Patient-Applied Pretreatment Analgesia for Intrauterine Device Placement

NCT ID: NCT05890495

Last Updated: 2023-06-06

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-30
• Study Completion Date: 2024-01-31

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.

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.

Conditions

Contraception

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Lidocaine topical

Intervention Type: DRUG

4% aqueous solution

Tampon

Intervention Type: DEVICE

Tampon with plastic applicator provided

Saline

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

Group Type: PLACEBO_COMPARATOR

Tampon

Intervention Type: DEVICE

Tampon with plastic applicator provided

Interventions

Lidocaine topical

4% aqueous solution

Intervention Type: DRUG

Tampon

Tampon with plastic applicator provided

Intervention Type: DEVICE

Other Intervention Names

Lidocaine hydrochloride topical solution, USP, 4%

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 54 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

American Academy of Family Physicians National Research Network

NETWORK

Sponsor Role: collaborator

Uniformed Services University of the Health Sciences

FED

Sponsor Role: lead

Responsible Party

Mike Arnold

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Michael J Arnold, MD

Role: PRINCIPAL_INVESTIGATOR

Associate Professor, Uniformed Services University of the Health Sciences

Locations

University Family Health Center, USUHS

Bethesda, Maryland, United States

Countries

United States

Central Contacts

Michael J Arnold, MD

Role: CONTACT

michael.arnold@usuhs.edu

301-295-9853

Sajeewanee E Seales, MD

Role: CONTACT

sajeewane.seales@usuhs.edu

301-295-9853

Facility Contacts

Michael J Arnold, MD

Role: primary

michael.arnold@usuhs.edu

301-295-9853

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

USUHS.2022-103

Identifier Type: -

Identifier Source: org_study_id