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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

68 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-01

Study Completion Date

2028-06-30

Brief Summary

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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.

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Detailed Description

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Lidocaine Jelly is a substance that has been approved by the Food and Drug Administration (FDA). At UCSD and other places, it is not currently standard practice for people with prior deliveries birth to receive any sort of vaginal jelly before paracervical block prior to IUD placement.

Participants who take part in this study, may receive 6cc of 2% lidocaine gel or 6cc of a non-medicated gel in the vagina before a paracervical block for IUD placement.

Throughout the local anesthetic and intrauterine device (IUD) placement procedure, research team members will present participants with questionnaires to complete to assess participants' pain, participants' satisfaction with the procedure, and how much empathy participants feel the clinician has shown.

Conditions

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Contraception Pain, Acute Anesthesia, Local

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Two-armed double-blind, randomized controlled

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Participants will not know their group assignment. Clinicians will not know which group the participant is in. The gel will be prepared by another member of the research team.

Study Groups

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2% lidocaine gel (Xylocaine)

Experimental group: will receive 6cc of 2 lidocaine gel (Xylocaine) administered vaginally before paracervical block for IUD placement

Group Type EXPERIMENTAL

Xylocaine jelly 2%

Intervention Type DRUG

To determine if a 6cc of 2% lidocaine jelly decreases pain of paracervical block injection before IUD placement in nulliparous women

Non-Medicated Gel (Surgilube)

Placebo group: will receive 6cc of non-medicated (surgilube) gel administered vaginally before paracervical block for IUD placement

Group Type PLACEBO_COMPARATOR

Surgilube

Intervention Type DRUG

To determine if the placebo gel increases pain of paracervical block injection before IUD placement in nulliparous women

Interventions

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Xylocaine jelly 2%

To determine if a 6cc of 2% lidocaine jelly decreases pain of paracervical block injection before IUD placement in nulliparous women

Intervention Type DRUG

Surgilube

To determine if the placebo gel increases pain of paracervical block injection before IUD placement in nulliparous women

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Ability to provide informed consent
2. Women presenting for IUD placement for contraception or heavy menstrual bleeding
3. Ages 18-50
4. English-speaking
5. Participants must not have a past medical history of substance use disorders, pain disorders, use of prescription pain medications or are found to be pregnant
6. Nulliparous (never given birth)

Exclusion Criteria

1. History of ever giving birth
2. Current use of prescription pain medication prior to procedure. Over-the-counter medications such as those containing ibuprofen, aspirin, acetaminophen, or naproxen are allowed.
3. Diagnosed chronic pain condition
4. Current pregnancy
5. Known allergic reactions to components of the local anesthetic
6. History of an IUD placement
7. Current substance use or history of substance use
8. Known contraindications to IUD, such as unexplained vaginal bleeding

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes