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NCT Number: NCT06974019

Empathy Through Pain Control: Buffered Compared to Unbuffered 1% Lidocaine During IUD Placement

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 buffered (2 cc of sodium bicarbonate, 18 cc of 1% lidocaine) vs. unbuffered paracervical block (20 cc 1% lidocaine) during IUD placement for nulliparous women.

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Key information

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

About this study

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 currently standard practice for people with no prior deliveries to receive a buffered lidocaine paracervical block prior to IUD placement.

Participants who take part in this study, will be randomly assigned to receive an injection of buffered lidocaine OR an injection of unbuffered lidocaine to numb the area before IUD placement.

Throughout the local anesthetic and intrauterine device (IUD) placement procedure, research team members will question participants about their pain levels, their satisfaction with the procedure, and how much empathy they feel the clinician has shown.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Ability to provide informed consent
  • Women IUD placement for contraception or heavy menstrual bleeding
  • Ages 18-50
  • English-speaking
  • 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
  • Nulliparous (never given birth)

Exclusion criteria

  • History of ever giving birth
  • Current use of prescription pain medication prior to procedure. Over-the-counter medications such as those containing ibuprofen, aspirin, acetaminophen, or naproxen are allowed.
  • Diagnosed chronic pain condition
  • Current pregnancy
  • Known allergic reactions to components of the local anesthetic
  • History of an IUD placement
  • Current substance use or history of substance use
  • Known contraindications to IUD, such as unexplained vaginal bleeding

Treatment and study plan

Buffered Lidocaine

Drug

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 in nulliparous women

Lidocaine 1% Injectable Solution

Drug

To determine if the unbuffered 1% lidocaine paracervical block offers any less pain control with IUD placement for nulliparous women

Primary outcomes

  1. Pain scores during IUD placement procedure

    Time frame: From speculum placement to 5 minutes post-procedure

    Does buffered 1% lidocaine paracervical block decrease pain during IUD placement procedures among nulliparous women? 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 outcomes

  1. Patient perceptions of clinician empathy

    Time frame: 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."

Study contacts

Contact information is provided by the study sponsor or research team.

Marisa Hildebrand, MPH

CONTACT

[email protected]

(858) 657-8745

Sponsors and collaborators

Lead sponsor

University of California, San Diego

Other

Registry information

Acronym: EPIC2

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
May 15, 2025
Registry last updated
May 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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