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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Contraception
• Intervention / Treatment: Drug: Lidocaine topical; Device: Tampon

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 Type: Interventional
• Enrollment (Estimated): 120
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Michael J Arnold, MD; Phone Number: 301-295-9853; Email: michael.arnold@usuhs.edu
• Study Contact Backup: Name: Sajeewanee E Seales, MD; Phone Number: 301-295-9853; Email: sajeewane.seales@usuhs.edu

Study Locations

• United States
  • Maryland
    • Bethesda, Maryland, United States, 20814
      • University Family Health Center, USUHS
      • Contact: Michael J Arnold, MD; Phone Number: 301-295-9853; Email: michael.arnold@usuhs.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Aqueous lidocaine; Subject issued 5 ml jar of aqueous 4% lidocaine and will dip tampon distal end into jar for 30 seconds prior to placement.	Drug: Lidocaine topical; 4% aqueous solution; Other Names: Lidocaine hydrochloride topical solution, USP, 4%; Device: Tampon; Tampon with plastic applicator provided
Placebo Comparator: Saline; Subject issued 5 ml jar of sterile saline and will dip tampon distal end into jar for 30 seconds prior to placement.	Device: Tampon; Tampon with plastic applicator provided

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Patient-reported pain level	0-10 Visual analog scale	Obtained immediately after the procedure prior to the patient leaving the clinic

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Uniformed Services University of the Health Sciences
• Collaborators: American Academy of Family Physicians National Research Network
• Investigators: Principal Investigator: Michael J Arnold, MD, Associate Professor, Uniformed Services University of the Health Sciences

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2023
• Primary Completion (Estimated): December 1, 2023
• Study Completion (Estimated): January 1, 2024

Study Registration Dates

• First Submitted: February 23, 2023
• First Submitted That Met QC Criteria: May 25, 2023
• First Posted (Actual): June 6, 2023

Study Record Updates

• Last Update Posted (Actual): June 6, 2023
• Last Update Submitted That Met QC Criteria: May 25, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Long-Acting Reversible Contraception
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Lidocaine
• Other Study ID Numbers: USUHS.2022-103

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes