ESP Block for Spinal Surgery

Overseen By Sheeraz Qureshi, MD, MBA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Hospital for Special Surgery, New York

Must not be taking: Opioids

Disqualifiers: BMI >40, Previous lumbar surgery, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 1 day

48 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether an erector spinae plane (ESP) block, a pain management technique, can improve outcomes for individuals undergoing minimally invasive lumbar spine surgery. Participants will be randomly assigned to one of two groups: one receiving the ESP block and the other not receiving it. The study aims to determine if the ESP block affects recovery and pain management after surgery. It suits individuals scheduled for minimally invasive spinal fusion surgery who have not had previous lumbar surgery and do not rely on daily opioid use. As an unphased trial, it offers participants the chance to contribute to innovative pain management research.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you are using opioids daily for more than 3 months, you would not be eligible to participate.

What prior data suggests that the ESP block is safe for spinal surgery?

Research has shown that the erector spinae plane (ESP) block is generally safe for individuals undergoing spinal surgery. Studies have found that ESP blocks reduce post-surgery pain and decrease the need for painkillers like opioids. Using fewer opioids often results in fewer side effects, such as nausea or drowsiness.

In one study, patients who received an ESP block experienced less nausea and vomiting after surgery. Another study found that it reduced pain and the need for medication during and after surgery, suggesting that the ESP block is well-tolerated.

For those considering joining a trial, these findings can be reassuring. The ESP block is not new and has been well-studied for safety in spinal surgeries. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using the erector spinae plane (ESP) block for spinal surgery because it offers a new approach to pain management. Unlike traditional options like general anesthesia or opioid-based pain relief, the ESP block targets nerves near the spine directly, potentially providing more localized pain control. This method could reduce the need for opioids, which have significant side effects and addiction risks. Additionally, the ESP block might offer faster pain relief and recovery, making the surgical experience smoother for patients.

What evidence suggests that the ESP block is effective for spinal surgery?

Research has shown that the erector spinae plane (ESP) block, which participants in this trial may receive, can effectively reduce pain after spinal surgery. In one study, patients who received the ESP block reported less pain during the first three days after their surgery. Another study found that the ESP block decreased the need for opioids (strong painkillers) within 24 hours after surgery. Additionally, patients felt more satisfied and experienced less nausea after receiving the ESP block. Overall, these findings suggest that the ESP block is useful for managing pain after lower spine surgery. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

This trial is for adults aged 18-80 who are scheduled to undergo minimally invasive surgery for spinal stenosis. Participants should be in a stable health condition, classified as ASA 1, 2, or 3 by anesthesiologists.

Inclusion Criteria

My health is good to moderately impaired.

I am scheduled for a minimally invasive spine surgery with the principal investigator.

Exclusion Criteria

Chronic opioid use (daily use for > 3 months)

Non-English speaking

I have had previous surgery on my lower back.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Preoperative Assessment

Preoperative patient demographics, comorbidities, history of opioid use, and operative details will be obtained

1 week

Treatment

Patients undergo minimally invasive transforaminal lumbar interbody fusion with or without ESP block

1 day

1 visit (in-person)

Postoperative Monitoring

Comprehensive assessment of opioid utilization, postoperative pain, non-opioid pain medication use, and opioid-induced complications

24 hours

Follow-up

Participants are monitored for safety and effectiveness after treatment, including time to opioid cessation and physical therapy clearance

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Erector spinae plane (ESP) block

Trial Overview

The study is testing the effectiveness of the Erector Spinae Plane (ESP) block compared to no ESP block in patients having minimally invasive spine surgery. It's a randomized controlled trial which means participants will be randomly assigned to one of the two groups.

How Is the Trial Designed?

Group I: ESP Block Experimental Treatment 1 Intervention

Patients assigned to the "ESP Block" arm will receive an ESP block prior to the surgery.

Group II: Control Active Control 1 Intervention

Patients assigned to the "Control" group will not receive an ESP block prior to the surgery.

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

The erector spinae plane (ESP) block provided over 50% pain relief for a 66-year-old man suffering from cervicothoracic junction pain due to a Pancoast tumor after just two sessions.

This regional anesthetic technique is shown to be convenient and safe, potentially reducing the need for opioids, although further research is necessary to assess the long-term safety and effectiveness of continuous ESP blocks in outpatient settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Erector Spinae Plane Block for the Treatment of Intractable Pain in a Patient with Pancoast Tumor: A Case Report. Rahimzadeh, P., Ahani, A., Antar, A., et al.[2023]

In a retrospective review of 182 patients, the erector spinae plane block (ESPB) was found to provide effective postoperative pain relief when used as part of a multimodal analgesia plan.

The study noted few complications associated with ESPB, highlighting its safety as a regional anesthesia technique for various thoracoabdominal pain indications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ultrasound-guided Erector Spinae Plane Block: Indications, Complications, and Effects on Acute and Chronic Pain Based on a Single-center Experience. Tulgar, S., Selvi, O., Senturk, O., et al.[2020]

The erector spinae plane block (ESPB) significantly reduces opioid consumption after surgeries such as breast, thoracic, and vertebral surgeries, indicating its effectiveness in postoperative pain management.

ESPB is a promising analgesic technique compared to no block and some alternative blocks, although it performed less effectively than the PECS block for breast surgery, highlighting the need for further refinement and understanding of its mechanism.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The opioid sparing effect of erector spinae plane block for various surgeries: a meta-analysis of randomized-controlled trials. Fanelli, A., Torrano, V., Cozowicz, C., et al.[2022]

Erector spinae plane block (ESPB) significantly reduces opioid consumption and pain scores after lumbar spine surgery, with a study of 980 patients showing a marked decrease in opioid use within the first 24 hours post-surgery.

Patients receiving ESPB reported higher satisfaction levels and experienced a longer time before needing additional pain relief, indicating that ESPB is both effective and safe for postoperative analgesia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of Postoperative Analgesia by Erector Spinal Plane Block after Lumbar Surgery: A Systematic Review and Meta-analysis of Randomized Controlled Trials. Xiao, X., Zhu, T., Wang, L., et al.[2022]

Pre-operative bilateral erector spinae plane block (ESPB) significantly improved recovery after posterior lumbar surgery, as indicated by higher alertness scores (MOAA/S) at 10 minutes post-extubation compared to the control group.

Patients receiving the ESPB required less intraoperative and postoperative opioid medication, leading to reduced opioid consumption and quicker ambulation after surgery, highlighting its efficacy in pain management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bilateral Erector Spinae Plane Blocks for Open Posterior Lumbar Surgery. Zhang, TJ., Zhang, JJ., Qu, ZY., et al.[2022]

The Erector Spinae Plane Block (ESPB) is a new technique for pain management that involves injecting local anesthetic between the erector spinae muscle and the transverse process, which has been generally considered safe.

Despite its safety profile, there is a potential for complications, as demonstrated by a case where a patient developed priapism following the ESPB, highlighting the need for careful monitoring as the technique becomes more widely used.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Priapism following erector spinae plane block for the treatment of a complex regional pain syndrome. Elkoundi, A., Eloukkal, Z., Bensghir, M., et al.[2019]

In a study involving patients undergoing thoracotomy, a 30 ml dose of bupivacaine for the erector spinae plane block (ESPB) provided significantly better pain relief compared to a 20 ml dose, as indicated by lower visual analog scale (VAS) scores for both resting and coughing at multiple time points post-surgery.

Both doses of bupivacaine resulted in similar side effect rates, suggesting that the 30 ml dose is not only more effective for pain management but also safe for use in this patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of analgesic efficacy of different local anesthetic volumes for erector spinae plane block in thoracotomy patients; a prospective randomized trial. Zengin, M., Sazak, H., Baldemir, R., et al.[2023]

The Erector Spinae Plane Block (ESPB) is an effective ultrasound-guided technique for managing postoperative pain, particularly in the thoracic and abdominal areas.

This study highlights the successful use of a fluoroscopic-guided ESPB specifically for lower back spinal surgery, suggesting its versatility and potential benefits in pain management for this type of procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fluoroscopic-guided erector spinae plane block for spine surgery. Kim, E., Alshoubi, A.[2022]

The erector spinae plane block (ESP) effectively spreads anesthetic over multiple dermatomal levels (T6 to T9 on one side and T9 to T11/12 on the other) in a neonatal cadaver, indicating its potential for effective pain management in truncal surgeries.

This technique allows for analgesia without affecting the epidural space, suggesting it can be a safe and versatile option in multimodal postoperative pain strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The extent of cranio-caudal spread within the erector spinae fascial plane space using computed tomography scanning in a neonatal cadaver. Govender, S., Mohr, D., Van Schoor, AN., et al.[2021]

Larger volumes of injectate in erector spinae plane (ESP) blocks lead to greater spread of anesthetic, with 30-40 mL achieving coverage across 4-7 spinal levels, while 60-80 mL resulted in even more extensive spread.

The study found that while increased volume improved cephalocaudal spread, there was no dye spread to critical structures like the epidural space or pleura, suggesting a safe profile for ESP blocks in providing analgesia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Relationship between injectate volume and disposition in erector spinae plane block: a cadaveric study. Gadsden, J., Gonzales, J., Chen, A.[2023]

The erector spinae plane (ESP) block effectively spreads analgesic dye from the T1 to T11 levels in the dorsal region, indicating its potential for broad pain control in the thoracic area.

Importantly, the study found no diffusion of the contrast solution into the anterior region or paravertebral space, suggesting a targeted mechanism of action that minimizes the risk of affecting surrounding structures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Anatomical evaluation of the extent of spread in the erector spinae plane block: a cadaveric study. Aponte, A., Sala-Blanch, X., Prats-Galino, A., et al.[2022]

In a study of 342 patients undergoing lumbar spine surgery, ultrasound-guided erector spinae plane blocks (ESPB) showed no complications directly related to the procedure, highlighting its safety profile.

The incidence of poorly controlled pain (NRS ≥7) in the post-anesthesia care unit was low at 5%, indicating that ESPB may effectively manage postoperative pain without significant adverse effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Procedure-Specific Complications Associated with Ultrasound-Guided Erector Spinae Plane Block for Lumbar Spine Surgery: A Retrospective Analysis of 342 Consecutive Cases. Oezel, L., Hughes, AP., Onyekwere, I., et al.[2022]

The erector spinae plane (ESP) block significantly reduces pain scores in the first 48 hours after lumbar spine surgery, both at rest and during activity, based on a systematic review of 22 randomized controlled trials involving 1,327 patients.

Using the ESP block also leads to decreased opioid consumption and fewer patients needing rescue analgesics, which contributes to lower rates of postoperative nausea and vomiting and higher patient satisfaction scores.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Erector Spinae Plane Block on Postoperative Pain and Opioid Consumption After Lumbar Spine Surgery: A Systematic Review and Meta-analysis of Randomized Controlled Trials. Wilson, AA., Schmid, AM., Pestaña, P., et al.[2023]

The study found that both the erector spinae plane (ESP) block and paravertebral block (PVB) significantly reduced morphine consumption compared to a control group in 75 patients undergoing breast surgery, indicating effective postoperative pain management.

There was no significant difference in analgesic effectiveness between the ESP and PVB groups, suggesting that ESP block can be a viable alternative to PVB for postoperative pain relief.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Erector spinae plane block and thoracic paravertebral block for breast surgery compared to IV-morphine: A randomized controlled trial. Gürkan, Y., Aksu, C., Kuş, A., et al.[2021]

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