Clinical trial

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

Name

STUDY00149365

Description

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.

Trial arms

Trial start

2023-03-01

Estimated PCD

2024-04-15

Trial end

2024-04-15

Status

Recruiting

Treatment

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.

Arms:

Spinal Anesthesia

Other names:

Regional Anesthesia

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.

Arms:

General Anesthesia

Other names:

Endotracheal intubation

Size

Primary endpoint

Incidence of perioperative complications performing VNOTES tubal sterilization with Spinal Anesthesia

during surgery

Incidence of perioperative complications performing VNOTES tubal sterilization with Spinal Anesthesia

up to 7 days after surgery

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.

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '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.', 'primaryPurpose': 'OTHER', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 40, 'type': 'ESTIMATED'}}

Updated at

2023-05-23

1 organization

2 products

2 indications

Organization

University of Kansas Medical Center

Product

Indication

Indication

Product