Intrauterine Device Insertion Pain Management

NCT06951191 | Terminated Phase 4 FDA Drug

• 1 other identifier: 2101465
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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

Conditions

IUD Insertion Pain; IUD Insertion

Keywords

IUD; IUD insertion; IUD insertion pain; benzocaine; paracervical lidocaine; paracervical block

Outcome Measures

Primary Outcomes (1)

• Mean Pain Score During IUD Insertion Events as Quantified by Visual Analogue Scale

  The Visual Analogue Scale (VAS) is a 0-10 pain intensity scale commonly used to assess pain intensity. Scores of 0 represent having no pain at all while scores of 10 represent worst pain possible; Therefore higher scores represent worse outcomes for pain management. VAS will be used to determine participant's levels of experienced pain at the 5 distinct events (tenaculum placement, uterine sounding, IUD insertion/deployment, immediately after instrumentation removal, 15 minutes post-procedure).

  During IUD insertion procedure

Study Arms (4)

Placebo/Placebo

PLACEBO COMPARATOR

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

Other: Sham injection; Drug: Saline 0.9%

Placebo/Lidocaine

EXPERIMENTAL

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

Drug: Lidocaine 2%; Drug: Saline 0.9%

Benzocaine/Placebo

EXPERIMENTAL

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

Drug: Benzocaine 20%; Other: Sham injection

Benzocaine/Lidocaine

EXPERIMENTAL

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

Drug: Benzocaine 20%; Drug: Lidocaine 2%

Interventions

Benzocaine 20% DRUG

Benzocaine 20% topical spray

Benzocaine/Lidocaine; Benzocaine/Placebo

Lidocaine 2% DRUG

Lidocaine 2% injectable solution

Benzocaine/Lidocaine; Placebo/Lidocaine

Sham injection OTHER

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

Benzocaine/Placebo; Placebo/Placebo

Saline 0.9% DRUG

Saline spray to mimic use of benzocaine spray

Placebo/Lidocaine; Placebo/Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age or older
• Undergoing IUD insertion

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Missouri-Columbia: lead

Study Sites (1)

Missouri OB/GYN Associates-Smiley Lane

Columbia, Missouri, 65202, United States

Location

MeSH Terms

Interventions

salicylhydroxamic acid; Sodium Chloride

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Obstetrician/Gynecologist (MD)

Study Record Dates

• First Submitted: April 22, 2025
• First Posted: April 30, 2025
• Study Start: June 23, 2025
• Primary Completion: April 15, 2026
• Study Completion: April 15, 2026
• Last Updated: April 21, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: IPD will be made available via link after conclusion of study (anticipated by 12/31/2026) and will remain available indefinitely on the MOspace institutional repository so long as that service remains active.
• Access Criteria: IPD will be made available to all through the use of the MOspace institutional repository. Individual participant data will be available on a spreadsheet detailing study arm, age, parity, and pain-scoring at the different intervals. This will be accessible through a unique URL that will be provided at the conclusion of the study and upon upload to the MOspace repository.

Locations

US (1)