Patient-Applied Pretreatment Analgesia for Intrauterine Device Placement
Overview
- Phase
- Phase 4
- Intervention
- Lidocaine topical
- Conditions
- Contraception
- Sponsor
- Uniformed Services University of the Health Sciences
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- Patient-reported pain level
- Status
- Not yet recruiting
- Last Updated
- 2 years ago
Overview
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.
Investigators
Mike Arnold
Associate Professor
Uniformed Services University of the Health Sciences
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
Arms & Interventions
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.
Intervention: Lidocaine topical
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.
Intervention: Tampon
Saline
Subject issued 5 ml jar of sterile saline and will dip tampon distal end into jar for 30 seconds prior to placement.
Intervention: Tampon
Outcomes
Primary Outcomes
Patient-reported pain level
Time Frame: Obtained immediately after the procedure prior to the patient leaving the clinic
0-10 Visual analog scale
Procedure time
Time Frame: 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)
Secondary Outcomes
- Patient-reported satisfaction with 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)
- Patient-reported interest in subsequent procedure(Obtained immediately after the procedure prior to the patient leaving the clinic)