Clinical trial NCT05890495: Patient-Applied Pretreatment Analgesia for Intrauterine Device Placement
Official title: Patient-Applied Pretreatment Analgesia for Intrauterine Device Placement
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Contraception
Keywords: Long-Acting Reversible Contraception
Lead sponsor: Uniformed Services University of the Health Sciences
Sponsor class: FED
Collaborators: name: American Academy of Family Physicians National Research Network
First posted: 2023-06-06
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 54
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Procedure time
timeFrame: Measured during procedure
measure: Patient-reported pain level
timeFrame: Obtained immediately after the procedure prior to the patient leaving the clinic
Secondary outcomes:
measure: Patient-reported satisfaction with procedure
timeFrame: Obtained immediately after the procedure prior to the patient leaving the clinic
measure: Patient-reported interest in subsequent procedure
timeFrame: Obtained immediately after the procedure prior to the patient leaving the clinic
measure: Provider-reported procedural difficulty
timeFrame: Obtained immediately after the procedure prior to the patient leaving the clinic
Other outcomes:
Locations:
city: Bethesda
country: United States
facility: University Family Health Center, USUHS
state: Maryland
Study officials:
affiliation: Associate Professor, Uniformed Services University of the Health Sciences
name: Michael J Arnold, MD
role: PRINCIPAL_INVESTIGATOR
References: