Enrolling by InvitationN/AOther

Comparative Analysis of Spinal Anesthesia Versus General Anesthesia for vNOTES

Sponsored by University of Kansas Medical Center

NCT ID
NCT05688943
Target Enrollment
20 participants
Start Date
2023-03-01
Est. Completion
2026-07-15

About This Study

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.

Conditions Studied

AnesthesiaTubal Ligation

Interventions

  • Spinal Anesthesia
  • General Anesthesia

Eligibility

Sex:FEMALE
Age:21 Years - N/A
Healthy Volunteers:Yes
View full 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.

Study Locations (1)

University of Kansas Medical Center
Kansas City, Kansas, United States

Interested in this trial?

Contact the study team to learn more about eligibility and enrollment.

View on ClinicalTrials.gov
Data Source
ClinicalTrials.gov

Last updated from source