Contraception, Pain, Acute, Anesthesia, Local
Conditions
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.
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.
Interventions
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.
To determine if a 20 cc unbuffered (1% lidocaine) lidocaine paracervical block decreases pain with IUD placement
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
Sponsors
University of California, San Diego
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
Participants will not know their group assignment. The clinicians will know which group the participant is in.
Intervention model description
6-armed single-blind randomized controlled
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
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. 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain scores during IUD placement procedure | From speculum placement to 5 minutes post-procedure | Does buffered 1% lidocaine paracervical block decrease pain during IUD. placement procedures. Pain will be measured on a 10-cm Visual Analog Scale (VAS) with score points ranging from 0-10, where 0 means No pain and 10 means Worst pain possible. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient perceptions of clinician empathy | From pre-procedure baseline to 5 minutes post-procedure | What is the relationship between pain and feelings about clinician empathy. Empathy will be measured through answers to the 10-question Consultation and Relational Empathy (CARE) Measure. Each question is answered by a 5-point scale of how well the patient believes their clinician to be at various types of empathetic gestures, where 1 equals poor and 5 equals excellent. |
Countries
United States
Contacts
Primary ContactMarisa Hildebrand, MPH
Outcome results
None listed