Empathy Through Pain Control: Lidocaine Paracervical Block for IUD Placements

Part of paid clinical trials in La Jolla, California.

Sponsor
University of California, San Diego
Study ID
NCT06960317
Status
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
  • Sham Comparator — OTHER
    None - capped needle will not be injected nor will it contain any medication.
  • Unbuffered lidocaine — DRUG
    To determine if a 20 cc unbuffered (1% lidocaine) lidocaine paracervical block decreases pain with IUD placement
  • Xylocaine jelly 2% — DRUG
    To determine if a Xylocaine jelly (2% infused lidocaine) decreases pain with paracervical block
  • Surgilube — DRUG
    To determine if a placebo gel is inferior to lidocaine gel for pain with paracervical block

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 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.

Key Dates

Start date
Jun 4, 2025
Status verified
Jun 2025
Primary completion
Jun 30, 2027
Completion
Jun 30, 2028

Study Design

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

Arms

  • Experimental: 1a: Buffered lidocaine paracervical block
    Treatment group: will receive a 20-mL buffered (2 cc of sodium bicarbonate, 18 cc of 1% lidocaine) paracervical block administered before IUD placement. They will also receive 2 cc of buffered 1% lidocaine at the top of the cervix where the clinician places a tenaculum.
  • Sham Comparator: 1b: Capped needle
    Sham group: will receive a capped needle without any medication administered as paracervical block before IUD placement. They will receive 2 cc of buffered 1% lidocaine at the top of the cervix where the clinician places a tenaculum.
  • Experimental: 2a: Buffered lidocaine paracervical block
    Treatment group: will receive a 20-mL buffered (2 cc of sodium bicarbonate, 18 cc of 1% lidocaine) paracervical block administered before IUD placement. They will also receive 2 cc of buffered 1% lidocaine at the top of the cervix where the clinician places a tenaculum.
  • Active Comparator: 2b: Unbuffered lidocaine paracervical block
    Active comparator group: will receive a 20-mL unbuffered (1% lidocaine) paracervical block administered before IUD placement. They will also receive 2 cc of buffered 1% lidocaine at the top of the cervix where the clinician places a tenaculum.
  • Experimental: 3a: Medicated gel
    Treatment group: will receive lidocaine-infused gel prior to administration of paracervical block.
  • Placebo Comparator: 3b: Non-medicated gel
    Placebo group: will receive a non-medicated gel prior to administration of paracervical block.

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of California, San DiegoLa JollaCalifornia92093
Marisa Hildebrand, MPH
[email protected]
Sheila Mody, MD, MPH (PRINCIPAL_INVESTIGATOR)

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