Buffered versus unbuffered lidocaine paracervical block to reduce pain and measure clinician empathy during IUD placement.
Official title: Expanding the Use of Paracervical Block for IUD Placements and Adding a Compassionate Care Assessment
Run by University of California, San Diego · NCT06960317 · Data updated 2026-11-12
This will see if buffered or unbuffered lidocaine injections, with or without topical numbing gel, reduce pain and change how much empathy patients feel from clinicians during IUD placement for people aged 18–50 getting an IUD.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 50 Years |
| Sex | Women only |
| Enrollment | 204 (estimated) |
| Sponsor | University of California, San Diego Academic / other |
| Locations | 1 site (La Jolla, California) |
| Status | Recruiting |
| Started | June 4, 2025 |
| Main results expected | June 30, 2027 |
| Study ends | June 30, 2028 |
| Registry record updated | June 13, 2025 |
| Trial ID | NCT06960317 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
People aged 18–50 who are English-speaking, seeking an IUD for contraception or heavy bleeding, have a history of vaginal delivery, can provide informed consent, and do not have pregnancy, chronic pain, current prescription pain medication use, substance use history, prior IUD placement, or allergies to the anesthetic are eligible.
✕Probably not a fit
People who are pregnant, have chronic pain or a history of substance use, use prescription pain medications, have no prior vaginal delivery, have known allergies to anesthetic components, or have contraindications to IUDs may not receive benefit from this protocol.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
At the UC San Diego clinic, participants undergoing IUD placement will receive one of the paracervical approaches (buffered lidocaine, unbuffered lidocaine, or a sham/comparator) and may also receive topical lidocaine gel. During the local anesthetic administration and IUD placement, participants complete brief questionnaires about pain, satisfaction, and perceived clinician empathy. The trial enrolls adults 18–50 who can consent, speak English, and do not have chronic pain, substance use, pregnancy, or contraindications to local anesthetic or IUD. Outcomes compare pain scores and empathy/satisfaction measures between the different anesthetic approaches.
Why it matters
Potential benefit: If successful, this approach could lower pain during IUD placement and improve patient comfort and perceived clinician empathy.
How similar studies have gone: Buffered lidocaine and paracervical blocks have been used successfully to reduce pain in other gynecologic procedures, though combining these comparisons with formal measurement of clinician empathy during IUD placement is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
University of California, San Diego
La Jolla, California, United States Recruiting
Study contacts
- Principal investigator: Sheila K Mody, MD, MPH — UC San Diego
- Study coordinator: Marisa Hildebrand, MPH
- Email: mchildeb@health.ucsd.edu
- Phone: (858) 657-8745
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Effectiveness of the Natural Cycles birth control app
This study will test how well the Natural Cycles app prevents pregnancy over one year in sexually active women aged 18 to 35 with no known infertility.
-
SAM aluminium splint for suspected wrist fractures
This study will see if adding a SAM aluminium splint to usual care reduces pain for people with suspected wrist fractures who come to the emergency department.
-
Female Reproductive Health in the Canadian Armed Forces: Understanding Issues from Contraception to Pelvic Floor Dysfunction
This observational study looks at reproductive health among women in the Canadian Armed Forces to see how contraception, pregnancy outcomes, infertility, pelvic floor issues, and related factors affect service members and veterans.
-
Long-acting HIV PrEP and contraception PK study in AGYW
This study tests how long-acting cabotegravir for PrEP interacts with hormonal contraception in young women.
-
Vasectomy: Right for Me? — a web-based decision aid
A web-based decision aid helps men think clearly about vasectomy and other birth control options to see if it fits their goals.
-
Combined acupressure to reduce post-thoracotomy pain and improve lung volume
This trial will try combined acupressure on patients after thoracotomy to see if it reduces postoperative pain and helps restore lung volume.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.