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| Name | Class |
|---|---|
| American Academy of Family Physicians National Research Network | NETWORK |
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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lidocaine topical | Drug | 4% aqueous solution |
|
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Patient-reported satisfaction with procedure | 0 - 100% | Obtained immediately after the procedure prior to the patient leaving the clinic |
| Patient-reported interest in subsequent procedure | Likert scale |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Michael J Arnold, MD | Contact | 301-295-9853 | michael.arnold@usuhs.edu | |
| Sajeewanee E Seales, MD | Contact | 301-295-9853 | sajeewane.seales@usuhs.edu |
| Name | Affiliation | Role |
|---|---|---|
| Michael J Arnold, MD | Associate Professor, Uniformed Services University of the Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Family Health Center, USUHS | Bethesda | Maryland | 20814 | United States |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Dec 13, 2022 | May 25, 2023 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D008012 | Lidocaine |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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Study medication provided per randomization table. Study participants allocated sequentially. Subject and provider blinded to allocation
| Tampon | Device | Tampon with plastic applicator provided |
|
| Obtained immediately after the procedure prior to the patient leaving the clinic |
| Provider-reported procedural difficulty | Likert scale | Obtained immediately after the procedure prior to the patient leaving the clinic |
| Aniline Compounds |
| D000588 | Amines |