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

Trial Summary

What is the purpose of this trial?

This is a prospective, randomized controlled trial of patients undergoing minimally invasive transforaminal lumbar interbody fusion. This study will randomize patients into one of two groups: erector spinae plane (ESP) block and no ESP block.

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 data supports the effectiveness of the treatment Erector Spinae Plane Block (ESPB) for spinal surgery?

Research shows that the Erector Spinae Plane Block (ESPB) is effective in managing pain after lumbar spine surgeries and can enhance recovery. It has been compared to other pain management techniques and is gaining importance for its simplicity and effectiveness in reducing postoperative pain. ^{1 2 3 4 5}

Is the erector spinae plane block (ESPB) generally safe for humans?

The erector spinae plane block (ESPB) is generally considered safe, with few complications reported in large studies, although rare side effects like priapism (a prolonged erection) have been noted. ^{6 7 8 9 10}

How does the ESP Block treatment for spinal surgery differ from other treatments?

The ESP Block is unique because it is a regional anesthesia technique that involves injecting a local anesthetic below the erector spinae muscle, which can effectively block nerves in the area of spinal surgery. This method is different from traditional pain management techniques like paravertebral and epidural blocks, as it offers a novel approach to pain control with potentially fewer complications. ^{3 11 12 13 14}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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 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]

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 (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 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 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]

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 (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]

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]

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]

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]

References

1. United States 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. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Relationship between injectate volume and disposition in erector spinae plane block: a cadaveric study. [2023]

3. New Zealand pubmed.ncbi.nlm.nih.gov

Bilateral Erector Spinae Plane Blocks for Open Posterior Lumbar Surgery. [2022]

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

Erector spinae plane block and thoracic paravertebral block for breast surgery compared to IV-morphine: A randomized controlled trial. [2021]

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

Fluoroscopic-guided erector spinae plane block for spine surgery. [2022]

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

Priapism following erector spinae plane block for the treatment of a complex regional pain syndrome. [2019]

7. New Zealand 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. [2022]

8. Italy pubmed.ncbi.nlm.nih.gov

The opioid sparing effect of erector spinae plane block for various surgeries: a meta-analysis of randomized-controlled trials. [2022]

9. United States 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. [2022]

10. England 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. [2023]

11. Netherlands pubmed.ncbi.nlm.nih.gov

Erector Spinae Plane Block for the Treatment of Intractable Pain in a Patient with Pancoast Tumor: A Case Report. [2023]

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

Anatomical evaluation of the extent of spread in the erector spinae plane block: a cadaveric study. [2022]

13. France 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. [2021]

14. United States 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. [2020]