NCT06951191

Intrauterine Device Insertion Pain Management

Applying a New Method for Pain Control in Intrauterine Device Insertion

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 160 (estimated)
• Sponsor: University of Missouri-Columbia · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
DRUG	Benzocaine 20%	Benzocaine 20% topical spray
DRUG	Lidocaine 2%	Lidocaine 2% injectable solution
OTHER	Sham injection	Sham injection to mimic Lidocaine paracervical block. Will use an injection needle and sham inject (no actual injection of fluid)
DRUG	Saline 0.9%	Saline spray to mimic use of benzocaine spray

Timeline

• Start date: 2025-06-23
• Primary completion: 2026-05-01
• Completion: 2026-12-01
• First posted: 2025-04-30
• Last updated: 2025-07-08

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study