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NCT06951191 · ClinicalTrials.gov registry record · Phase 4
Intrauterine Device Insertion Pain Management
A Phase 4 study of IUD Insertion Pain and IUD Insertion, sponsored by University of Missouri-Columbia.
- Recruiting
- Registry status
- Phase 4
- Development phase
- 160
- Enrollment target
- 1
- Study location
NCT06951191: Recruiting Phase 4 study of IUD Insertion Pain and IUD Insertion, sponsored by University of Missouri-Columbia.
NCT06951191 is a Phase 4 study of IUD Insertion Pain and IUD Insertion that is actively recruiting participants, run by University of Missouri-Columbia. The registered enrollment target is 160 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (69% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06951191, a Phase 4 study of IUD Insertion Pain and IUD Insertion, is actively recruiting participants, sponsored by University of Missouri-Columbia.
- RECRUITING
- Registry status
- Phase 4
- Development phase
- 160 participants
- Enrollment target
- 1
- Study location
Study Summary
The goal of this clinical trial is to learn if use of topical benzocaine prior to the injection of lidocaine is effective in decreasing pain experienced during IUD insertion in patients 18 or older. The main question it aims to answer is: Does topical use of benzocaine prior to lidocaine injection during IUD insertion effectively decrease pain experienced? Researchers will compare benzocaine/lidocaine to benzocaine/placebo, placebo/lidocaine, and placebo/placebo to see if use of benzocaine prior to lidocaine injection works more effectively to decrease pain experienced rather than lidocaine, benzocaine, or placebo use alone. Participants will: * Arrive to clinic for previously scheduled IUD insertion * Be screened, approached by research staff, and consented to join the trial * Complete a demographic questionnaire * Be randomly and blindly assigned to one of four groups * Placebo/Placebo * Placebo/Lidocaine * Benzocaine/Placebo * Benzocaine/Lidocaine * All groups will be given 600mg of ibuprofen prior to procedure * Be asked to rate their pain on a visual scale of 1-10 during several distinct points of the procedure. * Be sent an optional survey to their email after the procedure
Primary Outcome
The Visual Analogue Scale (VAS) is a 0-10 pain intensity scale commonly used to assess pain intensity. Scores of 0 represent having no pain at all while scores of 10 represent worst pain possible; Therefore higher scores represent worse outcomes for pain management. VAS will be used to determine participant's levels of experienced pain at the 5 distinct events (tenaculum placement, uterine sounding, IUD insertion/deployment, immediately after instrumentation removal, 15 minutes post-procedure).
Conditions Studied
Interventions
- DRUG Benzocaine 20%
- DRUG Lidocaine 2%
- OTHER Sham injection
- DRUG Saline 0.9%
Study Locations (1)
Missouri
- Missouri OB/GYN Associates-Smiley Lane - Columbia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 160 participants |
| Start Date | 2025-06-23 |
| Est. Completion | 2026-12 |
| Phase | Phase 4 |
What NCT06951191 shows while recruiting
NCT06951191 is an interventional study that assigns participants to a tested intervention. The registered 160 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (69% lower).
The record links to 2 conditions, with IUD Insertion Pain appearing as the primary indexed condition, and to 4 interventions - of which Benzocaine 20% is the first listed.
NCT06951191 reports a single indexed study location in Missouri.
Frequently Asked Questions
What is clinical trial NCT06951191 about?
NCT06951191 is a clinical study titled "Intrauterine Device Insertion Pain Management". The goal of this clinical trial is to learn if use of topical benzocaine prior to the injection of lidocaine is effective in decreasing pain experienced during IUD insertion in patients 18 or older. The main question it aims to answer is: Does topical use of benzocaine prior to lidocaine injection ...
What is the current status of trial NCT06951191?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 160 participants. The study started on 2025-06-23. Estimated completion is 2026-12.
What conditions does trial NCT06951191 study?
This clinical trial studies the following conditions: IUD Insertion Pain, IUD Insertion.
What interventions are being tested in trial NCT06951191?
The interventions under investigation include: Benzocaine 20% (DRUG), Lidocaine 2% (DRUG), Sham injection (OTHER), Saline 0.9% (DRUG).
Who is sponsoring clinical trial NCT06951191?
This trial is sponsored by University of Missouri-Columbia, which has 291 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06951191 being conducted?
This trial has 1 study location across Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06951191's enrollment target sits among peer trials
160 507th of 2000 higher than 1,486 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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