Patient-Applied Pretreatment Analgesia for Intrauterine Device Placement

Phase 4

Not yet recruiting

• Conditions: Contraception
• Interventions: Drug: Lidocaine topical; Device: Tampon

• Registration Number: NCT05890495
• Lead Sponsor: Uniformed Services University of the Health Sciences

Brief Summary

The goal of this clinical trial is to perform a pilot study looking at the benefit of topical anesthetic application to the cervix by tampon prior to intra-uterine device insertion. The main question it aims to answer are:

* Does patient tampon-applied local anesthetic prior to insertion of an intrauterine device (IUD) reduce procedural duration?

* Does patient tampon-applied local anesthetic prior to insertion of an intrauterine device (IUD) reduce pain and improve patient perceptions of the procedure? Participants will place a tampon after dipping the tampon into the study-supplied medication (aqueous lidocaine or saline). Researchers will compare treatment and control groups to see if there is any difference in procedure time, difficulty or patient perceptions.

Detailed Description

This Pilot Randomized Double Blind Clinical Trial study will assess the effectiveness of patient-applied aqueous lidocaine via tampon as a pre-treatment prior to intra-uterine device placement. Subjects will apply the lidocaine or a saline placebo to the end of a standard tampon with a plastic applicator and then place the tampon 1 hour prior to the procedure. The tampon will be removed as the subject prepares for the procedure.

The procedure team will measure the procedure time as well as the subject and provider impressions of the procedure. This data will be evaluated to compare the lidocaine to the control group.

Study Timeline

• Study First Submitted: 2023-02-23
• Status Verified: 2023-05
• Study First Submitted QC: 2023-05-25
• Last Update Submitted: 2023-05-25
• Study Start: 2023-06
• Study First Posted: 2023-06-06
• Last Update Posted: 2023-06-06
• Primary Completion: 2023-12
• Study Completion: 2024-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 120

Inclusion Criteria

• Request IUD insertion
• Age 18 or older
• Willingness to return for procedure after completing virtual study consent

Exclusion Criteria

• Known allergy to viscous lidocaine or tampons
• Current vaginal or cervical injury

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Aqueous lidocaine	Tampon	Subject issued 5 ml jar of aqueous 4% lidocaine and will dip tampon distal end into jar for 30 seconds prior to placement.
Saline	Tampon	Subject issued 5 ml jar of sterile saline and will dip tampon distal end into jar for 30 seconds prior to placement.
Aqueous lidocaine	Lidocaine topical	Subject issued 5 ml jar of aqueous 4% lidocaine and will dip tampon distal end into jar for 30 seconds prior to placement.

Primary Outcome Measures

Name	Time	Method
Procedure time	Measured during procedure	Time from uterine sounding to cutting strings (to allow for procedures where an IUD is removed prior to placing a new IUD)
Patient-reported pain level	Obtained immediately after the procedure prior to the patient leaving the clinic	0-10 Visual analog scale

Secondary Outcome Measures

Name	Time	Method
Patient-reported satisfaction with procedure	Obtained immediately after the procedure prior to the patient leaving the clinic	0 - 100%
Provider-reported procedural difficulty	Obtained immediately after the procedure prior to the patient leaving the clinic	Likert scale
Patient-reported interest in subsequent procedure	Obtained immediately after the procedure prior to the patient leaving the clinic	Likert scale

Trial Locations

Locations (1)

University Family Health Center, USUHS; 🇺🇸 Bethesda, Maryland, United States