NCT06960317

Empathy Through Pain Control: Lidocaine Paracervical Block for IUD Placements

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 204 (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 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.

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 not currently standard practice for people with prior deliveries birth to receive a paracervical block prior to IUD placement. Participants who take part in this study, may receive an injection of buffered lidocaine (2 cc of sodium bicarbonate, 18 cc of 1% lidocaine), an injection of unbuffered block, and/or lidocaine gel. 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	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
OTHER	Sham Comparator	None - capped needle will not be injected nor will it contain any medication.
DRUG	Unbuffered lidocaine	To determine if a 20 cc unbuffered (1% lidocaine) lidocaine paracervical block decreases pain with IUD placement
DRUG	Xylocaine jelly 2%	To determine if a Xylocaine jelly (2% infused lidocaine) decreases pain with paracervical block
DRUG	Surgilube	To determine if a placebo gel is inferior to lidocaine gel for pain with paracervical block

Timeline

• Start date: 2025-06-04
• Primary completion: 2027-06-30
• Completion: 2028-06-30
• First posted: 2025-05-07
• Last updated: 2025-06-13

Locations

1 site across 1 country: United States