Spinal vs General Anesthesia for Tubal Ligation

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: University of Kansas Medical Center

No Placebo Group

Trial Summary

What is the purpose of this 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.

Eligibility Criteria

This trial is for individuals aged 21 or older who identify as cis-female or gender non-conforming with female reproductive organs, seeking permanent sterilization but not due to urgent conditions. They should be at least 6 weeks postpartum, in good health (ASA I or II), and appropriate for vNOTES surgery. Exclusions include those with certain complex medical histories, recent surgeries, severe spinal issues affecting anesthesia placement, and high-risk ASA classifications.

Inclusion Criteria

I am having a procedure for birth control like an IUD or implant.

My surgeon has approved me for VNOTES surgery after reviewing my medical history.

Request for permanent sterilization

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Exclusion Criteria

I have an urgent gynecological condition like ectopic pregnancy or ovarian torsion.

I have a history of endometriosis or similar conditions that make vaginal surgery riskier.

Uncorrected thrombocytopenia or coagulopathy

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Treatment Details

Interventions

General Anesthesia (Other)
Spinal Anesthesia (Other)
vNOTES (Other)

Trial OverviewThe study is examining the differences between using spinal anesthesia versus general anesthesia during vNOTES tubal sterilization. It aims to see which method leads to fewer complications during surgery, less pain after surgery, reduced nausea and vomiting post-operation, and a quicker recovery time allowing patients to leave the hospital sooner.

Participant Groups

2Treatment groups

Experimental Treatment

Active Control

Group I: Spinal AnesthesiaExperimental Treatment1 Intervention

This arm will receive spinal anesthesia for vNOTES surgery.

Group II: General AnesthesiaActive Control1 Intervention

This arm will receive general anesthesia for vNOTES surgery.