Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:39 AM
Ignite Modification Date:
2025-12-25 @ 2:39 AM
NCT ID:
NCT00613834
Eligibility Criteria:
Inclusion Criteria:
* Female
* Age 18 or older
* Good general health, based on the opinion of the investigator
* Voluntarily requesting permanent sterilization
* Negative pregnancy test
* Agree to premedication with ibuprofen and ativan
* English speaking, or other language if an interpreter is available to be present at all points of the study procedure.
* Willing and able to sign an informed consent
* Willing to comply with the terms of the study
Exclusion Criteria:
* Significant physical or mental health condition, based on the opinion of the investigator.
* Positive pregnancy test
* Request for IV/IM sedation prior to the start of the procedure
* Refusal of ibuprofen, ativan, or paracervical block
* Allergy to any study medication including lidocaine, ibuprofen, ativan, sodium bicarbonate
* History of toxic reaction to local anesthetics
* Known hepatic disease or liver dysfunction. (Lidocaine is metabolized by the liver.)
* Weight less than 100 pounds. \[Any patient weighing less than 100 pounds would receive more than the recommended dose for their weight (4.5 mg/kg or 2 mg/lb)\].
* Current participation in another research study which would interfere with the conduct of this study.
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT00613834
Study Brief:
Protocol Section:
NCT00613834