Summary

Eligibility
for females ages 18-50 (full criteria)
Healthy Volunteers
healthy people welcome
Dates
study started
completion around
Principal Investigator
by Sheila K Mody, MD, MPH

Description

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 have a history of giving birth only via C-section who arrive at their clinic visit seeking an IUD.

Usually, at University of California, San Diego (UCSD), for patients who have delivered only via C-section, clinicians numb only the top of the cervix where the clinician places a tenaculum. 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.

Official Title

Expanding the Use of Paracervical Block for IUD Placements and Adding a Compassionate Care Assessment- Aim 1

Details

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) on both sides of the cervix to numb the area.

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.

Keywords

Contraception, Pain, Acute, Anesthesia, Local, Acute Pain, Lidocaine, Buffered Lidocaine, Buffered lidocaine paracervical block, Capped needle

Eligibility

You can join if…

Open to females ages 18-50

  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
  6. History of C-section delivery

You CAN'T join if...

  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

Lead Scientist at UCSD

  • Sheila K Mody, MD, MPH
    Professor Of Clinical, Ob/Gyn & Reproductive sciences, Vc-health Sciences-schools. Authored (or co-authored) 53 research publications

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Diego
ID
NCT06960317
Study Type
Interventional
Participants
Expecting 68 study participants
Last Updated