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NCT Number: NCT06960317

Empathy Through Pain Control: Lidocaine Paracervical Block for IUD Placements

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.

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Key information

Conditions

Contraception Acute Pain Anesthesia, Local Neurologic Manifestations Pain Pain, Acute Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of California, San Diego

La Jolla, California, 92093, United States

Location status: Recruiting

Location contact

Marisa Hildebrand, MPH

CONTACT

[email protected]

Sheila Mody, MD, MPH

PRINCIPAL_INVESTIGATOR

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 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.

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

Exclusion criteria

  • No history of vaginal delivery
  • 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

Sham Comparator

Other

None - capped needle will not be injected nor will it contain any medication.

Unbuffered lidocaine

Drug

To determine if a 20 cc unbuffered (1% lidocaine) lidocaine paracervical block decreases pain with IUD placement

Xylocaine jelly 2%

Drug

To determine if a Xylocaine jelly (2% infused lidocaine) decreases pain with paracervical block

Surgilube

Drug

To determine if a placebo gel is inferior to lidocaine gel for pain with paracervical block

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. 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

Official study title

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

Acronym: EPIC

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
May 7, 2025
Registry last updated
Jun 13, 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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