Lidocaine for Pain Reduction in Saline Infusion Sonograms

Overseen By Julian Gingold, MD, PhD

Age: 18 - 65

Sex: Female

Trial Phase: Phase 4

Sponsor: Montefiore Medical Center

Must be taking: Ibuprofen

Must not be taking: Misoprostol

Disqualifiers: Uterine evaluation only, Lidocaine allergy, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 2

246 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether lidocaine, a local anesthetic, can reduce pain during a saline infusion sonogram (SIS), a procedure used to examine the uterus and fallopian tubes in fertility evaluations. Participants will receive either lidocaine or a placebo to assess pain reduction. The trial aims to make this procedure less painful and more accessible for women. Women already scheduled for an SIS with a balloon catheter, who have taken ibuprofen beforehand, and can consent in English or Spanish may be suitable for this study. As a Phase 4 trial, lidocaine is already FDA-approved and proven effective, and this research seeks to understand its benefits for more patients.

Do I need to stop my current medications for the trial?

The trial does not specify if you need to stop your current medications, but you must take ibuprofen before the procedure. If you have taken misoprostol within 24 hours before the procedure, you cannot participate.

What is the safety track record for lidocaine?

Research has shown that a paracervical block with lidocaine is generally safe for reducing pain during procedures like saline infusion sonograms. In one study with 96 women, it effectively reduced pain without causing major side effects. Another study found this method safe for preventing pain in premenopausal women undergoing similar procedures.

Lidocaine is also used in other medical settings, such as during IUD removals, to help with pain, indicating it is well-tolerated. Since this trial is in a later phase, evidence already supports its safety for human use.

Overall, previous findings suggest that lidocaine is a safe option for managing pain during these types of procedures. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Unlike other treatments for pain relief during saline infusion sonograms, which often involve oral painkillers or no anesthesia at all, lidocaine offers a direct and localized pain management solution. Lidocaine works by providing a paracervical block, numbing the area around the cervix, which can significantly reduce discomfort during the procedure. Researchers are excited about this treatment because it not only targets pain at its source but also acts quickly, delivering relief almost immediately, which could enhance patient comfort and experience during the sonogram.

What evidence suggests that lidocaine is effective for pain reduction during saline infusion sonograms?

Research has shown that a numbing injection with lidocaine during a saline infusion sonogram can greatly reduce pain. In this trial, participants in the Paracervical Block Arm will receive a paracervical block with lidocaine. One study found that women who received lidocaine reported significantly less pain than those who did not. Another study confirmed that lidocaine is a safe and effective method for preventing pain during these procedures. Specifically, women who used lidocaine had much lower pain scores than those who didn't. Overall, this evidence suggests that lidocaine can make the procedure more comfortable. ^{1 2 3 6 7}

Who Is on the Research Team?

Julian Gingold, MD, PhD

Principal Investigator

Montefiore Medical Center

Are You a Good Fit for This Trial?

This trial is for women undergoing saline infusion sonograms (SIS) as part of fertility evaluations. Participants should be those who have not received a paracervical block before and are willing to report their pain experience during the procedure.

Inclusion Criteria

Undergoing uterine cavity and tubal patency evaluation via saline infusion sonogram with balloon catheter at Montefiore Institute for Reproductive Medicine and Health

I am able to understand and agree to the study's requirements.

I took 600-800 mg of ibuprofen before my procedure.

Exclusion Criteria

I am having a check-up of my uterus without checking if my fallopian tubes are open.

I have not taken ibuprofen before the procedure.

I have taken misoprostol within the last 24 hours.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Procedure

Participants undergo saline infusion sonogram with either paracervical block or placebo to assess pain management

1 day

1 visit (in-person)

Immediate Follow-up

Pain intensity and patient satisfaction are assessed immediately and 1 hour after the procedure

1 hour

1 visit (in-person)

Follow-up

Participants are monitored for any delayed adverse effects and overall satisfaction with the procedure

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Lidocaine
• Sham paracervical block

Trial Overview The study tests if local anesthesia with lidocaine can reduce pain compared to a sham block (placebo) during SIS procedures. Women will be randomly assigned to either receive lidocaine or undergo a simulated block without actual medication.

How Is the Trial Designed?

Group I: Paracervical Block Arm Experimental Treatment 1 Intervention

Participants receive a paracervical block with 10cc 1% lidocaine buffered with 1cc sodium bicarbonate

Group II: Control Arm (No Block) Placebo Group 1 Intervention

Participants receive no anesthesia; a capped needle is pressed at the paracervical locations to mimic injection

Who Is Running the Clinical Trial?

Montefiore Medical Center

Lead Sponsor

Trials

468

Recruited

599,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07048769

Paracervical Block for Pain Reduction in Saline Infusion ... Another randomized controlled trial of 96 Turkish women found that paracervical block significantly reduced pain during saline infusion sonogram compared to ...

2. mdpi.com mdpi.com/2075-4418/12/12/3185

Evaluating the Effectiveness of Pharmacological Strategies ... In the nulliparous lidocaine group of patients, significant pain relief was lower with the use of lidocaine (3.0 +/− 1.4 vs. 6.3 +/− 1.5, p = ...

3. acog.org acog.org/clinical/clinical-guidance/clinical-consensus/articles/2025/05/pain-management-for-in-office-uterine-and-cervical-procedures

Pain Management for In-Office Uterine and Cervical ... Data show that paracervical block with lidocaine is superior to placebo 37 38 39. An RTC of 140 patients demonstrated significant pain reduction ...

4. trial.medpath.com trial.medpath.com/clinical-trial/2c75a94c5d66b48c/nct07048769-paracervical-block-saline-sonogram-fertility

Paracervical Block for Pain Reduction in Saline Infusion ... In women undergoing surgical abortion, a 20cc 1% lidocaine injection significantly reduced pain during dilation and aspiration regardless of ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5558303/

The optimal analgesic method in saline infusion sonogram Conclusion: As a result of our study, paracervical block is a safe method to use in premenopausal patients to prevent pain during saline infusion sonography.

6. sciencedirect.com sciencedirect.com/science/article/pii/S0010782424001021

Analgesia efficacy of lidocaine transfused by a novel ... Injecting lidocaine into the novel disposable injectable cervical dilator for cervix dilation can significantly reduce pain during an IUD removal.

7. withpower.com withpower.com/trial/phase-4-pain-during-saline-infusion-sonogram-6-2025-876ba

Lidocaine for Pain Reduction in Saline Infusion Sonograms This Phase 4 medical study run by Montefiore Medical Center is evaluating whether Lidocaine will have tolerable side effects & efficacy for patients with ...