Patient-Applied Pretreatment Analgesia for Intrauterine Device Placement

NCT05890495 | Unknown Phase 4 FDA Drug FDA Device

• 1 other identifier: USUHS.2022-103
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Contraception

Keywords

Long-Acting Reversible Contraception

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Patient-reported satisfaction with procedure

  Obtained immediately after the procedure prior to the patient leaving the clinic

• Patient-reported interest in subsequent procedure

  Obtained immediately after the procedure prior to the patient leaving the clinic

• Provider-reported procedural difficulty

  Obtained immediately after the procedure prior to the patient leaving the clinic

Study Arms (2)

Aqueous lidocaine

EXPERIMENTAL

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; Device: Tampon

Saline

PLACEBO COMPARATOR

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

Device: Tampon

Interventions

Lidocaine topical DRUG

4% aqueous solution

Also known as: Lidocaine hydrochloride topical solution, USP, 4%

Aqueous lidocaine

Tampon DEVICE

Tampon with plastic applicator provided

Aqueous lidocaine; Saline

Eligibility Criteria

• Age: 18 Years - 54 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Uniformed Services University of the Health Sciences: lead
• American Academy of Family Physicians National Research Network: collaborator

Study Sites (1)

University Family Health Center, USUHS

Bethesda, Maryland, 20814, United States

Location

MeSH Terms

Interventions

Lidocaine

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Michael J Arnold, MD

  Associate Professor, Uniformed Services University of the Health Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michael J Arnold, MD

CONTACT

301-295-9853; michael.arnold@usuhs.edu

Sajeewanee E Seales, MD

CONTACT

301-295-9853; sajeewane.seales@usuhs.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: Study medication provided per randomization table. Study participants allocated sequentially. Subject and provider blinded to allocation
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: February 23, 2023
• First Posted: June 6, 2023
• Study Start: June 1, 2023
• Primary Completion: December 1, 2023
• Study Completion: January 1, 2024
• Last Updated: June 6, 2023

Record last verified: 2023-05

Locations

US (1)