Nitrous Oxide for Pain Management During In-office Transcervical Sterilization (NCT02312739) | Clinical Trial Compass
CompletedNot Applicable
Nitrous Oxide for Pain Management During In-office Transcervical Sterilization
United States72 participantsStarted 2014-02
Plain-language summary
This is a randomized, double blind study that aims to measure the difference in maximum pain experienced during in-office transcervical sterilization (Essure®) for women receiving either inhaled nitrous oxide or standard oral analgesia (Vicodin and Lorazepam) with inhaled oxygen.
The investigators hypothesize that inhaled nitrous oxide will reduce the pain experienced more than standard oral medications in women undergoing in-office transcervical sterilization.
Who can participate
Age range
21 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Premenopausal women desiring permanent sterilization and have chosen to proceed with a transcervical sterilization approach
* Speaks English or Spanish
* If relying on state or federal funding for sterilization, must have appropriate federal consents signed 30 days prior to the sterilization procedure
* Agrees to either a hormonal endometrial preparation prior to the procedure or schedule the procedure during the follicular phase (days 5 through 12) of their menstrual cycle
* Sexually active who agrees to contraception for 3 months post procedure, including condoms, followed by a hysterosalpingogram (HSG) for confirmation of fallopian tubal occlusion.
Exclusion Criteria:
* With contraindications for nitrous oxide including: respiratory infection, chronic obstructive pulmonary disease (COPD), intoxication or use of street drugs, inability to breathe through their nose.
* Have taken narcotic pain medications prior to coming to their appointment
* Unsure about desire to end fertility
* History of pelvic inflammatory disease in the past 3 months
* Pregnancy or suspicion of pregnancy
* Delivery or termination of a pregnancy within the last 6 weeks
* Known allergy to contrast
* Uterine anomalies
* Previous tubal surgery
* Cervical or endometrial cancer
* Allergy to Vicodin, lorazepam, or lidocaine.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change From Baseline in Pain Scale Measurement During and After the Procedure
Timeframe: At baseline before the procedure, during the procedure after paracervical block injection and after placement of second Essure® coil, and prior to discharge from clinic (approximately 30-45 minutes postprocedure)