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?

This trial tests how different uses of lidocaine, a numbing medication, can reduce pain during IUD (intrauterine device) placement. Researchers are exploring various methods, such as comparing buffered and unbuffered lidocaine and using a medicated gel, to determine which option best eases discomfort. They are also interested in participants' views on their clinicians' empathy during the procedure. The trial seeks women planning to get an IUD for birth control or heavy menstrual bleeding who have not given birth vaginally. As an unphased trial, it offers participants the opportunity to contribute to research that could improve comfort during IUD placement.

Will I have to stop taking my current medications?

You will need to stop taking any prescription pain medications before the procedure, but you can continue using over-the-counter medications like ibuprofen, aspirin, acetaminophen, or naproxen.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that lidocaine, a numbing medication, is generally safe and effective for easing pain during IUD placements. Studies have found that a buffered lidocaine paracervical block, which combines lidocaine with sodium bicarbonate, can significantly reduce pain. Specifically, one study found that using 20 mL of buffered lidocaine noticeably lowered pain scores during the procedure.

Buffered lidocaine is not new in medical use. It is commonly used in many procedures, and patients usually tolerate it well. Importantly, it has a history of being well-tolerated with minimal side effects.

Unbuffered lidocaine, which lacks sodium bicarbonate, has also been shown to help with pain during IUD insertion. Like the buffered version, it is considered safe and is widely used in medical settings.

For lidocaine-infused gel, research suggests it might be effective in reducing pain, although some studies show mixed results. However, the gel is generally safe and has been used in different settings without major issues.

In summary, lidocaine in its various forms—buffered, unbuffered, and gel—has been used safely in many procedures, including IUD placement. Patients usually tolerate these treatments well, with few reported side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using lidocaine for pain control during IUD placement because it introduces new ways to enhance comfort without significantly altering the procedure. Unlike traditional methods, which might not always provide sufficient pain relief, this approach uses buffered lidocaine, which can potentially offer more effective and quicker pain relief by neutralizing acidity that typically causes discomfort during injection. Another innovative feature is the use of lidocaine-infused gel, which could provide a soothing pre-treatment to further ease the process. These advancements aim to make IUD placement a more comfortable experience, potentially increasing acceptance and adherence to this form of birth control.

What evidence suggests that this trial's treatments could be effective for pain control during IUD placement?

This trial will compare different methods of pain control during IUD placement. Research has shown that a buffered lidocaine paracervical block, which some participants in this trial will receive, can greatly reduce pain during the procedure. One study found that a 20 mL dose of buffered 1% lidocaine made the procedure more comfortable by lowering pain scores. Another study confirmed that this method significantly reduces pain.

Participants in another arm will receive an unbuffered lidocaine paracervical block. Research indicates that unbuffered lidocaine can also lessen pain during IUD placement, though the buffered version appears more effective based on current findings.

Additionally, some participants will receive lidocaine-infused gel. Studies have shown that this gel has not significantly reduced pain during IUD insertion, with some findings indicating it did not lower pain scores much compared to options without medication. ^{1 2 4 6 7}

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6438819/

Paracervical Block for Intrauterine Device Placement ... A trial utilizing a 10 cc 1% lidocaine block demonstrated a decrease in pain with IUD placement among nulliparous adolescents (14–25 years old) ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT02219308

Study Details | NCT02219308 | Pain Control for Intrauterine ... We hypothesize that administration of a PCB of 20 mL 1% buffered lidocaine prior to IUD placement will decrease pain scores by at least 20mm on a visual analog ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S0002937825004971

Variability in pain management utilization during ... 10, 11, 12 Specifically, paracervical block using 20 mL of buffered 1% lidocaine has been shown to decrease perceived pain with uterine sounding ...

4. acog.org acog.org/clinical/clinical-guidance/clinical-consensus/articles/2025/05/pain-management-for-in-office-uterine-and-cervical-procedures

Pain Management for In-Office Uterine and Cervical ... An RTC of 140 patients demonstrated significant pain reduction with the use of a paracervical block with divided dosing injections of 20 mL 1% ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/30095776/

Paracervical Block for Intrauterine Device Placement Among ... Conclusion: A 20-mL buffered 1% lidocaine paracervical block decreases pain with IUD placement (primary outcome), uterine sounding (secondary outcome), and 5 ...

6. ebwhj.journals.ekb.eg ebwhj.journals.ekb.eg/article_343457.html

Efficacy and Safety of Paracervical Block in Reducing ... Women who received the paracervical block reported less pain with IUD insertion compared to women who received no block( median VAS score of 20.9 mm versus 37.4 ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S0002937825000729

Best practices for reducing pain associated with ... Another study of buffered 20 mL 1% lidocaine among nulliparous patients reported a significant decrease in pain scores during placement, uterine sounding, and 5 ...