Spinal vs General Anesthesia for Tubal Ligation

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: University of Kansas Medical Center

Disqualifiers: Ectopic pregnancy, Endometriosis, Prior genital surgery, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 1 day

20 Participants Needed

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of spinal anesthesia for tubal ligation?

Research shows that spinal anesthesia with xylocaine is safe and effective for postpartum tubal ligation, with a lower incidence of hypotension compared to its use in Cesarean sections. Additionally, spinal ropivacaine is noted for its medium duration and low side effects, making it a suitable option for postpartum tubal ligation. ^{1 2 3 4 5}

Is spinal anesthesia safe for tubal ligation?

Spinal anesthesia is generally safe for tubal ligation, but it can cause low blood pressure in some patients. In a study, 13.5% of patients experienced low blood pressure, and some needed additional pain relief during the procedure. ^{1 2 5 6 7}

How does spinal vs general anesthesia for tubal ligation differ from other treatments?

Spinal anesthesia for tubal ligation is emerging as a favorable alternative to general anesthesia because it offers better control of postoperative pain and may reduce recovery time. Unlike general anesthesia, which affects the whole body, spinal anesthesia numbs only the lower part of the body, potentially leading to fewer complications and a quicker recovery. ^{2 5 6 8 9}

Research Team

Meredith K Gray, MD

Principal Investigator

University of Kansas Medical Center

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

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

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo vNOTES tubal sterilization under either general or spinal anesthesia

1 day

1 visit (in-person)

Immediate Postoperative

Participants are monitored for perioperative complications, postoperative pain, and nausea/vomiting

immediately after surgery

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• General Anesthesia
• Spinal Anesthesia
• vNOTES

Trial Overview 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.

Participant Groups

Group I: Spinal Anesthesia Experimental Treatment 1 Intervention

This arm will receive spinal anesthesia for vNOTES surgery.

Group II: General Anesthesia Active Control 1 Intervention

This arm will receive general anesthesia for vNOTES surgery.

Who Is Running the Clinical Trial?

University of Kansas Medical Center

Lead Sponsor

Trials

527

Recruited

181,000+

References

1. China (Republic : 1949- ) pubmed.ncbi.nlm.nih.gov

Incidence of hypotension induced by spinal anesthesia with xylocaine for cesarean section and postpartum tubal ligation. [2015]

2. United States pubmed.ncbi.nlm.nih.gov

Office Tubal Sterilization [2019]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Minimum effective dose of spinal ropivacaine with and without fentanyl for postpartum tubal ligation. [2018]

4. United States pubmed.ncbi.nlm.nih.gov

A comparison of meperidine and lidocaine for spinal anesthesia for postpartum tubal ligation. [2013]

5. India pubmed.ncbi.nlm.nih.gov

Ambulatory laparoscopic tubal ligation: a comparison of general anaesthesia with local anaesthesia and sedation. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Postoperative vasovagal cardiac arrest after spinal anesthesia for lumbar spine surgery. [2022]

7. Germany pubmed.ncbi.nlm.nih.gov

[The risks of anesthesia in obstetric interventions]. [2007]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Spinal Anesthesia versus General Anesthesia in Gynecological Laparoscopic Surgery: A Systematic Review and Meta-Analysis. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Laparoscopic tubal ligation in a minimally invasive surgical unit under local anesthesia compared to a conventional operating room approach under general anesthesia. [2006]