Erector Spinae Plane Block for Scoliosis

N/A

Waitlist Available

Led By Jordan Ruby, MD

Research Sponsored by Hospital for Special Surgery, New York

Eligibility Criteria Checklist

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

Must have

Be younger than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, an average of 1 year

Summary

This trial will help determine if the ultrasound-guided Erector Spinae Plane Block (ESPB) can help reduce patients' pain levels and need for opioid medication during and after pediatric spinal fusion surgery.

Who is the study for?

Adolescents aged 10-19 with adolescent idiopathic scoliosis undergoing spinal fusion surgery can join this trial. They must be under the care of participating surgeons and speak English. Excluded are those with neuromuscular scoliosis, chronic opioid therapy or pain conditions requiring certain medications, allergies to study drugs, or non-English speakers.

What is being tested?

The trial is testing if an Erector Spinae Plane Block (ESPB), which involves injecting a mix of bupivacaine and dexamethasone into back muscles, reduces pain and opioid use after pediatric spinal fusion surgery for scoliosis compared to no ESPB.

What are the potential side effects?

Possible side effects from the ESP block may include discomfort at injection site, potential nerve damage, allergic reactions to bupivacaine or dexamethasone, and less commonly infection or bleeding where the drug was injected.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, an average of 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, an average of 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 1 year for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Number of patients who receive bilateral, pre-incision ESPB

Secondary study objectives

Attrition

Blinding Assessment

Incidence of intra- and postoperative complications attributed to ESPB

+7 more

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: ESPB with Bupivacaine and DexamethasoneActive Control1 Intervention

12 pediatric spinal fusion surgery patients will be randomized to receive intraoperative ultrasound-guided bilateral ESPB with 0.25% bupivacaine with 2mg preservative free dexamethasone with a maximum of 30 mL total per side, depending on the patient's weight.

Group II: No ESPBPlacebo Group1 Intervention

12 pediatric spinal fusion surgery patients will be randomized to not receive an intraoperative ultrasound-guided bilateral ESPB. These patients will still receive the standard anesthesia regimen during and after surgery.

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