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Search / Trial NCT05688943

Comparative Analysis of Spinal Anesthesia Versus General Anesthesia for vNOTES

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

Trial Information

Current as of June 26, 2025

Enrolling by invitation

Keywords

V Notes Tubal Sterilization Regional Anesthesia Laparoscopy

ClinConnect Summary

Anesthesia is a controlled, temporary loss of sensation or awareness used to perform surgical procedures. Spinal anesthesia is commonly used in obstetrics and gynecology for vaginal procedures as well as cesarean sections. The use of spinal anesthesia for laparoscopic surgery is an adequate and safe alternative to general anesthesia which remains the gold standard. Vaginal Natural Orifice Endoscopic Surgery (vNOTES) is a minimally invasive laparoscopic approach used for tubal sterilization that is currently performed under general anesthesia. This study is proposing that spinal anesthesia i...

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.

About University Of Kansas Medical Center

The University of Kansas Medical Center (KUMC) is a leading academic medical institution dedicated to advancing healthcare through innovative research, education, and clinical practice. As a prominent clinical trial sponsor, KUMC leverages its extensive expertise in diverse medical fields to conduct rigorous clinical research aimed at improving patient outcomes and developing new treatment modalities. With a commitment to ethical standards and patient safety, KUMC collaborates with multidisciplinary teams to facilitate groundbreaking studies that address significant health challenges, ultimately contributing to the advancement of medical knowledge and the enhancement of community health.

Locations

Kansas City, Kansas, United States

Kansas City, Kansas, United States

Patients applied

0 patients applied

Trial Officials

Meredith K Gray, MD

Principal Investigator

University of Kansas Medical Center

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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