Empathy Through Pain Control: Lidocaine Paracervical Block for IUD Placements
Trial statusRecruiting
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 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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Ability to provide informed consent
Women IUD placement for contraception or heavy menstrual bleeding
Ages 18-50
English-speaking
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Buffered Lidocaine
DrugTo 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 interventionNone - capped needle will not be injected nor will it contain any medication.
Unbuffered lidocaine
DrugTo determine if a 20 cc unbuffered (1% lidocaine) lidocaine paracervical block decreases pain with IUD placement
Xylocaine jelly 2%
DrugTo determine if a Xylocaine jelly (2% infused lidocaine) decreases pain with paracervical block
Surgilube
DrugTo determine if a placebo gel is inferior to lidocaine gel for pain with paracervical block
Treatment groups
204 Participants
are divided into 6 treatment groups6
Treatment groupsSee each treatment group below.
Group A: 1a: Buffered lidocaine paracervical blockExperimental treatment 1 intervention
Group B: 1b: Capped needleSham comparator 1 intervention
Group C: 2a: Buffered lidocaine paracervical blockExperimental treatment 1 intervention
Group D: 2b: Unbuffered lidocaine paracervical blockActive comparator 1 intervention
Group E: 3a: Medicated gelExperimental treatment 1 intervention
Group F: 3b: Non-medicated gelPlacebo 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. 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-procedureSecondary 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-procedureSponsors and contacts
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Source ClinicalTrials.gov