Pain During Saline Infusion SonogramPhase 4NCT07048769
Paracervical Block for Pain Reduction in Saline Infusion Sonograms
A Phase 4 study testing Lidocaine in people with Pain During Saline Infusion Sonogram, run by Montefiore Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Pain During Saline Infusion Sonogram
- What is being tested?
- Lidocaine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 246 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Jul 2025to Jul 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Montefiore's Institute for Reproductive Medicine and Health
Hartsdale, New York, 10530
Julian Gingold, MD PhD, 914-997-1060, jgingold@montefiore.org
Julian Gingold, MD, PhD
About this study
Official title: Paracervical Block for Saline Infusion Sonogram in Fertility Evaluation: A Randomized Controlled Trial
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.
Read the detailed 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 recommendations. Women, similarly, may avoid other elective gynecologic procedures, such as intrauterine device placement or saline infusion sonograms, out of fear of pain during the procedure.
Recent evidence has found that local anesthesia can significantly reduce pain during certain procedures, such as surgical abortion and intrauterine device placement (IUD). For example, in two randomized controlled trials of nulliparous women undergoing intrauterine device placement, a 10-20cc buffered 1% lidocaine paracervical block decreased pain during and following IUD placement. However, this reduction in pain may not be significant in multiparous women-in systematic review and meta-analysis of randomized clinical trials (RCTs) of pain management options for women undergoing IUD placement, paracervical blocks were not found to reduce pain in a statistically significant fashion. In women undergoing surgical abortion, a 20cc 1% lidocaine injection significantly reduced pain during dilation and aspiration regardless of parity status.
In reproductive endocrinology and infertility offices, saline infusion sonogram is often performed in the evaluation of uterine cavity and patency of the fallopian tubes. This is a procedure that is demonstrated to cause mild to moderate pain in most patients. These procedures do not standardly receive any local anesthesia, though many practices will recommend an over-the-counter nonsteroidal anti-inflammatory drug (NSAID) prior to procedure. Although no previous study has been published on NSAIDs specifically, a prospective observational study did find that pre-medication of paracetamol + codeine prior to saline ultrasound assessment of uterine cavity and tubal patency significantly reduced pain.
While local anesthesia is not routinely offered during these saline infusion sonograms, several studies have investigated its potential effect. One randomized controlled trial assessed the pain relief effect of topical and intrauterine lidocaine during saline ultrasound, and found no difference in pain compared to placebo. Of note, these saline ultrasounds were only for cavity evaluation, not tubal evaluation, and therefore did not utilize a balloon catheter. Another randomized controlled trial of 96 Turkish women found that paracervical block significantly reduced pain during saline infusion sonogram compared to the placebo group. However, of note, this protocol utilized a tenaculum, which is not routinely used in saline infusion sonograms in the United States for fertility evaluation. Additionally, the catheter diameter used was wider than is used in the clinic (4mm versus 1.67mm). This study also did not appear to evaluate for tubal patency, as the catheter described was not a balloon catheter.
In this study, the investigators aim to add to the existing literature on pain management during saline infusion sonograms to determine if lidocaine paracervical blocks decrease perceived pain in saline ultrasounds that assess for uterine cavity and tubal patency. This will be accomplished by determining if paracervical block provides clinically significant pain relief compared to no anesthesia during saline ultrasound evaluation of uterine cavity and tubal patency.
- Conditions
- Pain During Saline Infusion Sonogram
- Being tested
- Lidocaine, Sham paracervical block
- Keywords
- paracervical block, saline infusion sonogram, Fertility evaluation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LidocaineDrug
10cc of 1% lidocaine buffered with 1cc 8.4% sodium bicarbonate, injected at 4 and 8 o'clock paracervical positions.
Sham paracervical blockProcedure or surgery
A capped needle is pressed at 4 and 8 o'clock positions to mimic lidocaine block without injection.
| Study group | Role | What they receive |
|---|---|---|
| Paracervical Block Arm | Experimental | Participants receive a paracervical block with 10cc 1% lidocaine buffered with 1cc sodium bicarbonate Receives: Drug: Lidocaine |
| Control Arm (No Block) | Placebo comparator | Participants receive no anesthesia; a capped needle is pressed at the paracervical locations to mimic injection Receives: Procedure: Sham paracervical block |
What is being measured
The primary outcome is the main question the study is designed to answer.
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: Measured during the procedure, within 30 minutes of procedure start
Secondary outcomes (8)
Pain intensity during paracervical block administration
Pain intensity during paracervical block administration 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 measured at the time of paracervical block injection or needle pressure. Results will be summarized by study arm and analyzed using basic descriptive statistics.
Measured: This will be obtained during the procedure, usually within 10 minutes of procedure start.
Pain intensity during balloon catheter placement
Pain intensity during balloon catheter placement 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 balloon catheter placement. Results will be summarized by study arm and analyzed using basic descriptive statistics.
Measured: This will be obtained during the procedure, typically within 10 minutes of procedure start
Pain intensity during saline infusion for uterine cavity assessment
Pain intensity during saline infusion for uterine cavity 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 uterine cavity assessment. Results will be summarized by study arm and analyzed using basic descriptive statistics.
Measured: This will be obtained during the procedure, within 30 minutes of procedure start
Pain intensity upon completion of the procedure
Pain intensity 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 procedure completion. Results will be summarized by study arm and analyzed using basic descriptive statistics.
Measured: This will be obtained during the procedure, typically within 30 minutes of procedure start
Pain intensity 1 hour after procedure
Pain intensity following the procedure 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 1 hour after procedure completion. Results will be summarized by study arm and analyzed using basic descriptive statistics.
Measured: Approximately 1 hour following the procedure
Percentage of patients not able to receive the paracervical block
Paracervical blocks sometimes cannot be completed due to anatomic challenges If patients in the lidocaine intervention group are not able to receive the paracervical block due to anatomical challenges, this will be recorded. The percentage of patients who are not able to receive the paracervical block will be summarized using basic descriptive statistics.
Measured: This will be determined on day of procedure, typically within 10 minutes of procedure start
Percentage of patients requiring tenaculum for catheter insertion
Some patients require tenaculum (a metal two-prong grasper) placement on the cervix in order the for the balloon catheter of the saline infusion sonogram to be inserted into the uterine cavity. Whether a tenaculum was used will be recorded. The percentage of participants for whom tenaculum was used to facilitate catheter placement will be summarized using basic descriptive statistics.
Measured: This will be obtained during the procedure, typically within 10 minutes of procedure start
Percentage of patients for whom uterine sound was used to complete the saline ultrasound
Some patients for whom there is initial difficulty in entering the uterine cavity with a balloon catheter require use of a uterine sound to map the cervical canal prior to placing the balloon catheter. The percentage of patients for whom a uterine sound is used will be recorded and analyzed using basic descriptive statistics.
Measured: This will be collected during the procedure, within 30 minutes of procedure start
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2025
- Study start2 Jul 2025
- Primary completionJul 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Pain During Saline Infusion SonogramStudies of the same condition, open and under way.
- More trials run by Montefiore Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 246 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Montefiore Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Julian Gingold, MD, PhD, Principal investigator, Montefiore Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07048769
- Sponsor's protocol ID
- 2024-16284
- Status last verified
- Jul 2026
- First submitted
- 24 Jun 2025
- Last updated
- 9 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Decisions about IPD sharing will be made after the study's completion. Updates regarding data sharing plans will be provided as they become available.
Publications
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.
PubMed 28913108Yung 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.
PubMed 26434382Ludwin 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.
PubMed 28159714Rogerson 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.
PubMed 12135217Renner 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.
PubMed 22525915Samy 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.
PubMed 30611553Akers 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.
PubMed 28885425Mody 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.
PubMed 30095776Hoyo 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.
PubMed 15917039O'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.
PubMed 34353791Nudson, Rae. Gynecology Has a Pain Problem. The Cut, Jun 1 2022.
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Paracervical Block for Saline Infusion Sonogram in Fertility Evaluation: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07048769
- Acronym / sponsor ID
- 2024-16284
- Conditions
- Pain During Saline Infusion Sonogram
- Keywords
- paracervical block, saline infusion sonogram, Fertility evaluation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 246 participants (estimated)
- Lead sponsor
- Montefiore Medical CenterUniversity, hospital or other
- Study start
- 2 Jul 2025 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 2 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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 recommendations. Women, similarly, may avoid other elective gynecologic procedures, such as intrauterine device placement or saline infusion sonograms, out of fear of pain during the procedure.
Recent evidence has found that local anesthesia can significantly reduce pain during certain procedures, such as surgical abortion and intrauterine device placement (IUD). For example, in two randomized controlled trials of nulliparous women undergoing intrauterine device placement, a 10-20cc buffered 1% lidocaine paracervical block decreased pain during and following IUD placement. However, this reduction in pain may not be significant in multiparous women-in systematic review and meta-analysis of randomized clinical trials (RCTs) of pain management options for women undergoing IUD placement, paracervical blocks were not found to reduce pain in a statistically significant fashion. In women undergoing surgical abortion, a 20cc 1% lidocaine injection significantly reduced pain during dilation and aspiration regardless of parity status.
In reproductive endocrinology and infertility offices, saline infusion sonogram is often performed in the evaluation of uterine cavity and patency of the fallopian tubes. This is a procedure that is demonstrated to cause mild to moderate pain in most patients. These procedures do not standardly receive any local anesthesia, though many practices will recommend an over-the-counter nonsteroidal anti-inflammatory drug (NSAID) prior to procedure. Although no previous study has been published on NSAIDs specifically, a prospective observational study did find that pre-medication of paracetamol + codeine prior to saline ultrasound assessment of uterine cavity and tubal patency significantly reduced pain.
While local anesthesia is not routinely offered during these saline infusion sonograms, several studies have investigated its potential effect. One randomized controlled trial assessed the pain relief effect of topical and intrauterine lidocaine during saline ultrasound, and found no difference in pain compared to placebo. Of note, these saline ultrasounds were only for cavity evaluation, not tubal evaluation, and therefore did not utilize a balloon catheter. Another randomized controlled trial of 96 Turkish women found that paracervical block significantly reduced pain during saline infusion sonogram compared to the placebo group. However, of note, this protocol utilized a tenaculum, which is not routinely used in saline infusion sonograms in the United States for fertility evaluation. Additionally, the catheter diameter used was wider than is used in the clinic (4mm versus 1.67mm). This study also did not appear to evaluate for tubal patency, as the catheter described was not a balloon catheter.
In this study, the investigators aim to add to the existing literature on pain management during saline infusion sonograms to determine if lidocaine paracervical blocks decrease perceived pain in saline ultrasounds that assess for uterine cavity and tubal patency. This will be accomplished by determining if paracervical block provides clinically significant pain relief compared to no anesthesia during saline ultrasound evaluation of uterine cavity and tubal patency.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Paracervical Block Arm | Experimental | Drug: LidocaineParticipants receive a paracervical block with 10cc 1% lidocaine buffered with 1cc sodium bicarbonate |
| Control Arm (No Block) | Placebo comparator | Procedure: Sham paracervical blockParticipants receive no anesthesia; a capped needle is pressed at the paracervical locations to mimic injection |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lidocaine10cc of 1% lidocaine buffered with 1cc 8.4% sodium bicarbonate, injected at 4 and 8 o'clock paracervical positions. | Drug | Paracervical Block Arm |
| Sham paracervical blockA capped needle is pressed at 4 and 8 o'clock positions to mimic lidocaine block without injection. | Procedure or surgery | Control Arm (No Block) |
Primary outcome
Change in pain intensity from baseline during tubal patency assessment
Time frame: Measured during the procedure, within 30 minutes of procedure start
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.
8 secondary outcomes
Pain intensity during paracervical block administration
Time frame: This will be obtained during the procedure, usually within 10 minutes of procedure start.
Pain intensity during balloon catheter placement
Time frame: This will be obtained during the procedure, typically within 10 minutes of procedure start
Pain intensity during saline infusion for uterine cavity assessment
Time frame: This will be obtained during the procedure, within 30 minutes of procedure start
Pain intensity upon completion of the procedure
Time frame: This will be obtained during the procedure, typically within 30 minutes of procedure start
Pain intensity 1 hour after procedure
Time frame: Approximately 1 hour following the procedure
Percentage of patients not able to receive the paracervical block
Time frame: This will be determined on day of procedure, typically within 10 minutes of procedure start
Percentage of patients requiring tenaculum for catheter insertion
Time frame: This will be obtained during the procedure, typically within 10 minutes of procedure start
Percentage of patients for whom uterine sound was used to complete the saline ultrasound
Time frame: This will be collected during the procedure, within 30 minutes of procedure start
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2026.
- Background: PubMed 28913108Ozkan 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: PubMed 26434382Yung 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: PubMed 28159714Ludwin 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: PubMed 12135217Rogerson 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: PubMed 22525915Renner 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: PubMed 30611553Samy 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: PubMed 28885425Akers 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: PubMed 30095776Mody 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: PubMed 15917039Hoyo 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: PubMed 34353791O'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.
- BackgroundNudson, Rae. Gynecology Has a Pain Problem. The Cut, Jun 1 2022.
- Individual participant dataSharing planned: Undecided. Decisions about IPD sharing will be made after the study's completion. Updates regarding data sharing plans will be provided as they become available.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Julian Gingold, MD, PhD principal investigator
Montefiore Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Lidocaine in people with Pain During Saline Infusion Sonogram, run by Montefiore Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Meaghan Jain, MD (781-439-5947, mejain@montefiore.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in pain intensity from baseline during tubal patency assessment (time frame: Measured during the procedure, within 30 minutes of procedure start). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07048769, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2026.