The optimal analgesic method in saline infusion sonogram: A comparison of two effective techniques with placebo.
Sadullah Özkan, Bülent Kars, Önder Sakin...
https://pubmed.ncbi.nlm.nih.gov/28913108Actively Recruiting
Led by Montefiore Medical Center · Updated on 2025-07-04
246
Participants Needed
1
Research Sites
N/A
Total Duration
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
Paracervical Block for Pain Reduction in Saline Infusion Sonograms
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Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
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)
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)
Total: 1 location
1
Montefiore's Institute for Reproductive Medicine and Health
Hartsdale, New York, United States, 10530
Actively Recruiting
M
Meaghan Jain, MD
J
Julian Gingold, MD, PhD
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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