Erector Spinae Plane Block for Back Pain

Overseen By Michelle Santangelo, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Rush University Medical Center

Disqualifiers: Non-English/Spanish, Incarceration, Pregnancy, Allergies, Critical illness, others

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

Compensation: Varies

Number of Visits: 4

Duration: 1 day

62 Participants Needed

Trial Summary

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.

What data supports the effectiveness of the treatment Erector Spinae Plane Block for back pain?

Research shows that the Erector Spinae Plane Block can help reduce pain and the need for opioids (strong painkillers) after lumbar spine surgeries, suggesting it might also be effective for back pain. ^{1 2 3 4 5}

Is the Erector Spinae Plane Block generally safe for humans?

The Erector Spinae Plane Block is generally considered to have a favorable safety profile, but complications like priapism (a prolonged erection) and potential systemic toxicity have been reported. Large studies suggest few complications, but as its use increases, more side effects may be identified. ^{2 6 7 8 9}

How is the erector spinae plane block treatment different from other treatments for back pain?

The erector spinae plane block is unique because it involves injecting a local anesthetic between muscle layers in the back to target the origin of spinal nerves, providing pain relief. This technique is relatively new and can be guided by ultrasound or fluoroscopy, making it a versatile option for managing both acute and chronic pain. ^{3 10 11 12 13}

What is the purpose of this trial?

The goal of this clinical trial is to learn if an erector spinae plane block (ESPB; a type of nerve block) works to reduce pain in adults presenting to the emergency department with low back pain. It will also learn if the ESPB reduces pain, disability, and return to work at 7 days. The main questions it aims to answer are: 1. Does the ESPB reduce short-term pain in participants with low back pain? 2. Does the ESPB reduce longer-term pain, reduce disability, and improve return to work and activities in participants with low back pain? Researchers will compare ESPB to a placebo (an injection that does not involve a nerve block) to see if ESPB works to treat low back pain. Participants will: Receive either the ESPB or a placebo injection in the emergency department Report their pain scores for up to 120 minutes Report their pain, disability, and return to work at 7 days

Research Team

Michael Gottlieb, MD

Principal Investigator

Rush University Medical Center

Eligibility Criteria

This trial is for adults over 18 who come to the emergency department with low back pain that's been there for less than six weeks. It's not specified, but typically people with certain health conditions or those on conflicting medications might be excluded.

Exclusion Criteria

Are incarcerated

Have a known pregnancy

Are allergic to amide-type local anesthetics

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1 day

1 visit (in-person)

Treatment

Participants receive either the ESPB or a placebo injection in the emergency department

1 day

1 visit (in-person)

Immediate Follow-up

Participants report their pain scores for up to 120 minutes post-intervention

120 minutes

1 visit (in-person)

Follow-up

Participants report their pain, disability, and return to work at 7 days

7 days

1 visit (virtual or in-person)

Treatment Details

Interventions

• Erector Spinae Plane Block

Trial Overview The study is testing if an erector spinae plane block (ESPB), a type of nerve block, can reduce acute and longer-term low back pain compared to a sham procedure (placebo injection). Participants will report their pain up to two hours after treatment and again at seven days.

Participant Groups

Group I: Erector Spinae Plane Block Experimental Treatment 1 Intervention

This group will receive the erector spinae plane block

Group II: Sham Procedure Placebo Group 1 Intervention

This group will receive a sham injection.

Who Is Running the Clinical Trial?

Rush University Medical Center

Lead Sponsor

Trials

448

Recruited

247,000+

Findings from Research

The erector spinae plane (ESP) block significantly reduced postoperative fentanyl consumption and pain scores (VAS) at one hour after lumbar herniated disc surgery, indicating effective pain management shortly after the procedure.

Patients receiving the ESP block did not require intraoperative opioids, suggesting that this technique may enhance overall opioid-sparing strategies during surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Is Opioid-free Anesthesia Possible by Using Erector Spinae Plane Block in Spinal Surgery? Taşkaldıran, Y.[2021]

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 erector spinae plane (ESP) block effectively distributes local anesthetic, as shown by the presence of methylene blue in multiple intercostal spaces and the paravertebral space, indicating its potential for pain management.

The exact pathway through which the anesthetic travels from the posterior to the anterior thorax remains unclear, suggesting that further research is needed to fully understand the mechanism of action of the ESP block.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Erector spinae plane block: A cadaver study to determine its mechanism of action. Vidal, E., Giménez, H., Forero, M., et al.[2022]

In a study of 84 patients undergoing posterior lumbar interbody fusion, preoperative bilateral erector spinae plane blocks significantly improved the quality of recovery 24 hours post-surgery, with a median score difference of 9 compared to the control group.

The erector spinae plane blocks also reduced pain scores, delayed the need for rescue analgesia, decreased morphine consumption, and lowered the incidence of postoperative nausea and vomiting, all without any reported adverse events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bilateral Erector Spinae Plane Block for Quality of Recovery Following Posterior Lumbar Interbody Fusion: A Randomized Controlled Trial. Lin, H., Guan, J., Luo, S., et al.[2023]

The erector spinae plane block (ESPB) was successfully used to treat a 52-year-old woman with chronic radicular left arm pain in the emergency department, demonstrating its potential effectiveness for upper extremity pain management.

Using ESPB can help avoid the risks associated with opioid use and preserve motor function, making it a safer alternative to traditional pain management methods like brachial plexus blockade.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Erector Spinae Plane Block in the Emergency Department for Upper Extremity: A Case Report. Lee, DH., Martel, ML., Reardon, RF.[2021]

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 15 patients undergoing thoracic surgery, the use of erector spinae plane blocks with ropivacaine showed a mean peak concentration (Cmax) of 2.5 mg/L, with some patients reaching potentially toxic levels, although no severe neurological symptoms were reported.

To minimize the risk of local anesthetic systemic toxicity, it is recommended to use a weight-based dosing approach, suggesting a maximum dose of 2.5 mg/kg based on ideal body weight, and reducing the initial dose to 75 mg could lower the risk of toxicity to less than 1%.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Population pharmacokinetic and safety analysis of ropivacaine used for erector spinae plane blocks. Schwenk, ES., Lam, E., Abulfathi, AA., et al.[2023]

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]

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 is a promising technique for managing chronic thoracic pain, showing benefits such as reduced opioid use and longer time to first analgesic requirement, based on a qualitative review of four randomized controlled trials.

While the ESP block appears to be safe and effective, with some studies suggesting it can be as effective as epidural analgesia, further well-designed randomized controlled trials are necessary to fully understand its safety and efficacy compared to standard regional anesthesia techniques.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Erector spinae plane block: a systematic qualitative review. De Cassai, A., Bonvicini, D., Correale, C., et al.[2022]

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 (ESP) block is a safe and effective regional anesthesia technique that can provide pain relief for various surgical procedures, including breast, thoracic, and abdominal surgeries, as well as chronic pain management.

In a series of six cases, both continuous and single-shot ESP blocks demonstrated successful postoperative pain control, highlighting the versatility of this technique in different clinical scenarios.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Erector spinae plane block: Relatively new block on horizon with a wide spectrum of application - A case series. Jain, K., Jaiswal, V., Puri, A.[2020]

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]

References

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

Is Opioid-free Anesthesia Possible by Using Erector Spinae Plane Block in Spinal Surgery? [2021]

2. 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]

3. Spain pubmed.ncbi.nlm.nih.gov

Erector spinae plane block: A cadaver study to determine its mechanism of action. [2022]

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

Bilateral Erector Spinae Plane Block for Quality of Recovery Following Posterior Lumbar Interbody Fusion: A Randomized Controlled Trial. [2023]

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

Erector Spinae Plane Block in the Emergency Department for Upper Extremity: A Case Report. [2021]

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. England pubmed.ncbi.nlm.nih.gov

Population pharmacokinetic and safety analysis of ropivacaine used for erector spinae plane blocks. [2023]

8. 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]

9. 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]

10. Italy pubmed.ncbi.nlm.nih.gov

Erector spinae plane block: a systematic qualitative review. [2022]

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

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

12. India pubmed.ncbi.nlm.nih.gov

Erector spinae plane block: Relatively new block on horizon with a wide spectrum of application - A case series. [2020]

13. India pubmed.ncbi.nlm.nih.gov

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