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 patients' opinions of their clinicians' empathy.

The investigators are inviting patients who have never given birth who arrive at their clinic visit seeking an IUD.

Usually, at University of California, San Diego (UCSD), for patients who have never delivered, clinicians numb both the sides of the cervix with a lidocaine-based paracervical block. The purpose of this research study is to compare perceptions of pain between lidocaine-infused gel and non-medicated gel inserted into the vagina before paracervical block and IUD placement for nulliparous women.

Official Title

Expanding the Use of Paracervical Block for IUD Placements and Adding a Compassionate Care Assessment- Aim 3

Details

Lidocaine Jelly is a substance that has been approved by the Food and Drug Administration (FDA). At UCSD and other places, it is not currently standard practice for people with prior deliveries birth to receive any sort of vaginal jelly before paracervical block prior to IUD placement.

Participants who take part in this study, may receive 6cc of 2% lidocaine gel or 6cc of a non-medicated gel in the vagina before a paracervical block for IUD placement.

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, Xylocaine jelly 2%, Surgilube

Eligibility

You can join if…

Open to females ages 18-50

  1. Ability to provide informed consent
  2. Women presenting for 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. Nulliparous (never given birth)

You CAN'T join if...

  1. History of ever giving birth
  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
NCT06974032
Study Type
Interventional
Participants
Expecting 68 study participants
Last Updated