Empathy Through Pain Control: Lidocaine Paracervical Block for IUD Placements (EPIC)

University of California San Diego

Status: Enrolling

Conditions: Anesthesia, Local; Contraception; Pain, Acute

Treatments: Drug: Xylocaine jelly 2%; Drug: Unbuffered lidocaine; Drug: Surgilube; Drug: Buffered Lidocaine; Other: Sham Comparator

Study type: Interventional

Funder types: Other

Identifiers

NCT06960317

812390

Details and patient eligibility

About

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.

Full description

Lidocaine is a drug that has been approved by the Food and Drug Administration (FDA). Sodium bicarbonate is an additive that buffers the acidity of lidocaine. The combination of the two is safe and effective as a paracervical block for pain relief in various OBGYN procedures. At UCSD and other places, it is not currently standard practice for people with prior deliveries birth to receive a paracervical block prior to IUD placement.

Participants who take part in this study, may receive an injection of buffered lidocaine (2 cc of sodium bicarbonate, 18 cc of 1% lidocaine), an injection of unbuffered block, and/or lidocaine gel.

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.

Enrollment: 204 estimated patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Ability to provide informed consent
2. Women 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

Exclusion criteria

1. No history of vaginal delivery
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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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204 participants in 6 patient groups, including a placebo group

1a: Buffered lidocaine paracervical block

Experimental group

Description:

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.

Treatment:

Drug: Buffered Lidocaine

1b: Capped needle

Sham Comparator group

Description:

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.

Treatment:

Other: Sham Comparator

2a: Buffered lidocaine paracervical block

Experimental group

Description:

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.

Treatment:

Drug: Buffered Lidocaine

2b: Unbuffered lidocaine paracervical block

Active Comparator group

Description:

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.

Treatment:

Drug: Unbuffered lidocaine

3a: Medicated gel

Experimental group

Description:

Treatment group: will receive lidocaine-infused gel prior to administration of paracervical block.

Treatment:

Drug: Xylocaine jelly 2%

3b: Non-medicated gel

Placebo Comparator group

Description:

Placebo group: will receive a non-medicated gel prior to administration of paracervical block.

Treatment:

Drug: Surgilube