Intrauterine Device Insertion Pain Management

NCT ID: NCT06951191

Last Updated: 2025-07-08

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 160 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-23
• Study Completion Date: 2026-12-31

Brief Summary

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

Detailed Description

The goal of the researchers is to determine if use of a topical benzocaine spray prior to lidocaine injection will cause a significant reduction in pain experienced by patients undergoing an IUD insertion. Participants will be screened, approached, and fully consented by research staff in the clinic prior to their IUD insertion. Demographics will be gathered from all participants through a questionnaire. All participants will be given 600mg of ibuprofen prior to the procedure, but will be randomized into one of 4 groups as to what interventions/placebos they will receive during their insertion. Interventions studied are benzocaine spray and lidocaine injection. Placebos will be saline spray and paracervical needle stick without injection. Participants will be asked to rate their pain on a visual scale of 1-10 at the following timepoints during the procedure:

• At the time of tenaculum placement
• At the time of uterine sounding
• At the time of IUD insertion and deployment
• Immediately after removal of instrumentation
• 15 minutes after the procedure Participants who provided an email will be sent an additional questionnaire to be responded to within 24 hours of the procedure. At the conclusion of the trial statistical analysis will be done to determine significance of pain reduction varying between the 4 groups.

Conditions

IUD Insertion Pain; IUD Insertion

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Placebo/Placebo

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

Group Type: PLACEBO_COMPARATOR

Sham injection

Intervention Type: OTHER

Sham injection to mimic Lidocaine paracervical block. Will use an injection needle and sham inject (no actual injection of fluid)

Saline 0.9%

Intervention Type: DRUG

Saline spray to mimic use of benzocaine spray

Placebo/Lidocaine

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

Group Type: EXPERIMENTAL

Lidocaine 2%

Intervention Type: DRUG

Lidocaine 2% injectable solution

Saline 0.9%

Intervention Type: DRUG

Saline spray to mimic use of benzocaine spray

Benzocaine/Placebo

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

Group Type: EXPERIMENTAL

Benzocaine 20%

Intervention Type: DRUG

Benzocaine 20% topical spray

Sham injection

Intervention Type: OTHER

Sham injection to mimic Lidocaine paracervical block. Will use an injection needle and sham inject (no actual injection of fluid)

Benzocaine/Lidocaine

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

Group Type: EXPERIMENTAL

Benzocaine 20%

Intervention Type: DRUG

Benzocaine 20% topical spray

Lidocaine 2%

Intervention Type: DRUG

Lidocaine 2% injectable solution

Interventions

Benzocaine 20%

Benzocaine 20% topical spray

Intervention Type: DRUG

Lidocaine 2%

Lidocaine 2% injectable solution

Intervention Type: DRUG

Sham injection

Sham injection to mimic Lidocaine paracervical block. Will use an injection needle and sham inject (no actual injection of fluid)

Intervention Type: OTHER

Saline 0.9%

Saline spray to mimic use of benzocaine spray

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 18 years of age or older
• Undergoing IUD insertion

Exclusion Criteria

• IUD insertion <6 weeks postpartum
• Age <18 years
• Allergy or history of adverse effect of lidocaine, benzocaine (and inactive ingredients: flavor, isobutane, propane, polyethylene glycol, sodium saccharin), or ibuprofen
• Not undergoing IUD insertion
• Undergoing IUD insertion under general anesthesia
• Usage of anti-inflammatory or as-needed anxiety medications (not daily use) in the 12 hours prior to IUD insertion

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of Missouri-Columbia

OTHER

Sponsor Role: lead

Responsible Party

Kirby Woodall

Obstetrician/Gynecologist (MD)

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Missouri OB/GYN Associates-Smiley Lane

Columbia, Missouri, United States

Site Status: RECRUITING

Countries

United States

Facility Contacts

Kirby Woodall, MD

Role: primary

woodallk@health.missouri.edu

573-817-3535

Other Identifiers

2101465

Identifier Type: -

Identifier Source: org_study_id