ESP Block for Scoliosis

Overseen By Ban Tsui, MD

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Stanford University

Must not be taking: Analgesics

Disqualifiers: Congenital scoliosis, Cardiac disease, Seizures, others

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

Compensation: Varies

Number of Visits: 1

Duration: 1 day

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to find a better way to manage pain after spinal fusion surgery for people with idiopathic scoliosis. It will test the effectiveness of a new pain relief method called the erector spinae plane block (an injection near the spine) compared to the usual opioid-based pain management. Patients diagnosed with idiopathic scoliosis undergoing a single-stage spinal fusion may be suitable candidates for this trial. The goal is to reduce pain without the side effects associated with opioids. As an unphased trial, this study provides patients the opportunity to explore innovative pain management options beyond traditional methods.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but if you are on regular pain medications, you may not be eligible to participate.

What prior data suggests that the erector spinae plane blockade is safe for pediatric scoliosis surgery?

Research shows that the erector spinae plane block (ESPB) holds promise for managing pain after scoliosis surgery. Studies have found that ESPB effectively reduces pain and decreases the need for opioids, which are pain-relieving drugs with many side effects. Importantly, ESPB does not affect movement.

Other research indicates that ESPB is safe during spinal surgery. It does not interfere with critical monitoring, such as checking nerve signals during the procedure, which is crucial for patient safety.

Overall, the evidence suggests that ESPB is well-tolerated and safe. It offers a potential option for managing pain with fewer side effects than traditional painkillers. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Erector Spinae Plane (ESP) Blockade is unique because it offers a new way to manage pain for scoliosis surgery without relying heavily on opioids. Unlike most standard treatments that use a combination of medications, including opioids, the ESP Blockade involves an injection that numbs specific nerves in the back, potentially reducing the need for opioids and their side effects. Researchers are excited about this treatment because it could provide effective pain relief while minimizing the risk of opioid-related complications, making recovery easier and safer for patients.

What evidence suggests that the erector spinae plane blockade is effective for scoliosis?

Studies have shown that the erector spinae plane block (ESPB) effectively relieves pain after spinal surgery. In this trial, some patients undergoing scoliosis surgery will receive the ESPB, which reduces the need for opioids—strong pain medications with many side effects. Research indicates that ESPB helps control pain and reduces the body's stress response to surgery. Additionally, ESPB does not affect muscle movement, so it doesn't cause weakness. Overall, ESPB offers a promising way to manage pain with fewer side effects than traditional pain medications. ^{1 2 3 4 5}

Are You a Good Fit for This Trial?

This trial is for children with idiopathic scoliosis who are undergoing a single-stage spinal fusion surgery. They should be generally healthy (ASA I-III) and within the normal weight range for their age. It's not suitable for those with developmental issues, severe organ dysfunction, pre-existing pain conditions, psychiatric diagnoses like anxiety or depression, allergies to lidocaine, seizure history, or if they need intensive care after surgery.

Inclusion Criteria

I have been diagnosed with idiopathic scoliosis.

ASA I-III

I am having a one-time back surgery to fuse and stabilize my spine.

Exclusion Criteria

I have scoliosis due to a birth defect or muscle condition.

My surgery is not planned in stages.

I regularly take pain medication for ongoing pain issues.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive an erector spinae plane blockade prior to their scoliosis surgery as part of the standard regional anesthesia technique

1 day

1 visit (in-person)

Postoperative Monitoring

Participants are monitored for opioid consumption, mobility, lidocaine plasma concentration, and pain scores during their hospital stay

5 days

Daily monitoring during hospital stay

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Erector Spinae Plane Blockade

Trial Overview

The study tests the effectiveness of Erector Spinae Plane Blockade (ESPB), which involves injecting local anesthetic near the spine muscles to manage pain post-scoliosis surgery. The goal is to see if ESPB can reduce reliance on opioids and better control inflammation-related acute pain without causing muscle weakness.

How Is the Trial Designed?

Group I: Erector Spinae Plane Blockade Treatment Experimental Treatment 1 Intervention

Patients will receive an erector spinae plane blockade prior to their surgery as per standard regional anesthesia technique.

Group II: Erector Spinae Plane Blockade Control - Standard of Care Active Control 1 Intervention

Patients will receive the standard of care for pediatric scoliosis surgery including multi-modal opioid pain management. If the patient declines to consent to enrollment into the randomized study, patients may still participate by allowing prospective data and samples collection/analysis with respect to perioperative choice.

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials

2,527

Recruited

17,430,000+

Published Research Related to This Trial

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 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]

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]

The study found that an ultrasound-guided erector spinae plane (ESP) block using 20 mL of 0.5% bupivacaine resulted in a mean dermatomal spread of 9 dermatomes, effectively providing pain relief for patients with acute thoracic pain.

Sixteen out of eighteen patients experienced significant pain relief, with Visual Analog Scale (VAS) scores improving by at least 50% and high patient satisfaction reported, indicating the ESP block is both effective and safe with no major complications observed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of Sensory Mapping of Erector Spinae Plane Block. Barrios, A., Camelo, J., Gomez, J., et al.[2020]

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 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]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11232938/

Effectiveness of the Bilateral and Bilevel Erector Spinae ...

ESPB is effective for postoperative analgesia, can reduce opioid consumption in patients undergoing scoliosis surgery, and reduces the stress response to ...

2.

clinicaltrials.gov

clinicaltrials.gov/study/NCT04500613

Erector Spinae Plane Blocks for Adolescent Idiopathic ...

The present study is designed to be the first randomized controlled trial to evaluate the role of ESPB in pediatric spinal fusion surgery and the role of ESPB ...

3.

trialsjournal.biomedcentral.com

trialsjournal.biomedcentral.com/articles/10.1186/s13063-024-08331-2

The effect of bilateral ultrasound-guided erector spinae plane ...

This study focuses on the effect of ESPB on pediatric patients undergoing PSF on postoperative pain control and intends to provide a new strategy of multimodal ...

4.

trials.arthritis.org

trials.arthritis.org/trials/NCT04500613

Erector Spinae Plane Blocks for Adolescent Idiopathic Scoliosis

One technique that can potentially reduce patients' pain levels and need for opioid medication is the ultrasound-guided Erector Spinae Plane Block (ESPB). The ...

5.

tandfonline.com

tandfonline.com/doi/full/10.1080/11101849.2024.2361386

Full article: The impact of erector spinae plane (ESP) block ...

The ESP block can be safely used without interfering with the monitoring of the somatosensory and MEPs during complex spinal surgery.