Comparative Analysis of Spinal Anesthesia Versus General Anesthesia for vNOTES

Launched by UNIVERSITY OF KANSAS MEDICAL CENTER · Jan 8, 2023

Keywords

ClinConnect Summary

This study is testing whether spinal anesthesia (numbing the lower spine) can be used safely and effectively for vNOTES tubal sterilization, a minimally invasive vaginal surgery to permanently block the fallopian tubes, compared with the usual general anesthesia (sleep and breathing tube). The researchers will randomly assign about 20 healthy adult participants to either spinal anesthesia or general anesthesia and will compare perioperative complications during surgery and up to 7 days after, as well as immediate postoperative pain, nausea/vomiting, and how long it takes to be ready to go home from the recovery area. Results are not yet available, and recruitment is ongoing at the University of Kansas Medical Center.

Who may be eligible: adults aged 21 or older who are cis-female or gender-non-conforming with female reproductive organs, are seeking permanent sterilization, are scheduled for a non-emergency outpatient vNOTES tubal sterilization, are not pregnant, and are considered healthy enough for surgery (ASA I–II). There are several safety-based exclusions (for example, certain prior surgeries, active pregnancy, or conditions that could complicate anesthesia or vaginal access). If you enroll, you will be randomly assigned to one of the two anesthesia methods, and both options are commonly used in practice. The study aims to help doctors and patients choose the anesthesia approach that offers similar safety with fewer side effects in the future.

Gender

FEMALE

Eligibility criteria

• 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 functioning of neuraxial anesthetics;
• • uncorrected thrombocytopenia or coagulopathy;
• • ASA physical status classification ≥III.