Paracervical Block for Pain Reduction in Saline Infusion Sonograms
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.
Timeline
- Start
- 2025-07-02
- Primary completion
- 2027-07
- Completion
- 2027-07
Publications
- Background Ozkan S, Kars B, Sakin O, Onan Yilmaz A, Bektas YT, Kasikci HO. The optimal analgesic method in saline infusion sonogram: A comparison of two effective techniques with placebo. Turk J Obstet Gynecol. 2016 Sep;13(3):132-136. doi: 10.4274/tjod.46667. Epub 2016 Sep 15.
- Background Yung SS, Lai SF, Lam MT, Lee VC, Li RH, Ho PC, Ng EH. Randomized, controlled, double-blind trial of topical lidocaine gel and intrauterine lidocaine infusion for pain relief during saline contrast sonohysterography. Ultrasound Obstet Gynecol. 2016 Jan;47(1):17-21. doi: 10.1002/uog.15775. Epub 2015 Nov 29.
- Background Ludwin I, Martins WP, Nastri CO, Ludwin A. Pain Intensity During Ultrasound Assessment of Uterine Cavity and Tubal Patency With and Without Painkillers: Prospective Observational Study. J Minim Invasive Gynecol. 2017 May-Jun;24(4):599-608. doi: 10.1016/j.jmig.2017.01.015. Epub 2017 Feb 1.
- Background Rogerson L, Bates J, Weston M, Duffy S. A comparison of outpatient hysteroscopy with saline infusion hysterosonography. BJOG. 2002 Jul;109(7):800-4. doi: 10.1111/j.1471-0528.2002.01478.x.
- Background Renner RM, Nichols MD, Jensen JT, Li H, Edelman AB. Paracervical block for pain control in first-trimester surgical abortion: a randomized controlled trial. Obstet Gynecol. 2012 May;119(5):1030-7. doi: 10.1097/AOG.0b013e318250b13e.
- Background Samy A, Abbas AM, Mahmoud M, Taher A, Awad MH, El Husseiny T, Hussein M, Ramadan M, Shalaby MA, El Sharkawy M, Hatem D, Alaa-El-Din Wali A, Abd-El-Fatah SM, Hussein AH, Haggag H. Evaluating different pain lowering medications during intrauterine device insertion: a systematic review and network meta-analysis. Fertil Steril. 2019 Mar;111(3):553-561.e4. doi: 10.1016/j.fertnstert.2018.11.012. Epub 2019 Jan 2.
- Background Akers AY, Steinway C, Sonalkar S, Perriera LK, Schreiber C, Harding J, Garcia-Espana JF. Reducing Pain During Intrauterine Device Insertion: A Randomized Controlled Trial in Adolescents and Young Women. Obstet Gynecol. 2017 Oct;130(4):795-802. doi: 10.1097/AOG.0000000000002242.
- Background Mody SK, Farala JP, Jimenez B, Nishikawa M, Ngo LL. Paracervical Block for Intrauterine Device Placement Among Nulliparous Women: A Randomized Controlled Trial. Obstet Gynecol. 2018 Sep;132(3):575-582. doi: 10.1097/AOG.0000000000002790.
- Background 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.
- Background 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.
- Background Nudson, Rae. Gynecology Has a Pain Problem. The Cut, Jun 1 2022.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Lidocaine | Other / unclassified | 10 ml | Other |
Indications
No indication recorded.