Empathy Through Pain Control: Lidocaine Paracervical Block for IUD Placements

NCT06960317 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 204

Last updated 2025-06-13

No results posted yet for this study

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.

Conditions

  • Contraception
  • Pain, Acute
  • Anesthesia, Local

Interventions

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

Sponsors & Collaborators

Principal Investigators

  • Sheila K Mody, MD, MPH · UC San Diego

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-06-04
Primary Completion
2027-06-30
Completion
2028-06-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06960317 on ClinicalTrials.gov