Patient-Applied Pretreatment Analgesia for Intrauterine Device Placement

Contraception Clinical Trial

— PAP-AID  

Official title:

Patient-Applied Pretreatment Analgesia for Intrauterine Device Placement

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05890495
• Other study ID #: USUHS.2022-103
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: June 2023
• Est. completion date: January 2024

Study information

• Verified date: May 2023
• Source: Uniformed Services University of the Health Sciences
• Contact: Michael J Arnold, MD
• Phone: 301-295-9853
• Email: michael.arnold[@]usuhs.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: January 2024
• Est. primary completion date: December 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 54 Years

Eligibility

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

Related Conditions & MeSH terms

• Contraception

Intervention

Drug:
• Lidocaine topical
4% aqueous solution

Device:
• Tampon
Tampon with plastic applicator provided

Locations

Country	Name	City	State
United States	University Family Health Center, USUHS	Bethesda	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Uniformed Services University of the Health Sciences	American Academy of Family Physicians National Research Network

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Procedure time	Time from uterine sounding to cutting strings (to allow for procedures where an IUD is removed prior to placing a new IUD)	Measured during procedure
Primary	Patient-reported pain level	0-10 Visual analog scale	Obtained immediately after the procedure prior to the patient leaving the clinic
Secondary	Patient-reported satisfaction with procedure	0 - 100%	Obtained immediately after the procedure prior to the patient leaving the clinic
Secondary	Patient-reported interest in subsequent procedure	Likert scale	Obtained immediately after the procedure prior to the patient leaving the clinic
Secondary	Provider-reported procedural difficulty	Likert scale	Obtained immediately after the procedure prior to the patient leaving the clinic