Lidocaine for Pain Control in Birth Control

(EPIC Trial)

Overseen By Marisa Hildebrand, MPH

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: University of California, San Diego

Must not be taking: Prescription pain medications

Disqualifiers: Chronic pain, Pregnancy, Substance use, others

Compensation: Varies

Number of Visits: 3

Duration: 1 day

204 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

Sheila K Mody, MD, MPH

Principal Investigator

UC San Diego

Are You a Good Fit for This Trial?

This trial is for English-speaking women aged 18-50 seeking an IUD at UCSD for birth control or heavy menstrual bleeding. Candidates must be able to consent, have no history of substance use or pain disorders, not use prescription pain meds, and not be pregnant. Those with a C-section history are included.

Inclusion Criteria

I can understand and agree to the study's details.

I use an IUD for birth control or to manage heavy periods.

I speak English.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (in-person)

Treatment

Participants receive either a buffered or unbuffered lidocaine paracervical block, or a medicated gel prior to IUD placement

1 day

1 visit (in-person)

Follow-up

Participants are monitored for pain levels and perceptions of clinician empathy immediately after the procedure

5 minutes post-procedure

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Lidocaine
• Surgilube
• Xylocaine jelly 2%

Trial Overview The study compares the effectiveness of buffered lidocaine (with sodium bicarbonate), unbuffered lidocaine, medicated gel, and a sham treatment on pain during IUD placement. It also assesses perceived clinician empathy related to these interventions.

How Is the Trial Designed?

Group I: 3a: Medicated gel Experimental Treatment 1 Intervention

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

Group II: 2a: Buffered lidocaine paracervical block Experimental Treatment 1 Intervention

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.

Group III: 1a: Buffered lidocaine paracervical block Experimental Treatment 1 Intervention

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.

Group IV: 2b: Unbuffered lidocaine paracervical block Active Control 1 Intervention

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.

Group V: 1b: Capped needle Placebo Group 1 Intervention

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.

Group VI: 3b: Non-medicated gel Placebo Group 1 Intervention

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

Who Is Running the Clinical Trial?

University of California, San Diego

Lead Sponsor

Trials

1,215

Recruited

1,593,000+