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

Sponsor
University of California, San Diego
Study ID
NCT06974019
Status
Not Yet Recruiting

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Conditions

  • Anesthesia, Local
  • Contraception
  • Pain, Acute

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 50 Years
Healthy Volunteers
Accepted

Interventions

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

Study Details

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.

Key Dates

First listed
May 15, 2025
Start date
Jun 1, 2025
Status verified
May 2025
Primary completion
Jun 30, 2027
Completion
Jun 30, 2028

Study Design

Enrollment
68 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Buffered lidocaine paracervical block
    Experimental groups: will receive a 20-mL buffered (2 cc of sodium bicarbonate, 18 cc of 1% lidocaine) paracervical block administered before IUD placement.
  • Active Comparator: Unbuffered lidocaine paracervical block
    Active comparator group: will receive a 20-mL unbuffered (20 cc of 1% lidocaine) paracervical block administered before IUD placement.

Primary Outcome Measure

Pain scores during IUD placement procedure [ Time Frame: From speculum placement to 5 minutes post-procedure ]

Central Contacts

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