Patient-Applied Pretreatment Analgesia for Intrauterine Device Placement (PAP-AID)

Uniformed Services University (USU)

Status and phase: Not yet enrolling; Phase 4

Conditions: Contraception

Treatments: Drug: Lidocaine topical; Device: Tampon

Study type: Interventional

Funder types: NETWORK; Other U.S. Federal agency

Identifiers

NCT05890495

USUHS.2022-103

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 estimated patients

Sex: Female

Ages: 18 to 54 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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120 participants in 2 patient groups, including a placebo group

Aqueous lidocaine

Experimental group

Description:

Subject issued 5 ml jar of aqueous 4% lidocaine and will dip tampon distal end into jar for 30 seconds prior to placement.

Treatment:

Device: Tampon

Drug: Lidocaine topical

Saline

Placebo Comparator group

Description:

Subject issued 5 ml jar of sterile saline and will dip tampon distal end into jar for 30 seconds prior to placement.

Treatment:

Device: Tampon