Paracervical Block for Saline Infusion Sonogram in Fertility Evaluation: A Randomized Controlled Trial
Montefiore Medical Center
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.
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 recommend…
Eligibility
- Age range
- 18–50 years
- Sex
- Female
- Healthy volunteers
- No
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
Interventions
- DrugLidocaine
10cc of 1% lidocaine buffered with 1cc 8.4% sodium bicarbonate, injected at 4 and 8 o'clock paracervical positions.
- ProcedureSham paracervical block
A capped needle is pressed at 4 and 8 o'clock positions to mimic lidocaine block without injection.
Location
- Montefiore's Institute for Reproductive Medicine and HealthHartsdale, New York