Clinical trial NCT05688943: Comparative Analysis of Spinal Anesthesia Versus General Anesthesia for vNOTES
Official title: Comparative Analysis of Spinal Versus General Anesthesia for Vaginal Natural Orifice Transluminal Endoscopic Tubal Sterilization: A Prospective, Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Anesthesia
Tubal Ligation
Keywords: vNOTES
Tubal Sterilization
Regional Anesthesia
laparoscopy
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
First posted: 2023-01-18
Enrollment: 20
Sex: FEMALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This a a randomized control trail that will have 2 groups. One will be the control group and will receive the standard of care, general anesthesia. The other group will be the experimental group which will receive spinal anesthesia in place in general anesthesia.
Primary purpose: OTHER

Brief 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.

Detailed description: 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 is an adequate and safe alternative to general anesthesia for vNOTES tubal sterilization. If participants join the study, all other routine care will continue but the researchers will randomly assign participants, like flipping a coin, to one of two groups. Both types of anesthesia are commonly used but the researchers are doing this study because it is not known if spinal anesthesia is a better alternative than general anesthesia which is typically used. The goal is to find out what might be best for future patients. If it turns out the two types of anesthesia are about the same, then surgeons would know that choosing the type with fewer side effects still gives satisfactory results and allows for this surgery to be performed safely. The risks involved in participating in this study are the same as all other anesthetic and surgical procedures which have significant physical risks. If participants choose to enroll, there will be a 50/50 chance of being assigned to either the standard of care group which will receive general anesthesia or the experimental group which will receive spinal anesthesia. Benefits cannot be guaranteed but, It is possible participants could be assigned to a type of anesthesia that has fewer side effects.

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.

Primary outcomes:
measure: Incidence of perioperative complications performing VNOTES tubal sterilization with Spinal Anesthesia
timeFrame: during surgery
measure: Incidence of perioperative complications performing VNOTES tubal sterilization with Spinal Anesthesia
timeFrame: up to 7 days after surgery
Secondary outcomes:
measure: Rate of post-operative pain between patients
timeFrame: immediately after the surgery
measure: Occurrence of postoperative nausea/vomiting
timeFrame: immediately after the surgery
measure: Compare time until PACU discharge-to-home readiness between patients
timeFrame: immediately after the surgery
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
Study officials:
affiliation: University of Kansas Medical Center
name: Meredith K Gray, MD
role: PRINCIPAL_INVESTIGATOR
References: