What side effects are associated with this type of intervention?

The Erector Spinae Plane Block (ESPB) for scoliosis involves injecting a local anesthetic between the erector spinae muscle and the transverse process. Common side effects include injection site pain, temporary numbness, and rare risks of infection or allergic reactions. There is also a potential for incomplete pain relief or motor blockade, although motor blockade is less common with ESPB compared to other regional anesthesia techniques.

What prior FDA approvals exist?

There are no specific FDA approvals for the Erector Spinae Plane Block (ESPB) for the treatment of scoliosis. However, the use of local anesthetics in regional anesthesia techniques, such as epidural and spinal anesthesia, is well-established and FDA-approved for various types of pain management, including postoperative pain. These techniques are similar in that they involve the administration of local anesthetics to manage pain, but they differ in the specific anatomical targets and methods of administration.

What other types of research exist?

Promising novel alternatives to the Erector Spinae Plane Block for scoliosis patients include: 1) Multimodal analgesia protocols incorporating systemic opioid-sparing analgesics such as gabapentinoids, which have shown efficacy in reducing postoperative pain. 2) Ultrasound-guided regional blocks like the Quadratus Lumborum Block, which targets the thoracolumbar fascia and has been effective in managing postoperative pain without significant motor blockade. 3) Continuous peripheral nerve blocks, such as the Paravertebral Block, which provides prolonged analgesia and can be tailored to the specific surgical site. These alternatives offer effective pain control with potentially fewer side effects compared to traditional opioid-based regimens.

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Regional Anesthesia

ESP Block for Scoliosis

N/A

Recruiting

Research Sponsored by Stanford University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diagnosed with Idiopathic scoliosis

Undergoing single-stage posterior spinal instrumentation and fusion

Must not have

Congenital/neuromuscular scoliosis

Unplanned staged procedure

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through hospital stay, an average of 5 days

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new pain relief method called ESPB for children having spinal surgery for scoliosis. The ESPB numbs the area around the spine to reduce pain without causing muscle weakness. It aims to provide better pain control than current methods, which often have many side effects. The ESPB is a recently developed technique that has been successfully used for various types of surgeries, including thoracic, abdominal, and spine surgeries.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While specific side effects of ESPB in this context may not be well-documented yet due to its novelty, potential risks include discomfort at injection site, infection risk from needle insertion, possible allergic reactions to anesthetics used like lidocaine and rare nerve damage.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with idiopathic scoliosis.

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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My surgery is not planned in stages.

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I regularly take pain medication for ongoing pain issues.

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I have porphyria.

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I have a history of seizures.

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I have a known heart, kidney, or liver condition.

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I need to be admitted to the Pediatric Intensive Care Unit.

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I need special pain management after surgery.

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I have a diagnosed psychiatric condition like anxiety or depression.

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My weight is either below the 5th percentile or above the 85th percentile for my age.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through hospital stay, an average of 5 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through hospital stay, an average of 5 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and through hospital stay, an average of 5 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Inpatient Postoperative Mobility

Length of Stay (LOS)

Maximum lidocaine plasma concentration [Cmax]

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Erector Spinae Plane Blockade TreatmentExperimental Treatment1 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 CareActive Control1 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.

0 / 12Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The Erector Spinae Plane Block (ESPB) involves the injection of a local anesthetic between the erector spinae muscle and the transverse process of the vertebrae. This technique provides effective analgesia by blocking the dorsal and ventral rami of the spinal nerves, which helps in managing postoperative pain without causing motor blockade. Other common treatments for scoliosis include bracing, which mechanically supports the spine to prevent further curvature, and surgical interventions like spinal fusion, which stabilize the spine by fusing vertebrae together. Understanding these mechanisms is crucial for scoliosis patients as it helps them make informed decisions about pain management and treatment options, potentially improving their quality of life and treatment outcomes.

Manipulation under anesthesia combined with epidural steroid injection.Continuous erector spinae plane block versus thoracic epidural analgesia in video-assisted thoracic surgery: a study protocol for a prospective randomized open label non-inferiority trial.