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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the best type of anesthesia for lumbar spine surgery. It compares general anesthesia (which puts patients to sleep completely) with spinal anesthesia (which numbs the lower body) to determine which reduces pain and the need for painkillers afterward. Participants will randomly receive either general anesthesia with a nerve block or spinal anesthesia with a nerve block during surgery. The trial seeks individuals who have undergone one or two levels of specific spine procedures, such as microdiscectomy, and who can understand and follow the study guidelines. As a Phase 3 trial, this research represents the final step before FDA approval, offering participants a chance to contribute to a potentially groundbreaking treatment.

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.

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

Research has shown that spinal anesthesia with an erector spinae plane (ESP) block is generally safe for back surgeries. Studies have found that this method effectively reduces post-surgery pain and decreases the need for opioids, which can cause side effects like nausea.

Feedback from previous patients indicates that this type of anesthesia can lower pain levels and reduce blood loss during surgery. These studies have reported no major safety issues.

General anesthesia, the other option in this study, is a well-established and safe method for spine surgeries. It remains the standard approach currently used. In summary, past research has shown that both anesthesia options in this trial are safe. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it compares two anesthesia techniques for lumbar surgery: spinal anesthesia (SA) combined with an erector spinae plane (ESP) block, and general anesthesia (GA) with an ESP block. Unlike traditional general anesthesia, which requires deep sedation and endotracheal intubation, the SA + ESP approach may offer a more targeted anesthetic effect with potentially fewer systemic side effects. This method allows for the use of lighter sedatives, such as midazolam and ketamine, which can result in a quicker recovery time and reduced risk of respiratory complications. By exploring these differences, the trial aims to determine which method offers better outcomes for patients, potentially leading to more personalized and effective anesthesia strategies for lumbar surgery.

What evidence suggests that this trial's anesthetic methods could be effective for lumbar surgery?

Research has shown that spinal anesthesia with an erector spinae plane (ESP) block can be highly effective for back surgery. In this trial, some participants will receive spinal anesthesia with an ESP block. Studies have found that the ESP block reduces the need for opioids, such as fentanyl, after surgery. For instance, one study noted a significant drop in fentanyl use during the first 24 hours post-surgery. Patients also reported less pain and greater satisfaction. Additionally, the ESP block was associated with less nausea after surgery. These findings suggest that spinal anesthesia with an ESP block could be a promising option for managing pain in back surgeries. Meanwhile, other participants in this trial will receive general anesthesia with an ESP block, allowing for a comparison of outcomes between the two approaches. ^{2 5 6 7 8}

Are You a Good Fit for This Trial?

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

Able to provide informed consent

Able to follow study protocol

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11218203/

The efficacy of lumbar erector spinae plane block for ... The findings indicated that ESPB was more successful in reducing 24-h postoperative fentanyl usage (89.9 ± 65.3 mcg vs. 150.3 ± 120.9 mcg) ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S0952818022000034

Analgesic efficacy of erector spinae plane block in lumbar ... ESPB improved analgesic efficacy by reducing opioid consumption 24 h after surgery. •. ESPB increased patient satisfaction and decreased postoperative nausea ...

3. nature.com nature.com/articles/s41598-025-03958-w

A randomized clinical trial of erector spinae plane block ... The primary hypothesis of this study was that ESPB reduces the incidence of chronic pain for 3 months after posterior lumbar surgery.

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/30424594/

Efficacy of the Erector Spinae Plane Block for Lumbar ... Conclusions: The ESP block provides effective postoperative analgesic effect for 24 hours in patients undergoing lumbar spinal surgery. Keywords ...

5. frontiersin.org frontiersin.org/journals/medicine/articles/10.3389/fmed.2024.1330446/full

Efficacy of erector spine plane block in two different ... Conclusion: ESPB significantly reduced pain at rest after surgery, the number of patients requiring immediate postoperative fentanyl analgesia, and total ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10164397/

Efficacy and Safety of Erector Spinae Plane Block ... This meta-analysis demonstrated that ESPB used in lumbar spinal surgery was effective in relieving postoperative pain, decreasing the perioperative consumption ...

7. nature.com nature.com/articles/s41598-025-13518-x

Effects of erector spinae plane block on intraoperative ... ESPB was associated with a significant reduction in IBPV and intraoperative blood loss without extending surgical time. Additionally, ESPB ...

8. journals.lww.com journals.lww.com/anesthesia-analgesia/fulltext/9900/erector_spinae_plane_block_in_multimodal_analgesia.1352.aspx

Erector Spinae Plane Block in Multimodal Analgesia After... This study evaluated the effect of bilateral ESPB on early postoperative pain and opioid use after lumbar spinal fusion surgery.