Actively Recruiting

Phase 4
Age: 18Years - 50Years
FEMALE
ID07048769

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

Led by Montefiore Medical Center · Updated on 2025-07-04

246

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Pain management during gynecologic procedures is an important women's health issue, especially because inadequate pain control can discourage patients from seeking further care. This research investigates whether local anesthesia, specifically a lidocaine paracervical block, can reduce pain during saline infusion sonograms (SIS), a routine fertility evaluation that examines the uterus and fallopian tubes. The study compares pain experiences in women receiving lidocaine versus a placebo to better understand if local anesthesia improves comfort during SIS. Participants are randomly assigned to one of two groups: one receives a paracervical block with 10cc of 1% lidocaine buffered with sodium bicarbonate, while the other receives a placebo procedure where a capped needle is pressed against the paracervical area without injection. The trial is designed as a randomized controlled study and includes women undergoing saline infusion sonograms that assess both uterine cavity and tubal patency using a balloon catheter. Women in the study will report pain intensity at multiple points throughout the procedure, including during anesthesia administration, catheter placement, saline infusion, and after completion. The primary measurement focuses on pain during tubal patency assessment within 30 minutes of procedure start. Researchers will also monitor the need for additional devices and any inability to receive the anesthesia. The trial runs until July 2026 and aims to provide clearer guidance on pain management during fertility evaluations.

CONDITIONS

Brief Title

Paracervical Block for Pain Reduction in Saline Infusion Sonograms

Who Can Participate

Age: 18Years - 50Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
Not Eligible

You will not qualify if you...

  • 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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Single day procedure

Participants undergo a saline infusion sonogram with balloon catheter to evaluate uterine cavity and tubal patency. They receive either a paracervical block with lidocaine or a sham procedure to manage pain during the sonogram.

1 visit (in-person)

Follow-up

Duration - Approximately 1 hour after procedure

Pain intensity is assessed up to 1 hour after the procedure to evaluate pain management effectiveness.

1 follow-up visit (in-person)

Trial Site Locations

Total: 1 location

1

Montefiore's Institute for Reproductive Medicine and Health

Hartsdale, New York, United States, 10530

Actively Recruiting

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Research Team

M

Meaghan Jain, MD

J

Julian Gingold, MD, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

2

Frequently Asked Questions

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Published Research Related To This Trial

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S S F Yung, S F Lai, M T Lam...

https://pubmed.ncbi.nlm.nih.gov/26434382

Pain Intensity During Ultrasound Assessment of Uterine Cavity and Tubal Patency With and Without Painkillers: Prospective Observational Study.

Inga Ludwin, Wellington P Martins, Carolina O Nastri...

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Evaluating different pain lowering medications during intrauterine device insertion: a systematic review and network meta-analysis.

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Reducing Pain During Intrauterine Device Insertion: A Randomized Controlled Trial in Adolescents and Young Women.

Aletha Y Akers, Caren Steinway, Sarita Sonalkar...

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Paracervical Block for Intrauterine Device Placement Among Nulliparous Women: A Randomized Controlled Trial.

Sheila K Mody, John Paul Farala, Berenice Jimenez...

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