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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-50
SponsorUniversity of California, San Diego

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Ability to provide informed consent

Women IUD placement for contraception or heavy menstrual bleeding

Ages 18-50

English-speaking

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

Treatment groups

68 Participants
are divided into 2 treatment groups
Group A: Buffered lidocaine paracervical blockExperimental treatment 1 intervention
Group B: Unbuffered lidocaine paracervical blockActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Pain scores during IUD placement 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."

Time frame
From speculum placement to 5 minutes post-procedure

Secondary outcomes

1

Patient perceptions of clinician empathy

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."

Time frame
From pre-procedure baseline to 5 minutes post-procedure

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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