Contraception
Conditions
Keywords
Long-Acting Reversible Contraception
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.
Interventions
4% aqueous solution
DEVICETampon
Tampon with plastic applicator provided
Sponsors
American Academy of Family Physicians National Research Network
Uniformed Services University of the Health Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Masking description
Study medication provided per randomization table. Study participants allocated sequentially. Subject and provider blinded to allocation
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 54 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| Patient-reported pain level | Obtained immediately after the procedure prior to the patient leaving the clinic | 0-10 Visual analog scale |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient-reported satisfaction with procedure | Obtained immediately after the procedure prior to the patient leaving the clinic | 0 - 100% |
| Patient-reported interest in subsequent procedure | Obtained immediately after the procedure prior to the patient leaving the clinic | Likert scale |
| Provider-reported procedural difficulty | Obtained immediately after the procedure prior to the patient leaving the clinic | Likert scale |
Countries
United States
Contacts
Primary ContactMichael J Arnold, MD
Backup ContactSajeewanee E Seales, MD
Outcome results
None listed