NCT06960317 Empathy Through Pain Control: Lidocaine Paracervical Block for IUD Placements
| NCT ID | NCT06960317 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of California, San Diego |
| Condition | Contraception |
| Study Type | INTERVENTIONAL |
| Enrollment | 204 participants |
| Start Date | 2025-06-04 |
| Primary Completion | 2027-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 204 participants in total. It began in 2025-06-04 with a primary completion date of 2027-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The goal of this research study is to learn more about how different uses of a numbing medication might affect pain levels while getting an IUD placed. The investigators are also studying participants opinions of their clinicians' empathy. The investigators are inviting patients who arrive at their clinic visit seeking an IUD. Usually, at University of California, San Diego (UCSD), for patients who have never delivered a baby, clinicians use a buffered paracervical block for before IUD placement. The purpose of this research study is to investigate whether a "buffered" (2 cc of sodium bicarbonate, 18 cc of 1% lidocaine) paracervical block (numbing medication given on both sides of the cervix) is effective in reducing pain during IUD placement in individuals with prior C-sections, the difference between buffered and unbuffered for nulliparous patients, and whether a medicated gel reduces pain with the paracervical block.
Eligibility Criteria
Inclusion Criteria: 1. Ability to provide informed consent 2. Women IUD placement for contraception or heavy menstrual bleeding 3. Ages 18-50 4. English-speaking 5. Participants must not have a past medical history of substance use disorders, pain disorders, use of prescription pain medications or are found to be pregnant Exclusion Criteria: 1. No history of vaginal delivery 2. Current use of prescription pain medication prior to procedure. Over-the-counter medications such as those containing ibuprofen, aspirin, acetaminophen, or naproxen are allowed. 3. Diagnosed chronic pain condition 4. Current pregnancy 5. Known allergic reactions to components of the local anesthetic 6. History of an IUD placement 7. Current substance use or history of substance use 8. Known contraindications to IUD, such as unexplained vaginal bleeding
Contact & Investigator
Sheila K Mody, MD, MPH
PRINCIPAL INVESTIGATOR
UC San Diego
Frequently Asked Questions
Who can join the NCT06960317 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 50 Years, studying Contraception. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06960317 currently recruiting?
Yes, NCT06960317 is actively recruiting participants. Contact the research team at mchildeb@health.ucsd.edu for enrollment information.
Where is the NCT06960317 trial being conducted?
This trial is being conducted at La Jolla, United States.
Who is sponsoring the NCT06960317 clinical trial?
NCT06960317 is sponsored by University of California, San Diego. The principal investigator is Sheila K Mody, MD, MPH at UC San Diego. The trial plans to enroll 204 participants.