ESPB for Kidney Stone Pain

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: University of Michigan

Must not be taking: Strong CYP1A2 inhibitors

Disqualifiers: Pregnancy, Anticoagulation, UTI, others

No Placebo Group

Prior Safety Data

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

This research study is to determine how well the Erector Spinae Plane Block (ESPB) works for kidney stone pain and any possible side effects.

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

The trial protocol does not specify if you need to stop taking your current medications, but you cannot participate if you are currently taking strong CYP1A2 inhibitors like fluvoxamine, amiodarone, or fluoroquinolones.

What data supports the idea that ESPB for Kidney Stone Pain is an effective treatment?

The available research shows that ESPB is effective in managing pain after surgeries, including those related to the kidneys. For example, one study found that ESPB helped control pain after kidney surgery, specifically in patients who had a nephrectomy, which is the removal of a kidney. Another study compared ESPB to patient-controlled pain relief methods and found that ESPB was effective in reducing pain after kidney surgery. These studies suggest that ESPB can be a good option for managing pain after kidney-related procedures. ^{1 2 3 4 5}

What safety data exists for ESPB in treating kidney stone pain?

The safety of the erector spinae plane block (ESPB) has been evaluated in various studies, primarily focusing on its efficacy and safety for postoperative analgesia in surgeries like percutaneous nephrolithotomy (PCNL) and open nephrectomy. These studies suggest that ESPB is a simple and safe interfascial plane block that provides effective postoperative pain relief. However, specific safety data for ESPB in the context of kidney stone pain is limited, and more evidence is needed to fully establish its safety profile in this specific application. ^{1 2 3 6 7}

Is the treatment Erector Spinae Plane Block (ESPB) promising for kidney stone pain?

The provided research articles do not contain information about the Erector Spinae Plane Block (ESPB) or its effectiveness for kidney stone pain. Therefore, we cannot determine if ESPB is a promising treatment for this condition based on the given data. ^{8 9 10 11 12}

Research Team

Chris Fung

Principal Investigator

University of Michigan

Eligibility Criteria

This trial is for adults with confirmed kidney stones who've had pain medication in the ER. It's not for pregnant or breastfeeding individuals, prisoners, those on blood thinners or with clotting issues, local anesthetic allergies, active COVID-19 infection, UTI treatments, prior thoracic spine surgery, skin infections at the injection site, strong CYP1A2 inhibitor users or G6PD deficiency.

Inclusion Criteria

You have been diagnosed with kidney stones within the last week.

I received an injection for pain in the emergency room.

Exclusion Criteria

I have had surgery on my upper back.

Prisoner or incarcerated individual

Pregnancy or breastfeeding

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive the Erector Spinae Plane Block (ESPB) for kidney stone pain

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Erector Spinae Plane Block (ESPB) (Procedure)
• Ropivacaine (Local Anesthetic)

Trial Overview The study tests how effective the Erector Spinae Plane Block (ESPB) using Ropivacaine is in managing pain from kidney stones. ESPB is a type of regional anesthesia aimed at reducing discomfort.

Participant Groups

Group I: Erector Spinae Plane Block (ESPB) Experimental Treatment 2 Interventions

Group II: External control Active Control 1 Intervention

Who Is Running the Clinical Trial?

University of Michigan

Lead Sponsor

Trials

1,891

Recruited

6,458,000+

Marschall S. Runge

University of Michigan

Chief Executive Officer since 2015

MD, PhD

Karen McConnell

University of Michigan

Chief Medical Officer since 2020

MD

Findings from Research

Ultrasound-guided erector spinae plane block (ESPB) provided significantly better postoperative pain relief compared to traditional subcutaneous infiltration of bupivacaine, with lower numeric rating scale (NRS) scores in patients undergoing percutaneous nephrolithotomy (PCNL).

Patients receiving ESPB experienced a longer duration before needing additional analgesia (12 hours) and required less total tramadol for pain management over 24 hours, indicating an opioid-sparing effect.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of erector spinae plane block and local anaesthetic infiltration of the incision site for postoperative analgesia in percutaneous nephrolithotomy - A randomised parallel-group study. Ramachandran, S., Ramaraj, KP., Velayudhan, S., et al.[2022]

The erector spinae plane block (ESPB) significantly reduced the need for opioids post-surgery, with lower total morphine consumption in the first 48 hours compared to intravenous patient-controlled analgesia (PCA).

Patients receiving ESPB experienced longer time to first analgesic request and lower pain scores at rest and during movement, indicating more effective pain management after open nephrectomy for renal malignancies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ultrasound Guided Continuous Erector Spinae Plane Block versus Patient Controlled Analgesia in Open Nephrectomy for Renal Malignancies: A Randomized Controlled Study. Abdelgalil, AS., Ahmed, AM., Gamal, RM., et al.[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]

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) 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]

In a study of 193 patients with acute kidney injury (AKI) due to snake bites, 26% developed chronic kidney disease (CKD) during long-term follow-up, highlighting the serious long-term impact of snake envenomation on kidney health.

Risk factors for developing CKD included older age, diabetes, severe AKI, and inadequate administration of anti-snake venom, indicating that timely and effective treatment is crucial for preventing long-term kidney damage.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Chronic Kidney Disease after Snake Envenomation Induced Acute Kidney Injury. Ariga, K., Dutta, TK., Haridasan, S., et al.[2021]

Two patients who suffered from sea-snake bites experienced myoglobinuria, renal failure, and muscular paralysis, which were linked to renal tubular necrosis and myonecrosis as shown by biopsy.

Treatment with haemodialysis effectively removed potassium and uraemic factors, leading to a rapid improvement in muscular symptoms, suggesting that haemodialysis could be a valuable alternative to traditional antivenom for treating sea-snake bite poisoning.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Haemodialysis in poisoning by sea-snake venom. Sitprija, V., Sribhibhadh, R., Benyajati, C.[2022]

In a 15-year study of 181 patients with acute kidney injury (AKI) caused by venomous animals, snakebites (77.9%) and wasp stings (19.9%) were identified as the primary causes, highlighting the significant risk these encounters pose.

The study found that 82.3% of patients required dialysis, and the overall mortality rate was 14.9%, with higher laboratory abnormalities and complications associated with those who did not survive, indicating the severe nature of AKI from venomous animal bites.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Epidemiology and outcome of acute kidney injury due to venomous animals from a subtropical region of India. Vikrant, S., Jaryal, A., Gupta, D., et al.[2020]

In a study involving 20 pigs, pressure immobilization applied after Crotalus atrox venom injection significantly increased survival time, with a median of 191 minutes compared to 155 minutes in the control group.

The pressure immobilization also resulted in higher intracompartmental pressures and less swelling in the affected leg, indicating it may help manage the effects of venom envenomation more effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pressure immobilization delays mortality and increases intracompartmental pressure after artificial intramuscular rattlesnake envenomation in a porcine model. Bush, SP., Green, SM., Laack, TA., et al.[2019]

In a study of 127 patients with Bothrops atrox snakebite envenomings in the Brazilian Amazon, 38.6% developed acute kidney injury (AKI), with younger (0-10 years) and older (≥60 years) age groups being at higher risk.

Key predictors of AKI included nausea and elevated blood urea levels, while moderate to severe edema in the affected limb was associated with a lower risk of AKI, indicating that both clinical symptoms and venom levels play a significant role in the severity of kidney damage.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The severity of acute kidney injury correlates with plasma venom levels in Bothrops atrox envenomings. Brasileiro-Martins, LM., Nascimento, TP., Silva-Neto, AV., et al.[2022]

References

1. India pubmed.ncbi.nlm.nih.gov

Comparison of erector spinae plane block and local anaesthetic infiltration of the incision site for postoperative analgesia in percutaneous nephrolithotomy - A randomised parallel-group study. [2022]

2. New Zealand pubmed.ncbi.nlm.nih.gov

Ultrasound Guided Continuous Erector Spinae Plane Block versus Patient Controlled Analgesia in Open Nephrectomy for Renal Malignancies: A Randomized Controlled Study. [2022]

3. India pubmed.ncbi.nlm.nih.gov

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

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

Ultrasound-guided Erector Spinae Plane Block: Indications, Complications, and Effects on Acute and Chronic Pain Based on a Single-center Experience. [2020]

5. 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]

6. 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]

7. 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]

8. Saudi Arabia pubmed.ncbi.nlm.nih.gov

Chronic Kidney Disease after Snake Envenomation Induced Acute Kidney Injury. [2021]

9. England pubmed.ncbi.nlm.nih.gov

Haemodialysis in poisoning by sea-snake venom. [2022]

10. England pubmed.ncbi.nlm.nih.gov

Epidemiology and outcome of acute kidney injury due to venomous animals from a subtropical region of India. [2020]

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

Pressure immobilization delays mortality and increases intracompartmental pressure after artificial intramuscular rattlesnake envenomation in a porcine model. [2019]

12. England pubmed.ncbi.nlm.nih.gov

The severity of acute kidney injury correlates with plasma venom levels in Bothrops atrox envenomings. [2022]