Numbing Gel for IUD Insertion

Age: 18+

Sex: Female

Trial Phase: Phase 4

Sponsor: University of Missouri-Columbia

Must not be taking: Anti-inflammatories, Anxiety medications

Disqualifiers: Postpartum, Allergy, Anesthesia, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 3

Duration: 1 day

160 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if applying a numbing gel called benzocaine before a lidocaine injection can reduce pain during IUD (intrauterine device) insertion. Participants will be divided into groups receiving different combinations of benzocaine, lidocaine, and placebo (a substance with no active medication) to identify which combination best reduces discomfort. Individuals aged 18 or older planning to get an IUD may qualify. As a Phase 4 trial, this research involves an FDA-approved treatment and seeks to understand how it can benefit more patients.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot use anti-inflammatory or as-needed anxiety medications in the 12 hours before the IUD insertion.

What is the safety track record for benzocaine and lidocaine?

Research has shown that benzocaine, when used as a gel or spray, is generally well-tolerated during procedures like IUD insertion. Studies have found no major side effects with this use, making it safe for most people.

Lidocaine is also commonly used during IUD insertions to manage pain. Research indicates that injecting lidocaine into the cervix can significantly reduce pain during the procedure.

Both benzocaine and lidocaine are usually safe and have been used in medical settings for a long time. Most people tolerate them well without serious side effects. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about these treatments for IUD insertion because they aim to make the process more comfortable through innovative pain relief methods. Unlike the usual practice of just using lidocaine injections, this trial explores the use of benzocaine spray and a combined approach with both benzocaine and lidocaine. Benzocaine offers a quick and easy topical application, potentially reducing discomfort from needle injections. The combination of benzocaine spray with lidocaine injection targets pain more effectively by addressing both surface and deeper sensations, which could lead to a more comfortable experience for individuals undergoing IUD insertion.

What evidence suggests that this trial's treatments could be effective in decreasing pain during IUD insertion?

This trial will compare different numbing treatments for IUD insertion. Studies have shown that a 2% lidocaine injection in the cervix can significantly reduce pain during IUD insertion. In this trial, some participants will receive lidocaine injections. Research suggests that applying benzocaine on the skin before using lidocaine might enhance pain relief. Benzocaine numbs the skin, which can help lessen needle pain when used with lidocaine. Participants in this trial may receive benzocaine spray, a lidocaine injection, or a combination of both. Using benzocaine and lidocaine together could provide better pain relief than using either one alone. ^{5 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for individuals aged 18 or older who are scheduled to have an IUD inserted and can complete a pain rating scale. There's no specific exclusion criteria provided, but typically participants with allergies to the medications used or certain medical conditions may not be eligible.

Inclusion Criteria

I am getting an IUD inserted.

Exclusion Criteria

IUD insertion <6 weeks postpartum

I am under 18 years old.

I only use anti-inflammatory or anxiety meds occasionally, not daily.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 day

1 visit (in-person)

Treatment

Participants receive either benzocaine/lidocaine, benzocaine/placebo, placebo/lidocaine, or placebo/placebo during IUD insertion

1 day

1 visit (in-person)

Follow-up

Participants are monitored for pain levels during and after the procedure, with an optional survey sent via email

1 day

1 visit (in-person), optional survey (virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Benzocaine
• Lidocaine

Trial Overview The study tests if benzocaine applied before lidocaine injection reduces pain during IUD insertion more than either alone or placebo. Participants will receive ibuprofen, then randomly get one of four treatments: both placebos, placebo/lidocaine, benzocaine/placebo, or benzocaine/lidocaine.

How Is the Trial Designed?

Group I: Placebo/Lidocaine Experimental Treatment 2 Interventions

Participants in this arm will receive saline spray and injected lidocaine to the cervix

Group II: Benzocaine/Placebo Experimental Treatment 2 Interventions

Participants in this arm will receive benzocaine spray and a needle stick without injection to the cervix

Group III: Benzocaine/Lidocaine Experimental Treatment 2 Interventions

Participants in this arm will receive benzocaine spray and lidocaine injection to the cervix

Group IV: Placebo/Placebo Placebo Group 2 Interventions

Participants in this arm will receive saline spray and a needle stick without injection to the cervix

Who Is Running the Clinical Trial?

University of Missouri-Columbia

Lead Sponsor

Trials

387

Recruited

629,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11271754/

Advancing Pain Management Protocols for Intrauterine ... The effectiveness of 10mL of 1% lidocaine gel in relieving pain was inconclusive, with one study finding clinically significant results in ...

2. 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 ... Topical lidocaine spray is more consistently associated with pain reduction over other forms of topical lidocaine. A systematic review and ...

3. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06951191/intrauterine-device-insertion-pain-management?id=849&slug=intrauterine-device

Intrauterine Device Insertion Pain Management The goal of this clinical trial is to learn if use of topical benzocaine prior to the injection of lidocaine is effective in decreasing pain ...

4. withpower.com withpower.com/trial/numbing-gel-for-iud-insertion-755f5

Numbing Gel for IUD Insertion Trial Overview The study tests if benzocaine applied before lidocaine injection reduces pain during IUD insertion more than either alone or placebo.

5. journals.lww.com journals.lww.com/obgynsurvey/fulltext/2025/08000/pain_management_for_iud_insertion__a_review_of_the.20.aspx

Pain Management for IUD Insertion: A Review of the ... IUD insertion pain management interventions with the strongest evidence to date include cervical block, 10% lidocaine spray, and 5% lidocaine-prilocaine cream.

6. acog.org acog.org/news/news-releases/2025/05/acog-releases-new-recommendations-on-pain-management-for-iud-insertions-other-in-office-gynecologic-procedures

ACOG Releases New Recommendations on Pain ... The guidance recommends clinicians offer local anesthetics for IUD insertions, such as lidocaine spray, lidocaine-prilocaine cream, and paracervical block.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11031185/

Provider Perspectives on Analgesic Use in Intrauterine ... This data highlights the lack of a gold standard in analgesic use for IUD insertion procedures and indicates that providers are using their ...

8. trialx.com trialx.com/clinical-trials/listings/307081/intrauterine-device-insertion-pain-management/

Intrauterine Device Insertion Pain Management The goal of this clinical trial is to learn if use of topical benzocaine prior to the injection of lidocaine is effective in decreasing pain ...

9. ajog.org ajog.org/article/S0002-9378(25)00072-9/fulltext

Best practices for reducing pain associated with ... Buffering the lidocaine by combining 2 mL of sodium bicarbonate with 18 mL of 1% lidocaine for a 20 mL block can decrease the burning sensation during injection ...