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Spinal vs General Anesthesia for Tubal Ligation
N/A
Recruiting
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
Study 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.Check my eligibility
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.See study design
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ immediately after the surgery
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~immediately after the surgery
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of perioperative complications performing VNOTES tubal sterilization with Spinal Anesthesia
Secondary outcome measures
Compare time until PACU discharge-to-home readiness between patients
Occurrence of postoperative nausea/vomiting
Rate of post-operative pain between patients
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
463 Previous Clinical Trials
169,230 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am having a procedure for birth control like an IUD or implant.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.My surgeon has approved me for VNOTES surgery after reviewing my medical history.I am having my tubes tied or ovaries removed to lower my cancer risk due to genetics.I am scheduled for a non-urgent outpatient procedure.I am in good or mild systemic disease condition according to ASA.My health is severely impacted by my disease.I am a trans-masculine person considering surgery for masculinization.I am a cis-female or identify differently but have female reproductive organs.I am having surgery for a suspected or confirmed tumor in my reproductive organs.I have had spinal surgery or severe scoliosis that affects anesthesia placement.I have had surgery or was born with a condition that prevents vaginal exams.I am not pregnant and it has been more than 6 weeks since I gave birth.I am 21 years old or older.I have not had a hysterectomy or trachelectomy.
Research Study Groups:
This trial has the following groups:- Group 1: General Anesthesia
- Group 2: Spinal Anesthesia
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many subjects are being admitted to this experiment?
"Yes, the updated information on clinicaltrials.gov shows that this trail is still recruiting patients who fit its criteria. It was initially announced on March 1st 2023 and has been edited recently on May 20th of the same year. This study requires 40 participants from a single medical site."
Answered by AI
Is this medical experiment actively soliciting participants?
"According to clinicaltrials.gov, this medical study is currently accepting participants. The trial was first published on March 1st 2023 and has been updated as recently as May 20th 2023."
Answered by AI
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