ESP Block for Kidney Stones

Overseen By Michael Secko, MD

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Stony Brook University

Disqualifiers: Pregnancy, Cardiac dysfunction, Liver dysfunction, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 1 hour

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method to alleviate severe pain from kidney stones. Researchers aim to determine if the erector spinae plane (ESP) block, which numbs specific nerves, is more effective than standard pain treatments. Participants will receive either the ESP block with their usual care or just the usual care. Suitable candidates for this trial are those who have experienced sudden and severe flank pain from kidney stones while visiting the emergency department. As a Phase 4 trial, this research seeks to understand how the already FDA-approved and effective treatment benefits a broader range of patients.

Do I need to stop my current medications to join the trial?

The trial protocol does not specify whether you need to stop taking your current medications.

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 is the safety track record for the Erector Spinae Plane Block and Ropivacaine?

Research shows that the erector spinae plane block (ESPB) safely manages pain. Studies have found that ESPB can reduce the need for opioids, which are strong painkillers with many side effects. This suggests that ESPB could offer a safer option for pain relief.

Previous studies have not reported major side effects from ESPB. Compared to placebos (fake treatments used for comparison), ESPB has been found safe and effective, suggesting it might have fewer risks than other pain treatments. The procedure uses ultrasound to guide the injection, ensuring accuracy and safety.

So far, no serious concerns have arisen about using ESPB for pain, such as kidney stone pain. Patients seem to tolerate it well. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about the Erector Spinae Plane (ESP) Block for kidney stones because it utilizes a unique method of pain management. Unlike standard treatments for renal colic, which often rely on oral or intravenous medications like NSAIDs or opioids, the ESP Block involves a targeted nerve block at the T8 level. This precision approach, guided by ultrasound, aims to directly relieve pain by "bathing" the affected nerves, potentially offering faster and more effective relief without the systemic side effects associated with traditional medications.

What evidence suggests that the Erector Spinae Plane Block is effective for acute renal colic pain?

Research has shown that the erector spinae plane block (ESPB), which participants in this trial may receive, can effectively reduce sudden pain from kidney stones. Studies have found that ESPB decreases the need for pain medication during and after medical procedures. Experts consider it a safe and effective option for relieving kidney stone pain. While some results are statistically significant, some experts still seek more evidence about its effects. Overall, ESPB appears promising for managing kidney stone pain. ^{1 3 4 6 7}

Who Is on the Research Team?

Michael Secko, MD

Principal Investigator

StonyBrook University Hospital

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

ASA Level I and II

I am experiencing severe side pain, possibly from kidney stones.

Exclusion Criteria

Allergy to local anesthesia (lidocaine/Ropivacaine)

I have a bleeding disorder.

I have had surgery on my spine.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

Treatment

Participants receive either the ESP Nerve Block or standard of care for renal colic pain

1 hour

1 visit (in-person)

Follow-up

Participants are monitored for pain relief and need for additional opiates until discharge or urology intervention

Until discharge

What Are the Treatments Tested in This Trial?

Interventions

• Erector Spinae Plane Block
• Ropivacaine

Trial Overview 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.

How Is the Trial Designed?

Group I: ESP Nerve Block for Renal colic Active Control 1 Intervention

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

Group II: Standard of care Active Control 1 Intervention

Whatever medications the clinician normally treats renal colic with

Who Is Running the Clinical Trial?

Stony Brook University

Lead Sponsor

Trials

225

Recruited

41,700+

Published Research Related to This Trial

The Erector Spinae Plane (ESP) block is gaining popularity due to its easy identification using ultrasound and a lower complication rate compared to other regional anesthesia techniques.

This study introduces a novel use of the ESP block for treating renal colic in the emergency department, suggesting its potential for broader applications beyond traditional anesthetic practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Relief of refractory renal colic in emergency department: A novel indication for ultrasound guided erector spinae plane block. Aydin, ME., Ahiskalioglu, A., Tekin, E., et al.[2019]

The bilateral erector spinae plane (ESP) block was successfully used for post-operative analgesia in a 56-year-old patient undergoing liver hydatid surgery, demonstrating its safety and effectiveness with minimal pain reported post-surgery.

The patient experienced a sensory block from T4 to T10 and required only one dose of paracetamol for pain relief after 12 hours, indicating that the ESP block can provide significant analgesia compared to traditional methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of bilateral erector spinae block for post-operative analgesia in liver hydatid surgery. Daghmouri, MA., Mesbahi, M., Akremi, S., et al.[2022]

The Erector Spinae Plane (ESP) block provided significantly longer pain relief after percutaneous nephrolithotomy (PCNL) compared to conventional peritubular local anesthetic infiltration, with patients in the ESP group waiting an average of 16.21 hours for their first rescue analgesic compared to 6.93 hours in the peritubular group.

Patients receiving the ESP block reported lower pain scores and required fewer rescue analgesics in the first 24 hours post-surgery, indicating that the ESP block is a highly effective and safe method for managing postoperative pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of the efficacy of erector spinae plane block and peritubal infiltration of levobupivacaine for postoperative analgesia following percutaneous nephrolithotomy. Lomate, P., Jadhav, VR., Yadav, A.[2022]

In a clinical trial involving nephrectomy patients, those who received an erector spinae plane (ESP) block reported significantly lower pain scores in the first 24 hours post-surgery compared to those who did not receive the block.

The ESP block group also used fewer opioids and had better recovery quality, indicating that this technique may enhance postoperative pain management and improve patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of ultrasound-guided erector spinae plane block on post-surgical pain in patients undergoing nephrectomy: a single-center, randomized, double-blind, controlled trial. Şahin, A., Baran, O.[2022]

In a study of 34 patients undergoing Percutaneous Nephrolithotomy (PCNL), lumbar Erector Spinae Plane Block (ESPB) with Bupivacaine significantly reduced the need for rescue opioid analgesics, with a 24-hour requirement of 53.5 mg compared to 121.2 mg in the placebo group.

Patients receiving Bupivacaine also experienced a longer time before needing additional pain relief (14.1 hours vs. 6.0 hours) and lower pain scores at 12 hours post-surgery, indicating that ESPB is an effective method for managing postoperative pain without complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Postoperative Pain Relief Following Lumbar Erector Spinae Plane Block in Patients Undergoing Percutaneous Nephrolithotomy: A Randomized Controlled Trial. Sarkar, S., Jena, SS., Nayak, P., et al.[2022]

A case series of 10 patients demonstrated that the erector spinae plane block (ESPB) can effectively reduce acute pain from renal colic, indicating its potential as a treatment option in emergency settings.

The ESPB was performed using an in-plane needle approach with ultrasound guidance, and patients reported significant pain relief, suggesting it is a safe and effective method for managing this type of pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Erector Spinae Plane Block as Novel Therapy for Renal Colic: A Case Series. Noble, M., Cann, J., Feyzeau, K., et al.[2022]

The erector spinae plane block (ESPB) significantly reduces postoperative pain and analgesic consumption in patients undergoing percutaneous nephrolithotomy (PCNL), based on a meta-analysis of 8 studies involving 456 patients.

ESPB not only improves pain management but also prolongs the time until the first request for analgesia, all without significant postoperative complications, making it a safe and effective anesthesia method for this procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The safety and efficacy of ultrasound-guided erector spinae plane block in postoperative analgesic of PCNL: A systematic review and meta-analysis. Liu, J., Fang, S., Wang, Y., et al.[2023]

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]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39424347/

Efficacy of an erector spinae plane block for renal colic This systematic review summarises the current body of evidence on the efficacy and safety of ESPB for renal colic in the ED.

2. pure.rug.nl pure.rug.nl/ws/portalfiles/portal/1347625571/317.full.pdf

Efficacy of an erector spinae plane block for renal colic Conclusions Although statistically significant, there is a low certainty regarding the positive effect of ESPB on pain reduction for renal colic ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10339747/

The Efficacy of Erector Spinae Plane Block for Patients ... Our results showed that erector spinae plane block (ESPB) reduces intraoperative and postoperative opioid consumption and postoperative pain ...

4. authorea.com authorea.com/users/350483/articles/475311-erector-spinae-plane-block-vs-nonsteroidal-anti-inflammatory-drugs-for-severe-renal-colic-pain-a-pilot-clinical-feasibility-study

Erector spinae plane block vs. Nonsteroidal anti- ... Conclusions: ESP block can be an alternative, efficient, and safe method for the relief of acute renal colic pain. Peer review status:Published. 11 Aug 2020 ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT06131151

Comparison Between External Oblique Intercostal Block ... The aim of this study is to compare the post-operative analgesic effect of USG unilateral External oblique intercostal (EOI) block with Erector spinae plane ...

6. mdpi.com mdpi.com/2079-7737/12/8/1073

Erector Spinae Plane Block and Chronic Pain Undoubtedly, the ESP block has proven to be a safe and effective approach when compared to placebos or no intervention. However, there is still much to explore ...

7. journals.lww.com journals.lww.com/joacp/fulltext/2025/01000/efficacy_of_erector_spinae_plane_block_for.8.aspx

Efficacy of erector spinae plane block for postoperative... Pain scores were significantly lower in the ESPB group as compared to the control group except at the 12 th postoperative hour. There were significantly better ...