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Spinal vs General Anesthesia for Tubal Ligation

N/A
Waitlist Available
Research Sponsored by University of Kansas Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up immediately after the surgery
Awards & highlights
No Placebo-Only Group

Summary

This trial will compare anesthesia types for a tubal sterilization surgery, to see which has fewer complications, less pain and nausea, and a faster recovery. #medicalresearch

Who is the study for?
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.
What is being tested?
The 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.
What are the potential side effects?
Potential side effects of spinal anesthesia may include lower back pain, headaches, difficulty urinating or low blood pressure. General anesthesia might cause nausea, vomiting, sore throat from the breathing tube used during surgery or confusion upon waking up.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~immediately after the surgery
This trial's timeline: 3 weeks for screening, Varies for treatment, and immediately after the surgery for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Incidence of perioperative complications performing VNOTES tubal sterilization with Spinal Anesthesia
Secondary study objectives
Compare time until PACU discharge-to-home readiness between patients
Occurrence of postoperative nausea/vomiting
Rate of post-operative pain between patients

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Spinal Anesthesia
2014
Completed Phase 4
~2780

Find a Location

Who is running the clinical trial?

University of Kansas Medical CenterLead Sponsor
510 Previous Clinical Trials
176,859 Total Patients Enrolled

Media Library

General Anesthesia (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05688943 — N/A
Tubal Ligation Research Study Groups: General Anesthesia, Spinal Anesthesia
Tubal Ligation Clinical Trial 2023: General Anesthesia Highlights & Side Effects. Trial Name: NCT05688943 — N/A
General Anesthesia (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05688943 — N/A
~19 spots leftby Jul 2026
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