NCT06974032

Empathy Through Pain Control: Lidocaine Gel vs. Placebo Prior to IUD Placement

Expanding the Use of Paracervical Block for IUD Placements and Adding a Compassionate Care Assessment- Aim 3

• 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 lidocaine-infused gel and non-medicated gel inserted into the vagina before paracervical block and IUD placement for nulliparous women.

Detailed description

Lidocaine Jelly is a substance that has been approved by the Food and Drug Administration (FDA). At UCSD and other places, it is not currently standard practice for people with prior deliveries birth to receive any sort of vaginal jelly before paracervical block prior to IUD placement. Participants who take part in this study, may receive 6cc of 2% lidocaine gel or 6cc of a non-medicated gel in the vagina before a paracervical block for IUD placement. 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.

Conditions

• Contraception
• Pain, Acute
• Anesthesia, Local

Interventions

Type	Name	Description
DRUG	Xylocaine jelly 2%	To determine if a 6cc of 2% lidocaine jelly decreases pain of paracervical block injection before IUD placement in nulliparous women
DRUG	Surgilube	To determine if the placebo gel increases pain of paracervical block injection before IUD placement in 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