Paracervical Block for Pain Reduction in Saline Infusion Sonograms

NCT ID: NCT07048769

Last Updated: 2025-07-04

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 246 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-02
• Study Completion Date: 2026-07-31

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.

Detailed Description

Pain management options (or lack thereof) during routine gynecologic procedures has become a women's health concern with growing prominence. Patients increasingly are reporting their "excruciating" pain experiences from gynecologic procedures ranging from pap smears to intrauterine device placements. When pain during gynecologic procedures is not well managed, gynecologic care quality and frequency suffers - one study found that in a group of middle-aged black women, those who perceived pap smears to be painful were almost five times more likely to not adhere to regular pap screening recommendations. Women, similarly, may avoid other elective gynecologic procedures, such as intrauterine device placement or saline infusion sonograms, out of fear of pain during the procedure.

Recent evidence has found that local anesthesia can significantly reduce pain during certain procedures, such as surgical abortion and intrauterine device placement (IUD). For example, in two randomized controlled trials of nulliparous women undergoing intrauterine device placement, a 10-20cc buffered 1% lidocaine paracervical block decreased pain during and following IUD placement. However, this reduction in pain may not be significant in multiparous women-in systematic review and meta-analysis of randomized clinical trials (RCTs) of pain management options for women undergoing IUD placement, paracervical blocks were not found to reduce pain in a statistically significant fashion. In women undergoing surgical abortion, a 20cc 1% lidocaine injection significantly reduced pain during dilation and aspiration regardless of parity status.

In reproductive endocrinology and infertility offices, saline infusion sonogram is often performed in the evaluation of uterine cavity and patency of the fallopian tubes. This is a procedure that is demonstrated to cause mild to moderate pain in most patients. These procedures do not standardly receive any local anesthesia, though many practices will recommend an over-the-counter nonsteroidal anti-inflammatory drug (NSAID) prior to procedure. Although no previous study has been published on NSAIDs specifically, a prospective observational study did find that pre-medication of paracetamol + codeine prior to saline ultrasound assessment of uterine cavity and tubal patency significantly reduced pain.

While local anesthesia is not routinely offered during these saline infusion sonograms, several studies have investigated its potential effect. One randomized controlled trial assessed the pain relief effect of topical and intrauterine lidocaine during saline ultrasound, and found no difference in pain compared to placebo. Of note, these saline ultrasounds were only for cavity evaluation, not tubal evaluation, and therefore did not utilize a balloon catheter. Another randomized controlled trial of 96 Turkish women found that paracervical block significantly reduced pain during saline infusion sonogram compared to the placebo group. However, of note, this protocol utilized a tenaculum, which is not routinely used in saline infusion sonograms in the United States for fertility evaluation. Additionally, the catheter diameter used was wider than is used in the clinic (4mm versus 1.67mm). This study also did not appear to evaluate for tubal patency, as the catheter described was not a balloon catheter.

In this study, the investigators aim to add to the existing literature on pain management during saline infusion sonograms to determine if lidocaine paracervical blocks decrease perceived pain in saline ultrasounds that assess for uterine cavity and tubal patency. This will be accomplished by determining if paracervical block provides clinically significant pain relief compared to no anesthesia during saline ultrasound evaluation of uterine cavity and tubal patency.

Conditions

Pain During Saline Infusion Sonogram

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Paracervical Block Arm

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

Group Type: EXPERIMENTAL

Lidocaine

Intervention Type: DRUG

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

Control Arm (No Block)

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

Group Type: PLACEBO_COMPARATOR

Sham paracervical block

Intervention Type: PROCEDURE

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

Interventions

Lidocaine

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

Intervention Type: DRUG

Sham paracervical block

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

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Montefiore Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Julian Gingold, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Montefiore Medical Center

Locations

Montefiore's Institute for Reproductive Medicine and Health

Hartsdale, New York, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Meaghan Jain, MD

Role: CONTACT

mejain@montefiore.org

781-439-5947

Julian Gingold, MD, PhD

Role: CONTACT

jgingold@montefiore.org

914-997-1060

Facility Contacts

Julian Gingold, MD PhD

Role: primary

jgingold@montefiore.org

914-997-1060

References

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Reference Type: BACKGROUND

PMID: 28913108 (View on PubMed)

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Reference Type: BACKGROUND

PMID: 26434382 (View on PubMed)

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

PMID: 30095776 (View on PubMed)

Hoyo C, Yarnall KS, Skinner CS, Moorman PG, Sellers D, Reid L. Pain predicts non-adherence to pap smear screening among middle-aged African American women. Prev Med. 2005 Aug;41(2):439-45. doi: 10.1016/j.ypmed.2004.11.021.

Reference Type: BACKGROUND

PMID: 15917039 (View on PubMed)

O'Donohue S. The ripples of trauma caused by severe pain during IUD procedures. BMJ. 2021 Aug 5;374:n1910. doi: 10.1136/bmj.n1910. No abstract available.

Reference Type: BACKGROUND

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Nudson, Rae. Gynecology Has a Pain Problem. The Cut, Jun 1 2022.

Reference Type: BACKGROUND

Other Identifiers

2024-16284

Identifier Type: -

Identifier Source: org_study_id