Paracervical block to reduce pain during saline infusion sonogram
Paracervical Block for Saline Infusion Sonogram in Fertility Evaluation: A Randomized Controlled Trial
This trial will test whether a lidocaine paracervical block reduces pain for women undergoing saline infusion sonograms during fertility evaluations.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 246 (estimated) |
| Ages | 18 Years to 50 Years |
| Sex | Female |
| Sponsor | Montefiore Medical Center Academic / other |
| Locations | 1 site (Hartsdale, New York) |
| Trial ID | NCT07048769 on ClinicalTrials.gov |
What this trial studies
In this randomized Phase 4 trial, 246 women having saline infusion sonograms with a balloon catheter for tubal patency at Montefiore will be assigned to receive either a lidocaine paracervical block or a sham procedure (capped needle pressed against the cervix). All participants are asked to take 600–800 mg ibuprofen 30 minutes to 4 hours before the procedure and will report pain scores at several points during and after the SIS. The investigators will compare self-reported pain ratings between groups to see if local anesthesia lowers procedural pain. Eligible participants must be able to consent in English or Spanish and have no known lidocaine allergy or other exclusion criteria.
Who should consider this trial
Good fit: Women undergoing uterine cavity and tubal patency evaluation via saline infusion sonogram with a balloon catheter at Montefiore who can consent in English or Spanish, have taken 600–800 mg ibuprofen beforehand, and do not have a lidocaine allergy.
Not a fit: Patients having uterine-only evaluations, those who did not take the required ibuprofen pre-medication, or anyone with a known lidocaine allergy may not receive benefit from this intervention.
Why it matters
Potential benefit: If successful, this could reduce pain during SIS and make fertility evaluations more comfortable and less likely to be avoided.
How similar studies have performed: Similar paracervical or local anesthesia approaches have reduced pain for procedures like IUD placement and surgical abortion, but evidence for use during saline infusion sonograms is limited and mixed.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Hartsdale, New York
- Montefiore's Institute for Reproductive Medicine and Health — Hartsdale, New York, United States (Recruiting)
Study contacts
- Principal investigator: Julian Gingold, MD, PhD — Montefiore Medical Center
- Study coordinator: Meaghan Jain, MD
- Email: mejain@montefiore.org
- Phone: 781-439-5947
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.