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

Not Applicable

Not yet recruiting

• Conditions: Contraception; Pain, Acute; Anesthesia, Local
• Interventions: Drug: Xylocaine jelly 2%; Drug: Surgilube

• Registration Number: NCT06974032
• Lead Sponsor: University of California, San Diego

Brief 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 lidocaine-infused gel and non-medicated gel inserted into the vagina before paracervical block and IUD placement for nulliparous women.

Detailed Description

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.

Study Timeline

• Status Verified: 2025-05
• Study First Submitted: 2025-05-07
• Study First Submitted QC: 2025-05-07
• Last Update Submitted: 2025-05-07
• Study First Posted: 2025-05-15
• Last Update Posted: 2025-05-15
• Study Start: 2025-06-01
• Primary Completion: 2027-06-30
• Study Completion: 2028-06-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 68

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2% lidocaine gel (Xylocaine)	Xylocaine jelly 2%	Experimental group: will receive 6cc of 2 lidocaine gel (Xylocaine) administered vaginally before paracervical block for IUD placement
Non-Medicated Gel (Surgilube)	Surgilube	Placebo group: will receive 6cc of non-medicated (surgilube) gel administered vaginally before paracervical block for IUD placement

Primary Outcome Measures

Name	Time	Method
Pain scores during IUD placement procedure	From speculum placement to 5 minutes post-procedure	Does 2% lidocaine jelly decrease pain of paracervical block injection before IUD placement procedures among nulliparous women? Pain will be measured on a 10-cm Visual Analog Scale (VAS) with score points ranging from 0-10, where 0 means "No pain" and 10 means "Worst pain possible."
Patient perceptions of clinician empathy	From pre-procedure baseline to 5 minutes post-procedure	What is the relationship between pain and feelings about clinician empathy? Empathy will be measured through answers to the 10-question Consultation and Relational Empathy (CARE) Measure. Each question is answered by a 5-point scale of how well the patient believes their clinician to be at various types of empathetic gestures, where 1 equals "poor" and 5 equals "excellent."