Analgesia for Pain During IUD Placement

Overseen By Pamela Berens, MD

Age: 18+

Sex: Female

Trial Phase: Phase 2

Sponsor: The University of Texas Health Science Center, Houston

Disqualifiers: Pelvic inflammatory disease, Malignancy, others

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

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

Compensation: Varies

Number of Visits: 1

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores methods to reduce pain during IUD insertion, a type of birth control. Researchers are testing three methods: benzocaine gel applied to the cervix, a paracervical block with lidocaine (a numbing injection), and no pain relief, to determine the most effective approach. Participants may receive hydroxyzine, an additional medication, if needed, to help with anxiety. The trial is open to individuals scheduled for IUD insertion or an EMB procedure, who do not have pelvic inflammatory disease or certain other health conditions. The study aims to improve comfort and pain management during these procedures. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, allowing participants to contribute to advancements in pain management.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

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

Research has shown that applying benzocaine gel to the cervix significantly reduces pain after gynecological procedures, indicating it is generally well-tolerated. Similarly, studies have indicated that a paracervical block with lidocaine effectively lessens pain during IUD placement and is considered safe and effective, with no major side effects commonly reported.

The trial is in Phase 2, indicating some initial safety information is available, but more data is needed. Overall, both benzocaine and lidocaine are commonly used for pain relief, suggesting they are generally safe in most cases. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments for pain during IUD placement because they offer potentially more comfortable experiences for patients. The use of benzocaine gel applied directly to the cervix is unique because it provides localized pain relief with minimal systemic effects. The paracervical block using lidocaine without epinephrine is another promising option as it numbs the cervix effectively, potentially reducing pain significantly without the adrenaline-related side effects. Additionally, incorporating hydroxyzine hydrochloride if needed offers an extra layer of anxiety relief, making the overall procedure less daunting. These treatments aim to provide quicker and targeted pain management compared to standard options like oral analgesics or NSAIDs, which may not offer immediate or sufficient relief during the procedure.

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

This trial will compare different analgesia methods for pain during IUD placement. Research has shown mixed results for using benzocaine gel on the cervix to relieve pain during IUD insertion. Some studies suggest it might not work as well as other pain relief methods. In contrast, a paracervical block with lidocaine, another treatment arm in this trial, significantly reduces pain during IUD insertion. Studies demonstrate that this method effectively lowers pain compared to not using any pain relief. Both treatments aim to make the procedure more comfortable, but lidocaine has more consistent evidence supporting its effectiveness. ^{1 2 3 6 7}

Who Is on the Research Team?

Pamela Berens, MD

Principal Investigator

The University of Texas Health Science Center, Houston

Are You a Good Fit for This Trial?

This trial is for individuals scheduled for an IUD insertion or endometrial biopsy (EMB) procedure. It's not open to those with pelvic inflammatory disease, contraindications to IUD/EMB, a positive pregnancy test, cancer history, or allergies to hydroxyzine, lidocaine, or benzocaine.

Inclusion Criteria

I am here for an IUD insertion or an endometrial biopsy.

Exclusion Criteria

Contraindications to IUD or EMB

I currently have pelvic inflammatory disease.

Positive pregnancy test

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo IUD insertion or endometrial biopsy with or without analgesia

1 day

1 visit (in-person)

Follow-up

Participants are monitored for pain perception and anxiety levels after the procedure

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Benzocaine Gel applied to the cervix
• Hydroxyzine Hydrochloride
• Paracervical block- Lidocaine without epinephrine

Trial Overview The study tests if using analgesia like lidocaine injections without epinephrine and benzocaine gel on the cervix reduces anxiety and pain during IUD placement/EMB compared to no pain relief. It also looks at how factors like age and race affect pain management.

How Is the Trial Designed?

Group I: Paracervical block- Lidocaine without epinephrine with Hydroxyzine hydrochloride if needed Experimental Treatment 2 Interventions

Group II: No analgesia with Hydroxyzine hydrochloride if needed Experimental Treatment 1 Intervention

Group III: Benzocaine Gel applied to the cervix with Hydroxyzine hydrochloride if needed Experimental Treatment 2 Interventions

Who Is Running the Clinical Trial?

The University of Texas Health Science Center, Houston

Lead Sponsor

Trials

974

Recruited

361,000+

Citations

1. 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 ... Several pain-management interventions being used have limited or conflicting evidence supporting their effectiveness at providing adequate pain control.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11569790/

Pain Management During Intrauterine Device Insertion in ... Cervical blocks using 1% lidocaine were shown to decrease pain during cervical gripping (p=0.002) and IUD insertion compared to the control ...

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

Best practices for reducing pain associated with ... This article aims to provide practical, evidence-based, and expert-informed guidelines for managing pain during intrauterine device placement.

4. ajog.org ajog.org/article/S0002-9378(24)00624-0/fulltext

Mepivacaine instillation for pain reduction during ... The intrauterine instillation of mepivacaine results in statistically significant reduction in pain score among nulliparous women during IUD ...

5. cureus.com cureus.com/articles/229842-differing-approaches-to-pain-management-for-intrauterine-device-insertion-and-maintenance-a-scoping-review.pdf

Differing Approaches to Pain Management for Intrauterine ... Participants receiving diclofenac and lidocaine gel combo had lower pain scores during tenaculum application and IUD insertion. Pain scores ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/2657523/

Topical anesthesia for gynecologic procedures These data indicate that benzocaine 20% significantly reduces the pain experienced by patients after many gynecologic procedures performed vaginally.

7. fertstert.org fertstert.org/article/S0015-0282(18)32207-6/fulltext

a systematic review and network meta-analysis Lidocaine-prilocaine cream is the most effective medication that can be used for IUD insertion-related pain. Other medications are not effective ...