study ID

NCT07048769

Start date

Jul 2, 2025

Status verified date

Jul, 2026

Completion date

Jul, 2027

Anticipated

Primary completion date

Jul, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 50

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Undergoing uterine cavity and tubal patency evaluation via saline infusion sonogram with balloon catheter at Montefiore Institute for Reproductive Medicine and Health
  • Pre-medicated with 600-800 mg ibuprofen taken 30 minutes to 4 hours prior to procedure
  • Able to provide informed consent in English or Spanish
  • Capacity to consent

Exclusion Criteria:

  • Undergoing uterine cavity evaluation only (without tubal patency assessment)
  • No ibuprofen pre-medication prior to procedure
  • Received misoprostol within 24 hours prior to procedure
  • Known allergy to lidocaine

Study Design

Enrollment

246 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

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

Interventions

Lidocaine

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

Sham paracervical block

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

Central contacts

Locations

Montefiore's Institute for Reproductive Medicine and Health

Recruiting

Hartsdale, New York, United States, 10530

Contacts

Principal Investigator:

Julian Gingold, MD, PhD

More Information

Sponsor

Montefiore Medical Center

Last update posted

Jul 9, 2026

Last verified

Jul, 2026

Keywords

  • paracervical block
  • saline infusion sonogram
  • Fertility evaluation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Montefiore Medical Center on 2026-07-09.