Expanding the Use of Paracervical Block for IUD Placements and Adding a Compassionate Care Assessment
University of California, San Diego
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.
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 unbuf…
Eligibility
- Age range
- 18–50 years
- Sex
- Female
- Healthy volunteers
- Yes
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.…
Interventions
- DrugBuffered Lidocaine
To determine if a 20 cc buffered (2 cc of sodium bicarbonate, 18 cc of 1% lidocaine) lidocaine paracervical block decreases pain with IUD placement
- OtherSham Comparator
None - capped needle will not be injected nor will it contain any medication.
- DrugUnbuffered lidocaine
To determine if a 20 cc unbuffered (1% lidocaine) lidocaine paracervical block decreases pain with IUD placement
- DrugXylocaine jelly 2%
To determine if a Xylocaine jelly (2% infused lidocaine) decreases pain with paracervical block
- DrugSurgilube
To determine if a placebo gel is inferior to lidocaine gel for pain with paracervical block
Location
- University of California, San DiegoLa Jolla, California