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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial compares two types of anesthesia—general and spinal—for a surgical procedure called vNOTE tubal sterilization, a method of permanent birth control. Researchers aim to determine which anesthesia type results in fewer complications, such as pain or nausea, and facilitates faster recovery. The trial seeks participants who are cis-female or gender non-conforming with female reproductive organs, seeking permanent sterilization, and not pregnant. Participants should not have undergone surgeries like hysterectomy or have conditions that complicate vaginal access. As an unphased trial, this study offers participants the chance to contribute to valuable research that could enhance surgical outcomes for future patients.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that spinal anesthesia is usually well-tolerated and safe for surgeries like vNOTES. Patients often experience minimal pain after the procedure, and serious complications rarely occur.

General anesthesia also maintains a strong safety record, especially in similar surgeries. It is widely used and considered safe for many types of operations.

Both types of anesthesia have been safely used in numerous patients. However, like any medical procedure, they can cause side effects. These might include nausea or temporary discomfort, but serious issues are uncommon. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about comparing spinal anesthesia and general anesthesia for tubal ligation because each offers unique benefits that could improve patient outcomes. Spinal anesthesia is known for providing effective pain relief with a lower risk of nausea and a quicker recovery time compared to general anesthesia, which typically involves putting the patient to sleep and can have more systemic effects. Additionally, the use of vNOTES (vaginal natural orifice transluminal endoscopic surgery) in this context is less invasive than traditional surgical methods, potentially leading to less pain and faster recovery. This trial could reveal whether one anesthesia method offers superior benefits when combined with this innovative, minimally invasive surgical technique.

What evidence suggests that this trial's anesthesia methods could be effective for tubal ligation?

This trial will compare spinal anesthesia and general anesthesia for vNOTES surgery. Studies have shown that spinal anesthesia can be effective for surgeries like vNOTE tubal sterilization, with success rates between 74% and 92% for similar procedures. However, it may not be reliable for everyone. Participants in this trial may receive spinal anesthesia, which can be effective but varies in reliability. Alternatively, some participants will receive general anesthesia, which is commonly used and usually effective, though it often leads to more nausea and longer recovery times. Both types of anesthesia have their pros and cons, and the choice often depends on individual health and possible side effects. ^{1 6 7 8 9}

Who Is on the Research Team?

Meredith K Gray, MD

Principal Investigator

University of Kansas Medical Center

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0959289X2300328X

A retrospective cohort study of the anesthetic management ... Our analysis revealed an unexpectedly high neuraxial anesthesia failure rate even when de novo spinal anesthesia was used for PPTL. The results are consistent ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6305207/

Neuraxial anesthesia for postpartum tubal ligation at an ... Reported epidural reactivation success rates vary from 74% to 92%. Predictors for reactivation failure include poor patient satisfaction with ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05688943

Comparative Analysis of Spinal Anesthesia Versus ... This study compares general anesthesia and spinal anesthesia for vNOTE tubal sterilization. A direct comparison of these methods has not been done before ...

4. bakirkoymedj.org bakirkoymedj.org/articles/spinal-anesthesia-in-vaginal-natural-orifice-transluminal-endoscopic-surgery-experience-of-12-patients/BMJ.galenos.2021.29981

Spinal Anesthesia in Vaginal Natural Orifice Transluminal ... This study aimed to evaluate the feasibility, effectiveness, and side effects of SA in patients with gynecologic problems who underwent vNOTES.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11282476/

Impact of spinal or epidural anaesthesia on perioperative ... This narrative review summarises recent (2018-2023) evidence about patient-centred outcomes associated with spinal and epidural anaesthesia and analgesia.

6. sciencedirect.com sciencedirect.com/science/article/abs/pii/S2405603022000127

Comparison of two different anesthesia methods on the ... Our results showed that compared with GA, EGA improved the quality of surgical condition in patients undergoing vNOTES.

7. researchgate.net researchgate.net/publication/354904137_Spinal_Anesthesia_in_Vaginal_Natural_Orifice_Transluminal_Endoscopic_Surgery_Experience_of_12_Patients

Spinal Anesthesia in Vaginal Natural Orifice Transluminal ... Laparoscopic surgeries with normal pressure CO2 pneumoperitoneum are feasible and safe under CSE. Incidence of postoperative shoulder pain ...

8. bakirkoymedj.org bakirkoymedj.org/pdf/580eb5e7-1480-44a6-9404-b8b7446acbcb/articles/BMJ.galenos.2021.29981/BTD-17-197-En.pdf

Spinal Anesthesia in Vaginal Natural Orifice Transluminal ... The secondary outcome was the visual analog scale (VAS) scores (VAS; 0, no pain; 10, severe pain), mean heart rate, and mean arterial pressures during the ...

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9792506/

Hysterectomy by transvaginal natural orifice transluminal ... The aim of this study is to evaluate the initial feasibility, safety, and outcomes of hysterectomy performed by transvaginal natural orifice transluminal ...