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

Trial Summary

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 data supports the effectiveness of the drug for reducing pain during IUD insertion?

Research shows that using lidocaine gel, which is part of the numbing gel treatment, can help reduce pain during IUD insertion. Several studies have found that lidocaine gel is effective in making the procedure more comfortable for women. ^{1 2 3 4 5}

Is the numbing gel safe for use in humans?

Lidocaine, a common numbing agent, has been studied in various forms for reducing pain during IUD insertion and is generally considered safe for human use. Studies have shown no significant adverse effects, and it is well-tolerated when used as a gel or spray for this purpose. ^{1 2 6 7 8}

How does the numbing gel for IUD insertion differ from other treatments?

The numbing gel for IUD insertion is unique because it uses a dual-responsive in situ gel containing lidocaine, which becomes a gel at body temperature and is resistant to dilution by vaginal fluids, providing effective pain relief during IUD insertion. This formulation allows for easy self-administration and significant pain reduction compared to other methods like sprays or infusions. ^{1 3 7 8 9}

What is the purpose of this trial?

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 experienced during IUD insertion in patients 18 or older. The main question it aims to answer is: Does topical use of benzocaine prior to lidocaine injection during IUD insertion effectively decrease pain experienced? Researchers will compare benzocaine/lidocaine to benzocaine/placebo, placebo/lidocaine, and placebo/placebo to see if use of benzocaine prior to lidocaine injection works more effectively to decrease pain experienced rather than lidocaine, benzocaine, or placebo use alone. Participants will: * Arrive to clinic for previously scheduled IUD insertion * Be screened, approached by research staff, and consented to join the trial * Complete a demographic questionnaire * Be randomly and blindly assigned to one of four groups * Placebo/Placebo * Placebo/Lidocaine * Benzocaine/Placebo * Benzocaine/Lidocaine * All groups will be given 600mg of ibuprofen prior to procedure * Be asked to rate their pain on a visual scale of 1-10 during several distinct points of the procedure. * Be sent an optional survey to their email after the procedure

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

References

1. United States pubmed.ncbi.nlm.nih.gov

Higher dose cervical 2% lidocaine gel for IUD insertion: a randomized controlled trial. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Self-administrated vaginal 2% lidocaine in-situ gel for pain relief during copper intrauterine device insertion in women with previous caesarean delivery only: a randomised, double-blind placebo-controlled trial. [2023]

3. India pubmed.ncbi.nlm.nih.gov

Effect of lidocaine gel on pain from copper IUD insertion: a randomized double-blind controlled trial. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Cervical lidocaine for IUD insertional pain: a randomized controlled trial. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Self-Administered Lidocaine Gel for Intrauterine Device Insertion in Nulliparous Women: A Randomized Controlled Trial. [2017]

6. United States pubmed.ncbi.nlm.nih.gov

Novel topical formulation of lidocaine provides significant pain relief for intrauterine device insertion: pharmacokinetic evaluation and randomized placebo-controlled trial. [2015]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Dual-responsive lidocaine in situ gel reduces pain of intrauterine device insertion. [2018]

8. England pubmed.ncbi.nlm.nih.gov

Lidocaine 10% spray to the cervix reduces pain during intrauterine device insertion: a double-blind randomised controlled trial. [2017]

9. United States pubmed.ncbi.nlm.nih.gov

Intrauterine infusion of lidocaine does not reduce pain scores during IUD insertion. [2013]