Buffered versus unbuffered lidocaine paracervical block to reduce pain and measure clinician empathy during IUD placement.
Expanding the Use of Paracervical Block for IUD Placements and Adding a Compassionate Care Assessment
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 204 (estimated) |
| Ages | 18 Years to 50 Years |
| Sex | Female |
| Sponsor | University of California, San Diego Academic / other |
| Locations | 1 site (La Jolla, California) |
| Trial ID | NCT06960317 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
La Jolla, California
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.