Empathy Through Pain Control: Lidocaine Gel vs. Placebo Prior to IUD Placement

Sponsor
University of California, San Diego
Study ID
NCT06974032
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

  • Xylocaine jelly 2% — DRUG
    To determine if a 6cc of 2% lidocaine jelly decreases pain of paracervical block injection before IUD placement in nulliparous women
  • Surgilube — DRUG
    To determine if the placebo gel increases pain of paracervical block injection before IUD placement in 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 lidocaine-infused gel and non-medicated gel inserted into the vagina before paracervical block and 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: 2% lidocaine gel (Xylocaine)
    Experimental group: will receive 6cc of 2 lidocaine gel (Xylocaine) administered vaginally before paracervical block for IUD placement
  • Placebo Comparator: Non-Medicated Gel (Surgilube)
    Placebo group: will receive 6cc of non-medicated (surgilube) gel administered vaginally before paracervical block for 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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