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

24 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

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 data supports the idea that ESP Block for Kidney Stones is an effective treatment?

The available research shows that the Erector Spinae Plane Block (ESPB) is effective in reducing pain after kidney stone procedures. One study found that ESPB provided better pain relief compared to a placebo in patients who had undergone a procedure to remove kidney stones. Another case series showed that ESPB significantly improved pain in patients with acute kidney stone pain, suggesting it can be a safe and effective treatment option. These findings indicate that ESPB can help manage pain effectively for kidney stone patients. ^{1 2 3 4 5}

What data supports the effectiveness of the treatment Erector Spinae Plane Block for kidney stones?

Research shows that the Erector Spinae Plane Block (ESPB) can effectively reduce pain after surgeries like percutaneous nephrolithotomy (a procedure to remove kidney stones) and has been used successfully for acute pain from kidney stones, suggesting it can be a safe and effective treatment option. ^{1 2 3 4 5}

What safety data exists for ESP Block in treating kidney stones?

The Erector Spinae Plane (ESP) block is considered a safe interfascial plane block with a lower risk of neurovascular and pleural injury compared to epidural or paravertebral blocks. It is noted for its easy sonographic identification and lower complication rate, making it a popular choice in regional anesthesia. Although specific safety data for kidney stones is limited, its application in similar procedures like percutaneous nephrolithotomy (PCNL) and other abdominal surgeries suggests a favorable safety profile. ^{1 2 6 7 8}

Is the ESP Block safe for humans?

The Erector Spinae Plane (ESP) Block is considered safe, with studies showing a lower risk of complications like nerve or lung injury compared to other types of blocks. It is popular due to its ease of use and low complication rate. ^{1 2 6 7 8}

Is the Erector Spinae Plane Block a promising treatment for kidney stones?

Yes, the Erector Spinae Plane Block (ESPB) is a promising treatment for kidney stones. It is shown to provide effective pain relief after kidney stone surgeries and for acute pain from kidney stones. It is simple, safe, and has a lower complication rate compared to other methods, making it a good option for pain management. ^{1 3 5 6 8}

How is the Erector Spinae Plane Block treatment different from other treatments for kidney stones?

The Erector Spinae Plane Block (ESPB) is a novel treatment for kidney stones that involves injecting a local anesthetic near the spine to block pain signals, offering a safer and simpler alternative to more invasive procedures. It is unique because it can be used both as a primary treatment for acute pain from kidney stones and as an adjunct to other pain management strategies, with a lower risk of complications compared to traditional nerve blocks. ^{1 3 5 8 9}

Research Team

Michael Secko, MD

Principal Investigator

StonyBrook University Hospital

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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 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 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]

References

1. India 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. [2022]

2. India pubmed.ncbi.nlm.nih.gov

Fluoroscopic-guided erector spinae plane block for spine surgery. [2022]

3. England 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. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Postoperative Pain Relief Following Lumbar Erector Spinae Plane Block in Patients Undergoing Percutaneous Nephrolithotomy: A Randomized Controlled Trial. [2022]

5. England pubmed.ncbi.nlm.nih.gov

The Erector Spinae Plane Block as Novel Therapy for Renal Colic: A Case Series. [2022]

6. United States 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. [2023]

7. England pubmed.ncbi.nlm.nih.gov

Efficacy of bilateral erector spinae block for post-operative analgesia in liver hydatid surgery. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Relief of refractory renal colic in emergency department: A novel indication for ultrasound guided erector spinae plane block. [2019]

9. Turkey pubmed.ncbi.nlm.nih.gov

The Efficacy of Erector Spinae Plane Block for Patients Undergoing Percutaneous Nephrolithotomy. [2023]