Trial · NCT07048769
Paracervical Block for Pain Reduction in Saline Infusion Sonograms
NCT07048769, Phase 4, Recruiting, Montefiore Medical Center
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Paracervical Block for Pain Reduction in Saline Infusion Sonograms. Trials, record NCT07048769. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07048769
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Paracervical Block for Pain Reduction in Saline Infusion Sonograms
- NCT number
- NCT07048769
- Status
- Recruiting
- Phases
- Phase 4
- Enrollment
- 246 participants, estimated
- Lead sponsor
- Montefiore Medical Center
- Conditions
- Pain During Saline Infusion Sonogram
- Interventions
- Lidocaine, Sham paracervical block
- First posted
- 2025-07-02
- Last updated
- 2026-07-09
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in pain intensity from baseline during tubal patency assessment | 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. |
| Secondary | Pain intensity during paracervical block administration | This will be obtained during the procedure, usually within 10 minutes of procedure start. | 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. |
| Secondary | Pain intensity during balloon catheter placement | This will be obtained during the procedure, typically within 10 minutes of procedure start | 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. |
| Secondary | Pain intensity during saline infusion for uterine cavity assessment | This will be obtained during the procedure, within 30 minutes of procedure start | 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. |
| Secondary | Pain intensity upon completion of the procedure | This will be obtained during the procedure, typically within 30 minutes of procedure start | 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. |
| Secondary | Pain intensity 1 hour after procedure | Approximately 1 hour following the 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. |
| Secondary | Percentage of patients not able to receive the paracervical block | This will be determined on day of procedure, typically within 10 minutes of procedure start | 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. |
| Secondary | Percentage of patients requiring tenaculum for catheter insertion | This will be obtained during the procedure, typically within 10 minutes of procedure start | 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. |
| Secondary | Percentage of patients for whom uterine sound was used to complete the saline ultrasound | This will be collected during the procedure, within 30 minutes of procedure start | 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. |
| Other | Patient satisfaction with pain control method | Within 1 hour of procedure completion | Patients will complete a survey within 1 hour of procedure completion asking if they would choose the same pain control method again, with options of "yes", "no" and "unsure". Responses will be summarized and analyzed using basic descriptive statistics. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers10
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07048769
GET https://conductscience.org/api/trials/v1/NCT07048769/registered