IUD Insertion PainPhase 4NCT06951191
Intrauterine Device Insertion Pain Management
A Phase 4 study testing Benzocaine 20%, Lidocaine 2% and Saline 0.9% in people with IUD Insertion Pain and IUD Insertion, run by University of Missouri-Columbia at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- IUD Insertion Pain, IUD Insertion
- What is being tested?
- Benzocaine 20%, Lidocaine 2% and Saline 0.9%
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Jun 2025to 15 Apr 2026
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 years of age or older
- Undergoing IUD insertion
Who cannot join
- IUD insertion <6 weeks postpartum
- Age <18 years
- Allergy or history of adverse effect of lidocaine, benzocaine (and inactive ingredients: flavor, isobutane, propane, polyethylene glycol, sodium saccharin), or ibuprofen
- Not undergoing IUD insertion
- Undergoing IUD insertion under general anesthesia
- Usage of anti-inflammatory or as-needed anxiety medications (not daily use) in the 12 hours prior to IUD insertion
Trial locations and contacts
1 site in 1 country.
United States1 site
Missouri OB/GYN Associates-Smiley Lane
Columbia, Missouri, 65202
About this study
Official title: Applying a New Method for Pain Control in Intrauterine Device Insertion
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?
Read more
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
Read the detailed description
The goal of the researchers is to determine if use of a topical benzocaine spray prior to lidocaine injection will cause a significant reduction in pain experienced by patients undergoing an IUD insertion. Participants will be screened, approached, and fully consented by research staff in the clinic prior to their IUD insertion. Demographics will be gathered from all participants through a questionnaire. All participants will be given 600mg of ibuprofen prior to the procedure, but will be randomized into one of 4 groups as to what interventions/placebos they will receive during their insertion. Interventions studied are benzocaine spray and lidocaine injection. Placebos will be saline spray and paracervical needle stick without injection. Participants will be asked to rate their pain on a visual scale of 1-10 at the following timepoints during the procedure:
- At the time of tenaculum placement
- At the time of uterine sounding
- At the time of IUD insertion and deployment
- Immediately after removal of instrumentation
- 15 minutes after the procedure Participants who provided an email will be sent an additional questionnaire to be responded to within 24 hours of the procedure. At the conclusion of the trial statistical analysis will be done to determine significance of pain reduction varying between the 4 groups.
- Conditions
- IUD Insertion Pain, IUD Insertion
- Being tested
- Benzocaine 20%, Lidocaine 2%, Sham injection, Saline 0.9%
- Keywords
- IUD, IUD insertion, IUD insertion pain, benzocaine, paracervical lidocaine, paracervical block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Benzocaine 20%Drug
Benzocaine 20% topical spray
Lidocaine 2%Drug
Lidocaine 2% injectable solution
Sham injectionOther
Sham injection to mimic Lidocaine paracervical block. Will use an injection needle and sham inject (no actual injection of fluid)
Saline 0.9%Drug
Saline spray to mimic use of benzocaine spray
| Study group | Role | What they receive |
|---|---|---|
| Placebo/Placebo | Placebo comparator | Participants in this arm will receive saline spray and a needle stick without injection to the cervix Receives: Other: Sham injection; Drug: Saline 0.9% |
| Placebo/Lidocaine | Experimental | Participants in this arm will receive saline spray and injected lidocaine to the cervix Receives: Drug: Lidocaine 2%; Drug: Saline 0.9% |
| Benzocaine/Placebo | Experimental | Participants in this arm will receive benzocaine spray and a needle stick without injection to the cervix Receives: Drug: Benzocaine 20%; Other: Sham injection |
| Benzocaine/Lidocaine | Experimental | Participants in this arm will receive benzocaine spray and lidocaine injection to the cervix Receives: Drug: Benzocaine 20%; Drug: Lidocaine 2% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Pain Score During IUD Insertion Events as Quantified by Visual Analogue Scale
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).
Measured: During IUD insertion procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2025
- Study start23 Jun 2025
- Primary completion15 Apr 2026
- Study completion15 Apr 2026
Why it stopped: Inadequate recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IUD Insertion PainStudies of the same condition, open and under way.
- 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
- Factorial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Missouri-Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kirby Woodall, University of Missouri-Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06951191
- Sponsor's protocol ID
- 2101465
- Status last verified
- Apr 2026
- First submitted
- 22 Apr 2025
- Last updated
- 21 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study Arm, Age, Parity, and Pain-scoring at different intervals
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Applying a New Method for Pain Control in Intrauterine Device Insertion
- ClinicalTrials.gov ID
- NCT06951191
- Acronym / sponsor ID
- 2101465
- Conditions
- IUD Insertion Pain, IUD Insertion
- Keywords
- IUD, IUD insertion, IUD insertion pain, benzocaine, paracervical lidocaine, paracervical block
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Inadequate recruitment
- Enrolment
- 1 participants (actual)
- Lead sponsor
- University of Missouri-ColumbiaUniversity, hospital or other
- Study start
- 23 Jun 2025 (actual)
- Primary completion
- 15 Apr 2026 (actual)
- Study completion
- 15 Apr 2026 (actual)
- First posted
- 30 Apr 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.
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
Detailed description
The goal of the researchers is to determine if use of a topical benzocaine spray prior to lidocaine injection will cause a significant reduction in pain experienced by patients undergoing an IUD insertion. Participants will be screened, approached, and fully consented by research staff in the clinic prior to their IUD insertion. Demographics will be gathered from all participants through a questionnaire. All participants will be given 600mg of ibuprofen prior to the procedure, but will be randomized into one of 4 groups as to what interventions/placebos they will receive during their insertion. Interventions studied are benzocaine spray and lidocaine injection. Placebos will be saline spray and paracervical needle stick without injection. Participants will be asked to rate their pain on a visual scale of 1-10 at the following timepoints during the procedure:
- At the time of tenaculum placement
- At the time of uterine sounding
- At the time of IUD insertion and deployment
- Immediately after removal of instrumentation
- 15 minutes after the procedure Participants who provided an email will be sent an additional questionnaire to be responded to within 24 hours of the procedure. At the conclusion of the trial statistical analysis will be done to determine significance of pain reduction varying between the 4 groups.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Placebo/Placebo | Placebo comparator | Other: Sham injection, Drug: Saline 0.9%Participants in this arm will receive saline spray and a needle stick without injection to the cervix |
| Placebo/Lidocaine | Experimental | Drug: Lidocaine 2%, Drug: Saline 0.9%Participants in this arm will receive saline spray and injected lidocaine to the cervix |
| Benzocaine/Placebo | Experimental | Drug: Benzocaine 20%, Other: Sham injectionParticipants in this arm will receive benzocaine spray and a needle stick without injection to the cervix |
| Benzocaine/Lidocaine | Experimental | Drug: Benzocaine 20%, Drug: Lidocaine 2%Participants in this arm will receive benzocaine spray and lidocaine injection to the cervix |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 18 years of age or older
- Undergoing IUD insertion
Key exclusion criteria (6 listed)
- IUD insertion <6 weeks postpartum
- Age <18 years
- Allergy or history of adverse effect of lidocaine, benzocaine (and inactive ingredients: flavor, isobutane, propane, polyethylene glycol, sodium saccharin), or ibuprofen
- Not undergoing IUD insertion
- Undergoing IUD insertion under general anesthesia
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 |
|---|---|---|
| Benzocaine 20%Benzocaine 20% topical spray | Drug | Benzocaine/Lidocaine, Benzocaine/Placebo |
| Lidocaine 2%Lidocaine 2% injectable solution | Drug | Benzocaine/Lidocaine, Placebo/Lidocaine |
| Sham injectionSham injection to mimic Lidocaine paracervical block. Will use an injection needle and sham inject (no actual injection of fluid) | Other | Benzocaine/Placebo, Placebo/Placebo |
| Saline 0.9%Saline spray to mimic use of benzocaine spray | Drug | Placebo/Lidocaine, Placebo/Placebo |
Primary outcome
Mean Pain Score During IUD Insertion Events as Quantified by Visual Analogue Scale
Time frame: During IUD insertion procedure
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).
Results and safety
The study was stopped early (reason given: Inadequate recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2026.
- Individual participant dataSharing planned: Yes. Study Arm, Age, Parity, and Pain-scoring at different intervals
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Benzocaine 20%, Lidocaine 2% and Saline 0.9% in people with IUD Insertion Pain and IUD Insertion, run by University of Missouri-Columbia 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 2 inclusion and 6 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: stopped early, as of the sponsor's last update on 21 Apr 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?
The study was stopped early (reason given: Inadequate recruitment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Pain Score During IUD Insertion Events as Quantified by Visual Analogue Scale (time frame: During IUD insertion procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Apr 2026.