Paracervical Block for Pain Reduction in Saline Infusion Sonograms

NCT07048769 | Recruiting Phase 4 DMC FDA Drug

• 1 other identifier: 2024-16284
• Study Type: interventional
• Target: 246
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain During Saline Infusion Sonogram

Keywords

paracervical block; saline infusion sonogram; Fertility evaluation

Outcome Measures

Primary Outcomes (1)

• Change in pain intensity from baseline during tubal patency assessment

  Pain intensity during tubal patency assessment will be assessed using a Visual Analog Scale (VAS) ranging from 0 to 100 mm, where 0 represents "no pain" and 100 represents "worst possible pain." The VAS score will be recorded at the time of saline infusion sonogram assessing tubal patency. The pain intensity will be evaluated as a change from their baseline level of pain. Results will be summarized by study arm and analyzed using basic descriptive statistics.

  Measured during the procedure, within 30 minutes of procedure start

Secondary Outcomes (8)

• Pain intensity during paracervical block administration

  This will be obtained during the procedure, usually within 10 minutes of procedure start.

• Pain intensity during balloon catheter placement

  This will be obtained during the procedure, typically within 10 minutes of procedure start

• Pain intensity during saline infusion for uterine cavity assessment

  This will be obtained during the procedure, within 30 minutes of procedure start

• Pain intensity upon completion of the procedure

  This will be obtained during the procedure, typically within 30 minutes of procedure start

• Pain intensity 1 hour after procedure

  Approximately 1 hour following the procedure

Other Outcomes (1)

• Patient satisfaction with pain control method

  Within 1 hour of procedure completion

Study Arms (2)

Paracervical Block Arm

EXPERIMENTAL

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

Drug: Lidocaine

Control Arm (No Block)

PLACEBO COMPARATOR

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

Procedure: Sham paracervical block

Interventions

Lidocaine DRUG

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

Paracervical Block Arm

Sham paracervical block PROCEDURE

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

Control Arm (No Block)

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Montefiore Medical Center: lead

Study Sites (1)

Montefiore's Institute for Reproductive Medicine and Health

Hartsdale, New York, 10530, United States

RECRUITING

Related Publications (11)

• 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.

  PMID: 28913108 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.

  PMID: 26434382 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.

  PMID: 28159714 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.

  PMID: 12135217 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.

  PMID: 22525915 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.

  PMID: 30611553 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.

  PMID: 28885425 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.

  PMID: 30095776 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.

  PMID: 15917039 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.

  PMID: 34353791 BACKGROUND

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

  BACKGROUND

MeSH Terms

Interventions

Lidocaine

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Julian Gingold, MD, PhD

  Montefiore Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Meaghan Jain, MD

CONTACT

781-439-5947; mejain@montefiore.org

Julian Gingold, MD, PhD

CONTACT

914-997-1060; jgingold@montefiore.org

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants are randomized in a 1:1 ratio to receive either a lidocaine paracervical block or no anesthesia during saline infusion sonogram. Each participant receives only one intervention.

Study Record Dates

• First Submitted: June 24, 2025
• First Posted: July 2, 2025
• Study Start: July 2, 2025
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: July 9, 2026

Record last verified: 2026-07

Locations

US (1)