General vs. Spinal Anesthesia for Lumbar Surgery

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Hospital for Special Surgery, New York

Disqualifiers: Morbid obesity, Allergies, others

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

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 2

Duration: Intraoperative

142 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to determine the optimal anesthetic routine for lumbar decompression surgery. General Anesthesia is the standard of care in spine surgery. Spinal anesthesia in decompressive procedures can be the new standard of care. Recently, it has been found that regional analgesia is option that has been shown to improve pain and opioid-related outcomes after spine surgery, but has not yet been studied in combination with spinal anesthesia. This is study that consists of two groups: standard of care general anesthesia with a nerve block and a spinal anesthesia with nerve block. Patients are randomized to either of the two groups. There will be 71 patients enrolled in each group for this study.

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 study team or your doctor.

What data supports the effectiveness of the treatment General Anesthetic, SA + ESP for lumbar surgery?

Research shows that spinal anesthesia (SA) can be a safe and effective alternative to general anesthesia (GA) for lumbar spine surgery, especially in high-risk and elderly patients. Studies indicate that SA may lead to shorter anesthesia times, reduced pain, and fewer complications compared to GA. ^{1 2 3 4 5}

Is spinal anesthesia safe for lumbar spine surgery?

Spinal anesthesia is generally considered safe for lumbar spine surgery, even in high-risk and elderly patients, and it may reduce complications compared to general anesthesia. However, there is a risk of needing to switch to general anesthesia during the procedure if spinal anesthesia fails. ^{3 4 5 6 7}

How does the treatment General Anesthetic, SA + ESP differ from other treatments for lumbar surgery?

This treatment combines general anesthesia with spinal anesthesia and an erector spinae plane (ESP) block, which may offer benefits like reduced anesthesia time and suitability for high-risk patients who cannot undergo general anesthesia alone. It provides an alternative to the more commonly used general anesthesia by potentially improving recovery times and reducing complications. ^{1 3 4 8 9}

Eligibility Criteria

This trial is for adults aged 18-80 who need lumbar decompression surgery due to conditions like slipped disc or radiculopathy. Candidates must be able to consent and follow the study protocol, having one or two-level spine surgeries such as microdiscectomy. Those with morbid obesity, allergies to anesthetics used in the study, or involved in other drug trials are excluded.

Inclusion Criteria

I am between 18 and 80 years old.

I've had spine surgery, but only at different levels than my current issue.

Able to provide informed consent

Exclusion Criteria

I will need a drain after my upcoming surgery.

I am not allergic to any medications used in this study.

My BMI is over 35.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo lumbar decompression surgery with either spinal anesthesia or general anesthesia, combined with an erector spinae plane block

Intraoperative

1 visit (in-person)

Postoperative Monitoring

Participants are monitored for opioid consumption, anesthetic time, complications, and surgical duration

24 hours postoperatively

Follow-up

Participants are monitored for safety and effectiveness after treatment, including QoR15 and NRS survey assessments

2 weeks

1 visit (in-person)

Treatment Details

Interventions

• General Anesthetic
• SA + ESP

Trial Overview The trial aims to find the best anesthesia method for lumbar surgery by comparing general anesthesia with a nerve block (GA + ESP) against spinal anesthesia with a nerve block (SA + ESP). Participants will be randomly assigned into two groups of 71 each to receive either standard care or the new combination.

Participant Groups

Group I: SA + ESP Block Experimental Treatment 1 Intervention

Spinal Anesthesia: Patients will be provided with iv sedation, if desired, to facilitate placement of spinal anesthetic. Midazolam (2-5mg, iv), ketamine (up to 20 mg, lv) and/or propofol (0.1-0.2 mg/kg) will be permitted.

Group II: GA + ESP Block Active Control 1 Intervention

General anesthesia: induction of general anesthesia to facilitate endotracheal intubation: fentanyl (up to 2μg.kg.min-1), propofol (1-2 mg.kg-1), vecuronium (1-2 mg.kg-1).

Who Is Running the Clinical Trial?

Hospital for Special Surgery, New York

Lead Sponsor

Trials

257

Recruited

61,800+

Findings from Research

Spinal anesthesia (SA) was found to be a safe and effective alternative to general anesthesia in 18 high-risk patients undergoing lumbar spine surgery, with no anesthetic or surgical complications reported.

Patients experienced excellent postoperative pain relief, low incidence of nausea (11.11%), and high satisfaction levels, while also benefiting from lower costs compared to general anesthesia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lumbar Spine Surgeries Under Spinal Anesthesia in High-Risk Patients: A Retrospective Analysis. Patil, H., Garg, N., Navakar, D., et al.[2023]

References

1. Germany pubmed.ncbi.nlm.nih.gov

[Significantly shorter anesthesia time for surgery of the lumbar spine : process analytical comparison of spinal anesthesia and intubation narcosis]. [2022]

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

Spinal versus general anesthesia for minimally invasive transforaminal lumbar interbody fusion: implications on operating room time, pain, and ambulation. [2021]

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

Lumbar Spine Surgeries Under Spinal Anesthesia in High-Risk Patients: A Retrospective Analysis. [2023]

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

Spinal anesthesia in contemporary and complex lumbar spine surgery: experience with 343 cases. [2023]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Spinal Anesthesia for Geriatric Lumbar Spine Surgery: A Comparative Case Series. [2020]

6. Korea (South) pubmed.ncbi.nlm.nih.gov

Spinal anesthesia in elective lumbar spinal surgery. [2023]

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

A Second Prone Dose Algorithm for Patients Undergoing Spinal Anesthesia During Thoracolumbar Surgeries. [2023]

8. Scotland pubmed.ncbi.nlm.nih.gov

Assessment of surgeons' attitude towards awake spine surgery under spinal anesthesia. [2023]

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

Influence of baricity on the outcome of spinal anesthesia with bupivacaine for lumbar spine surgery. [2013]