72
Participants
Start Date
February 28, 2014
Primary Completion Date
March 31, 2015
Study Completion Date
March 31, 2015
In-office Transcervical Sterilization (Essure®)
The standard transcervical sterilization procedure is not being evaluated in this study, and will be performed in the same manner in the two study arms. The procedure includes a standardized paracervical block with 1% lidocaine. A 5mm operative hysteroscope is passed through the cervix and into the uterine cavity using normal saline for uterine distention. Each tubal ostium is identified, followed by deployment of the device into each fallopian tube. A confirmatory test, hysterosalpingogram, is required at 90 days post procedure to demonstrate successful sterilization.
Standard Oral pain medications
one 5/325mg hydrocodone/acetaminophen (Vicodin) tablet and one 1mg Lorazepam tablet given to patients randomized to the active comparator arm at least 30 minutes before the procedure
Intramuscular Ketorolac
30mg of intramuscular ketorolac given to all patients at least 30 minutes before the procedure
Placebo pills
Two placebo bills given to patients randomized to the experimental arm at least 30 minutes prior to the procedure
Oxygen
Oxygen at 5L/min given to patients randomized to the active comparator arm
Nitrous Oxide
Nitrous oxide with a maximum titration of up to 70% given to patients randomized to the experimental arm
UNM Center for Reproductive Health, Albuquerque
Collaborators (1)
Society of Family Planning
OTHER
Bayer
INDUSTRY
University of New Mexico
OTHER