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Not Yet Recruiting NCT05688943

Comparative Analysis of Spinal Anesthesia Versus General Anesthesia for vNOTES

Conditions: Anesthesia, Tubal Ligation

Sex: Female
Ages: 21 Years – N/A
Healthy volunteers: 1
Phase: NA
Enrollment: 40
Sponsor: University of Kansas Medical Center

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.

Eligibility Criteria

Inclusion Criteria:Age ≥21years old keeping in line with regulations posed by federally funded insurance programscis-female or gender non-conforming person with female reproductive organsrequest for permanent sterilizationno prior hysterectomy or trachelectomyundergoing tubal sterilization only or salpingo-oophorectomy only for cancer risk reduction due to genetic pre-dispositionnon-emergent/scheduled outpatient procedurenon-pregnant, ≥6 weeks postpartumAmerican Society of Anesthesia (ASA) physical status classification I or IIAll subjects must be determined to be appropriate candidates for VNOTES by the surgeon based on the review of medical and surgical historyThose 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.

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05688943). StuddyBuddy aggregates publicly available trial information.