Topical Anesthetic for IUD Therapy

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: Oregon Health and Science University

Must not be taking: Anxiolytics, Sedatives, Narcotics, others

Disqualifiers: Pregnancy, Chronic pelvic pain, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: Immediate

24 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a topical anesthetic cream (EMLA cream) to make IUD (intrauterine device) placement more comfortable for women. Participants will use one of two methods: applying the cream with a menstrual disc or a cervical cap before IUD insertion. The trial aims to determine which method better reduces pain during the procedure. It seeks women who have never given birth or had a pregnancy beyond 16 weeks, are generally healthy, and plan to have an IUD placed without sedation. As an unphased trial, this study offers a unique opportunity to contribute to research that could enhance comfort during IUD placement.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are taking daily medication for chronic pelvic pain or have used oral anxiolysis, moderate/deep sedation, or narcotics in the past 24 hours, you may not be eligible to participate.

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

Research has shown that EMLA cream, a mix of prilocaine and lidocaine, is generally safe and effective for reducing pain during IUD insertion. Studies indicate that applying EMLA cream to the cervix (the lower part of the uterus) can decrease pain and make the procedure more comfortable. This cream has been used safely in many situations, with few reports of serious side effects.

In this trial, participants will apply EMLA cream using either a cervical cap or a menstrual disc before the IUD is placed. Previous research suggests that these methods are safe and effective for managing pain. The cream has been successfully used in other studies involving IUD insertions, supporting its safety. Participants in those studies did not report significant side effects, indicating that EMLA cream is a safe option for pain relief during IUD placements. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments because they offer a novel way to manage pain during IUD insertion using topical anesthetics. Unlike current pain management options, which might include oral pain relievers or numbing injections, these treatments use EMLA cream, a combination of prilocaine and lidocaine, delivered via a cervical cap or menstrual disc for targeted numbing. This method is non-invasive and allows the anesthetic to be applied directly to the cervix, potentially enhancing comfort and reducing anxiety associated with the procedure. The use of familiar, easy-to-use devices like a cervical cap or menstrual disc could make the process more accessible and less intimidating for patients.

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

This trial will compare two methods of applying lidocaine-prilocaine cream to reduce pain during IUD insertion. Research has shown that lidocaine-prilocaine cream can reduce pain during IUD insertion, with studies indicating a decrease in pain by up to 28% during the procedure. Participants in this trial will receive either a cervical cap or a menstrual disc filled with the cream. Applying the cream to the skin numbs the area. Many patients report feeling no pain or less pain when the cream is used before the procedure. The cream is generally considered safe and effective for this purpose. ^{2 5 6 7 8}

Who Is on the Research Team?

Julia Tasset

Principal Investigator

Oregon Health and Science University

Are You a Good Fit for This Trial?

This trial is for generally healthy, English-speaking women who are scheduled to have an IUD placed at the Center for Women's Health in Complex Family Planning clinic without sedation. Participants must be able to review and sign study consents.

Inclusion Criteria

I am scheduled for an IUD placement at the specified clinic.

I can read and sign the study consent in English.

I am generally in good health.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

Treatment

Participants self-administer a topical anesthetic using a cervical cap or menstrual disc prior to IUD insertion

Immediate

1 visit (in-person)

Follow-up

Participants are monitored for pain, side effects, and procedure complications immediately after IUD placement

1 day

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• EMLA cream

Trial Overview The study is testing two methods of applying a topical anesthetic before IUD insertion: using a menstrual disc or a cervical cap, each filled with EMLA cream. It's designed as an open label, double arm feasibility study with 24 nulliparous women divided into two groups.

How Is the Trial Designed?

Group I: Menstrual disc Experimental Treatment 1 Intervention

Participants will be provided with a menstrual disc filled with 5mg of 2.5% prilocaine-2.5% lidocaine cream and manufacturer instructions for placement. Study personnel will leave the room, and participants will undress and attempt to place the disc. The provider will return to the room, make sure the disc is correctly placed, and set a seven minute timer. After the seven minute timer, participants will self-remove the disc or the clinician will remove it and place the intrauterine device (IUD) according to manufacturer technique.

Group II: Cervical cap Experimental Treatment 1 Intervention

Participants will be provided with a cervical cap filled with 5mg of 2.5% prilocaine-2.5% lidocaine cream and manufacturer instructions for placement. Study personnel will leave the room, and participants will undress and attempt to place the cap. The provider will return to the room, make sure the cap is correctly placed, and set a seven minute timer. After the seven minute timer, participants will self-remove the cap or the clinician will remove it and place the intrauterine device (IUD) according to manufacturer technique.

Who Is Running the Clinical Trial?

Oregon Health and Science University

Lead Sponsor

Trials

1,024

Recruited

7,420,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4802174/

Lidocaine-Prilocaine Cream as Analgesia for IUD Insertion Conclusions: Topical Application of EMLA 5% cream as a topical anesthetic on the cervix before insertion IUD reduced the pain during this procedure.

2. cochranelibrary.com cochranelibrary.com/cdsr/doi/10.1002/14651858.CD007373.pub3/full

Interventions for pain with intrauterine device insertion Pain score for IUC insertion was lower with a lidocaine and prilocaine cream and with 10% lidocaine spray. With 4% lidocaine gel, pain scores ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT02658773?term=Lidocaine%20AND%20Prilocaine&viewType=Table&rank=2

Lidocaine-prilocaine Cream on IUD Insertion Pain Many trials have been done about effectiveness of lidocaine gel in reducing pain during IUD insertion and only one of those trials showed ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7430802/

Effective analgesic options for intrauterine device ... Lidocaine-prilocaine cream (LPC; 2.5% lidocaine and 2.5% prilocaine) reduces the pain of tenaculum placement by 24% and IUD insertion by 28%.

5. researchgate.net researchgate.net/publication/230791266_Effect_of_lidocaine_gel_on_pain_from_copper_IUD_insertion_A_randomized_double-blind_controlled_trial

Effect of lidocaine gel on pain from copper IUD insertion Conclusions: Use of 2% lidocaine gel into the cervical canal has no effect on reducing overall pain during IUD insertion.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06891794

Use of Cervical Cap and Menstrual Disc for Application of ... Cervical cap. Participants will be provided with a cervical cap filled with 5mg of 2.5% prilocaine-2.5% lidocaine cream and manufacturer instructions for ...

7. 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 ... However, data support that cervical application of 5% lidocaine–prilocaine cream reduces pain associated with cervical instrumentation of ...

8. obg.cuhk.edu.hk obg.cuhk.edu.hk/wp-content/uploads/Self-admistered-vaginal-lidocaine-gel-for-pain-management-with-IUD-insertion.pdf

Self-administered vaginal lidocaine gel for pain ... The study coordinators recorded all the procedural data, including IUD type, uterine position, additional cervical manipulation (ie, with uterine sound or os ...