Clincosm LogoSign in Get a demo

PAP-AID: Patient-Applied Pretreatment Analgesia for Intrauterine Device Placement

Sponsor
Uniformed Services University of the Health Sciences (U.S. Fed)
Overall Status
Not yet recruiting
CT.gov ID
NCT05890495
Collaborator
American Academy of Family Physicians National Research Network (Other)
120
Enrollment
1
Location
2
Arms
7
Anticipated Duration (Months)
17.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Lidocaine topical
  • Device: Tampon
 Phase 4

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 Design

Study Type:
Interventional
Anticipated Enrollment :
120 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Care Provider)
Masking Description:
Study medication provided per randomization table. Study participants allocated sequentially. Subject and provider blinded to allocation
Primary Purpose:
Treatment
Official Title:
Patient-Applied Pretreatment Analgesia for Intrauterine Device Placement
Anticipated Study Start Date :
Jun 1, 2023
Anticipated Primary Completion Date :
Dec 1, 2023
Anticipated Study Completion Date :
Jan 1, 2024

Arms and Interventions

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

    Outcome Measures

    Primary Outcome Measures

    1. 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)

    2. Patient-reported pain level [Obtained immediately after the procedure prior to the patient leaving the clinic]

      0-10 Visual analog scale

    Secondary Outcome Measures

    1. Patient-reported satisfaction with procedure [Obtained immediately after the procedure prior to the patient leaving the clinic]

      0 - 100%

    2. Patient-reported interest in subsequent procedure [Obtained immediately after the procedure prior to the patient leaving the clinic]

      Likert scale

    3. Provider-reported procedural difficulty [Obtained immediately after the procedure prior to the patient leaving the clinic]

      Likert scale

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 54 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University Family Health Center, USUHS Bethesda Maryland United States 20814

    Sponsors and Collaborators

    • Uniformed Services University of the Health Sciences
    • 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 Documents (Full-Text)

    More Information

    Publications

    None provided.
    Responsible Party:
    Mike Arnold, Associate Professor, Uniformed Services University of the Health Sciences
    ClinicalTrials.gov Identifier:
    NCT05890495
    Other Study ID Numbers:
    • USUHS.2022-103
    First Posted:
    Jun 6, 2023
    Last Update Posted:
    Jun 6, 2023
    Last Verified:
    May 1, 2023
    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
    Keywords provided by Mike Arnold, Associate Professor, Uniformed Services University of the Health Sciences
    Long-Acting Reversible Contraception
    Additional relevant MeSH terms:
    Lidocaine

    Study Results

    No Results Posted as of Jun 6, 2023