Empathy Through Pain Control: Lidocaine Paracervical Block for IUD Placements
Purpose
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.
Conditions
- Contraception
- Pain, Acute
- Anesthesia, Local
Eligibility
- Eligible Ages
- Between 18 Years and 50 Years
- Eligible Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- 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
- 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
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Intervention Model Description
- 6-armed single-blind randomized controlled
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
- Masking Description
- Participants will not know their group assignment. The clinicians will know which group the participant is in.
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental 1a: Buffered lidocaine paracervical block |
Treatment group: will receive a 20-mL buffered (2 cc of sodium bicarbonate, 18 cc of 1% lidocaine) paracervical block administered before IUD placement. They will also receive 2 cc of buffered 1% lidocaine at the top of the cervix where the clinician places a tenaculum. |
|
|
Sham Comparator 1b: Capped needle |
Sham group: will receive a capped needle without any medication administered as paracervical block before IUD placement. They will receive 2 cc of buffered 1% lidocaine at the top of the cervix where the clinician places a tenaculum. |
|
|
Experimental 2a: Buffered lidocaine paracervical block |
Treatment group: will receive a 20-mL buffered (2 cc of sodium bicarbonate, 18 cc of 1% lidocaine) paracervical block administered before IUD placement. They will also receive 2 cc of buffered 1% lidocaine at the top of the cervix where the clinician places a tenaculum. |
|
|
Active Comparator 2b: Unbuffered lidocaine paracervical block |
Active comparator group: will receive a 20-mL unbuffered (1% lidocaine) paracervical block administered before IUD placement. They will also receive 2 cc of buffered 1% lidocaine at the top of the cervix where the clinician places a tenaculum. |
|
|
Experimental 3a: Medicated gel |
Treatment group: will receive lidocaine-infused gel prior to administration of paracervical block. |
|
|
Placebo Comparator 3b: Non-medicated gel |
Placebo group: will receive a non-medicated gel prior to administration of paracervical block. |
|
Recruiting Locations
La Jolla, California 92093
More Details
- NCT ID
- NCT06960317
- Status
- Recruiting
- Sponsor
- University of California, San Diego
Detailed Description
Lidocaine is a drug that has been approved by the Food and Drug Administration (FDA). Sodium bicarbonate is an additive that buffers the acidity of lidocaine. The combination of the two is safe and effective as a paracervical block for pain relief in various OBGYN procedures. At UCSD and other places, it is not currently standard practice for people with prior deliveries birth to receive a paracervical block prior to IUD placement. Participants who take part in this study, may receive an injection of buffered lidocaine (2 cc of sodium bicarbonate, 18 cc of 1% lidocaine), an injection of unbuffered block, and/or lidocaine gel. Throughout the local anesthetic and intrauterine device (IUD) placement procedure, research team members will present participants with questionnaires to complete to assess participants' pain, participants' satisfaction with the procedure, and how much empathy participants feel the clinician has shown.