Comparative Analysis of Spinal Anesthesia Versus General Anesthesia for vNOTES (NCT05688943) | Clinical Trial Compass
By InvitationNot Applicable
Comparative Analysis of Spinal Anesthesia Versus General Anesthesia for vNOTES
United States20 participantsStarted 2023-03-01
Plain-language summary
This study compares general anesthesia and spinal anesthesia for vNOTE tubal sterilization. A direct comparison of these methods has not been done before for this surgical approach. Investigators will aim to compare the two methods to determine the differences in perioperative complications, postoperative pain, postoperative nausea and vomiting, and the time to get the patient ready for discharge from the recovery room.
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:
* Age ≥21years old keeping in line with regulations posed by federally funded insurance programs
* cis-female or gender non-conforming person with female reproductive organs
* request for permanent sterilization
* no prior hysterectomy or trachelectomy
* undergoing tubal sterilization only or salpingo-oophorectomy only for cancer risk reduction due to genetic pre-disposition
* non-emergent/scheduled outpatient procedure
* non-pregnant, ≥6 weeks postpartum
* American Society of Anesthesia (ASA) physical status classification I or II
* All subjects must be determined to be appropriate candidates for VNOTES by the surgeon based on the review of medical and surgical history
* Those undergoing additional procedures such as insertion or removal of a long-acting reversible contraceptive (Intrauterine device or subdermal implant) may be included.
Exclusion Criteria:
* Ectopic pregnancy, ovarian torsion, or adnexal mass requiring urgent or emergent treatment;
* Trans-masculine person considering surgical masculinization due to additional surgeries involved;
* Undergoing adnexal surgery for suspected or confirmed malignancy;
* History of endometriosis, or other inflammatory diseases that have been determined to add to the complexity and increase the risk of injury with vaginal surgery;
* prior genital surgery or congenital abnormality that would prevent vaginal access;
* prior spinal surgery or severe scoliosis that would hinder placement and effective functionin…
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
Incidence of perioperative complications performing VNOTES tubal sterilization with Spinal Anesthesia
Timeframe: during surgery
2
Incidence of perioperative complications performing VNOTES tubal sterilization with Spinal Anesthesia