What is the mechanism of action of this treatment?

The Erector Spinae Plane (ESP) Block is a regional anesthesia technique that involves injecting a local anesthetic near the erector spinae muscle to block pain signals at the spinal level, providing targeted pain relief for acute conditions like kidney stones. This method is beneficial as it offers effective pain control without the systemic side effects associated with oral or intravenous medications. Other common treatments include NSAIDs or opioids for pain management, which reduce inflammation or alter pain perception, and alpha-blockers that relax urinary tract muscles to facilitate stone passage. Understanding these mechanisms helps kidney stone patients and their healthcare providers select the most effective and least invasive pain management strategy, improving comfort and outcomes during stone passage.

What side effects are associated with this type of intervention?

Common treatments for kidney stones include extracorporeal shock wave lithotripsy (ESWL), ureteroscopy, and percutaneous nephrolithotomy (PCNL). ESWL can cause bruising, pain, and hematuria. Ureteroscopy may lead to urinary tract infections, ureteral injury, and bleeding. PCNL carries risks of infection, bleeding, and injury to surrounding organs. For regional anesthesia techniques like the Erector Spinae Plane (ESP) Block, side effects are generally mild and may include local pain at the injection site, temporary numbness, and, rarely, systemic toxicity if the anesthetic spreads to the bloodstream.

What prior FDA approvals exist?

The FDA has approved various treatments for kidney stones, primarily focusing on pain management and facilitating stone passage. While specific approvals for the Erector Spinae Plane (ESP) Block for kidney stones are not detailed, regional anesthesia techniques like nerve blocks are commonly used for pain relief in renal colic. Other FDA-approved medications for pain management in kidney stones include nonsteroidal anti-inflammatory drugs (NSAIDs) and opioids. Additionally, medications such as alpha-blockers (e.g., tamsulosin) are used to facilitate the passage of stones.

What other types of research exist?

Promising novel alternatives to the Erector Spinae Plane Block for kidney stone patients include: 1) Percutaneous Peripheral Nerve Stimulation (PNS), which involves the placement of a small electrical device near the nerves to modulate pain signals. 2) High-Volume Local Infiltration Analgesia (LIA), which combines local anesthetics with anti-inflammatory agents for prolonged pain relief. 3) Ultrasound-Guided Genicular Nerve Blocks, which have been explored for other types of pain and may offer targeted pain relief for renal colic.

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Local Anesthetic

ESP Block for Kidney Stones

Phase 4

Recruiting

Led By Michael Secko, MD

Research Sponsored by Stony Brook University

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 10 minutes after the esp block

Awards & highlights

Drug Has Already Been Approved

No Placebo-Only Group

Pivotal Trial

Summary

This trial compares standard care to a spinal injection for kidney stone pain. The injection aims to block pain signals and provide relief. Pain levels will be measured over time after the injection.

Who is the study for?

This trial is for adults aged 18 to 65 who are experiencing flank pain due to kidney stones and are in the emergency department. They should be generally healthy without serious heart, lung, liver, or kidney problems. Pregnant women and those with allergies to local anesthetics like Ropivacaine can't join. Also excluded are individuals with a history of spine issues or mental disease exacerbations.

What is being tested?

The study is examining if injecting Ropivacaine (an anesthetic) near the spine (ESP block) is better at managing acute pain from kidney stones compared to standard medications alone. Participants will either receive this injection along with standard care or just the standard treatment.

What are the potential side effects?

Ropivacaine may cause side effects such as low blood pressure, nausea, vomiting, dizziness, numbness around the injection area, and rarely nerve damage. Standard care medications' side effects vary depending on what's used but often include stomach upset and drowsiness.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ before the esp block

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~before the esp block

This trial's timeline: 3 weeks for screening, Varies for treatment, and before the esp block for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Baseline Pain before intervention

Pain score at 10 minutes

Pain score at 20 minutes

+2 more

Secondary study objectives

Need for extra opiates

Awards & Highlights

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

No Placebo-Only Group

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

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Active Control

Group I: ESP Nerve Block for Renal colicActive Control1 Intervention

On top of receiving standard of care, At T8 nerve level, with ultrasound guidance to bathe the nerve

Group II: Standard of careActive Control1 Intervention

Whatever medications the clinician normally treats renal colic with

Do I qualify?Apply below to find out

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 (ESP) Block is a regional anesthesia technique that involves injecting a local anesthetic near the erector spinae muscle to block pain signals at the spinal level, providing targeted pain relief for acute conditions like kidney stones. This method is beneficial as it offers effective pain control without the systemic side effects associated with oral or intravenous medications. Other common treatments include NSAIDs or opioids for pain management, which reduce inflammation or alter pain perception, and alpha-blockers that relax urinary tract muscles to facilitate stone passage. Understanding these mechanisms helps kidney stone patients and their healthcare providers select the most effective and least invasive pain management strategy, improving comfort and outcomes during stone passage.