RECRUITING

Empathy Through Pain Control: Lidocaine Paracervical Block for IUD Placements

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-06-04
Study Completion:2028-06-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06960317

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 50 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Ability to provide informed consent
  2. 2. Women IUD placement for contraception or heavy menstrual bleeding
  3. 3. Ages 18-50
  4. 4. English-speaking
  5. 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
  1. 1. No history of vaginal delivery
  2. 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. 3. Diagnosed chronic pain condition
  4. 4. Current pregnancy
  5. 5. Known allergic reactions to components of the local anesthetic
  6. 6. History of an IUD placement
  7. 7. Current substance use or history of substance use
  8. 8. Known contraindications to IUD, such as unexplained vaginal bleeding

Contacts and Locations

Study Contact

Marisa Hildebrand, MPH
CONTACT
(858) 657-8745
mchildeb@health.ucsd.edu

Principal Investigator

Sheila K Mody, MD, MPH
PRINCIPAL_INVESTIGATOR
UC San Diego

Study Locations (Sites)

University of California, San Diego
La Jolla, California, 92093
United States

Collaborators and Investigators

Sponsor: University of California, San Diego

  • Sheila K Mody, MD, MPH, PRINCIPAL_INVESTIGATOR, UC San Diego

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-06-04
Study Completion Date2028-06-30

Study Record Updates

Study Start Date2025-06-04
Study Completion Date2028-06-30

Terms related to this study

Additional Relevant MeSH Terms

  • Contraception
  • Pain, Acute
  • Anesthesia, Local