Comparative Analysis of Spinal Anesthesia Versus General Anesthesia for vNOTES

Comparative Analysis of Spinal Versus General Anesthesia for Vaginal Natural Orifice Transluminal Endoscopic Tubal Sterilization: A Prospective, Randomized Controlled Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Anesthesia; Tubal Ligation
• Intervention / Treatment: Drug: General Anesthesia; Drug: Spinal Anesthesia

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.

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • Recruiting
      • University of Kansas Medical Center
      • Contact: Shadae K Beale, MD; Phone Number: 913-945-7043; Email: sbeale@kumc.edu
      • Contact: Makenzie Lake; Phone Number: 913-945-7086; Email: mlake2@kumc.edu
      • Principal Investigator: Shadae K Beale, MD
      • Sub-Investigator: Meredith K Gray, MD
      • Sub-Investigator: Melissa Rockford, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: General Anesthesia; This arm will receive general anesthesia for vNOTES surgery.	Drug: General Anesthesia; General anesthesia is a state of controlled unconsciousness. During a general anesthetic, medicines are used to send the participant to sleep making the participant unaware of surgery and so that the participant does not move or feel pain while the surgery is carried out.; Other Names: Endotracheal intubation
Experimental: Spinal Anesthesia; This arm will receive spinal anesthesia for vNOTES surgery.	Drug: Spinal Anesthesia; Fentanyl (1µg/kg) and midazolam are administered intravenously prior to puncture. Using an aseptic technique, the subarachnoid space is punctured with a 25/27 gauge needle in the intervertebral space, and a standard dose of chloroprocaine 45-60mg is injected. The participant is then placed in the supine position in 10-degree Trendelenburg until the lack of sensitivity is adequate at spinal level T4.; Other Names: Regional Anesthesia

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of perioperative complications performing VNOTES tubal sterilization with Spinal Anesthesia	This study seeks to explore the feasibility of performing vaginal natural orifice transluminal endoscopic surgery (VNOTES) tubal sterilization under small-dose spinal anesthesia compared to the gold standard, general anesthesia, in healthy patients and to analyze intraoperative complications.	during surgery
Incidence of perioperative complications performing VNOTES tubal sterilization with Spinal Anesthesia	This study seeks to explore the feasibility of performing vaginal natural orifice transluminal endoscopic surgery (VNOTES) tubal sterilization under small-dose spinal anesthesia compared to the gold standard, general anesthesia, in healthy patients and to analyze postoperative complications.	up to 7 days after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Occurrence of postoperative nausea/vomiting	To determine the differences in the occurrence of postoperative nausea/vomiting (PONV) in a yes or no survey question.	immediately after the surgery
Rate of post-operative pain between patients	To determine the differences in postoperative pain between patients in each anesthesia group based on a pain scale assessed post-operatively.	immediately after the surgery
Compare time until PACU discharge-to-home readiness between patients	To determine the differences in time until post-anesthesia care unit (PACU) discharge-to-home readiness between patients postoperatively.	immediately after the surgery

Collaborators and Investigators

• Sponsor: University of Kansas Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2023
• Primary Completion (Anticipated): April 15, 2024
• Study Completion (Anticipated): April 15, 2024

Study Registration Dates

• First Submitted: December 14, 2022
• First Submitted That Met QC Criteria: January 8, 2023
• First Posted (Actual): January 18, 2023

Study Record Updates

• Last Update Posted (Actual): May 23, 2023
• Last Update Submitted That Met QC Criteria: May 20, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: laparoscopy; Regional Anesthesia; vNOTES; Tubal Sterilization
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics
• Other Study ID Numbers: STUDY00149365

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No