NCT06974019

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 68 (estimated)
• Sponsor: University of California, San Diego · Academic / Other
• Sex: Female
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Contraception
• Pain, Acute
• Anesthesia, Local

Interventions

Type	Name	Description
DRUG	Buffered Lidocaine	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
DRUG	Lidocaine 1% Injectable Solution	To determine if the unbuffered 1% lidocaine paracervical block offers any less pain control with IUD placement for nulliparous women

Timeline

• Start date: 2025-06-01
• Primary completion: 2027-06-30
• Completion: 2028-06-30
• First posted: 2025-05-15
• Last updated: 2025-05-15