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

NCT06974019 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 68

Last updated 2025-05-15

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 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.

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 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

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
2025-06-01
Primary Completion
2027-06-30
Completion
2028-06-30

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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 NCT06974019 on ClinicalTrials.gov