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 in nulliparous women
NCT Number: NCT06974019
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.
Trial opening soon.
Get Notified18 year–50 year
Female
Interventional
Not applicable
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
To determine if the unbuffered 1% lidocaine paracervical block offers any less pain control with IUD placement for nulliparous women
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."
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."
Contact information is provided by the study sponsor or research team.
University of California, San Diego
Other
Acronym: EPIC2
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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