ESPB for Kidney Stone Pain

Overseen By Carmen Colmenero Mahmood

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: University of Michigan

Must not be taking: Strong CYP1A2 inhibitors

Disqualifiers: Pregnancy, Anticoagulation, UTI, 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 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the effectiveness of the Erector Spinae Plane Block (ESPB) in relieving pain from kidney stones. Researchers aim to determine the treatment's effectiveness and potential side effects. Participants will either receive the ESPB treatment or join a control group without it. Suitable candidates have confirmed kidney stones from imaging and have already received strong pain medication in the emergency department. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, giving participants an opportunity to contribute to significant medical advancements.

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.

Is there any evidence suggesting that the Erector Spinae Plane Block (ESPB) is likely to be safe for humans?

Research has shown that the Erector Spinae Plane Block (ESPB) safely manages kidney stone pain. Studies suggest that ESPB may be safer than opioids, commonly used for pain relief, due to a lower risk of nerve or lung complications. Patients using ESPB have generally experienced fewer side effects compared to traditional pain treatments. While this trial will provide more information, current evidence indicates that ESPB is a well-tolerated option for pain relief. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for kidney stone pain?

Most treatments for kidney stone pain rely on medications like NSAIDs or opioids to manage discomfort. But the Erector Spinae Plane Block (ESPB) offers a novel approach by directly targeting nerves in the back to block pain signals. This method could reduce the need for systemic pain medications, minimizing their side effects. Researchers are excited because ESPB could provide quicker and more effective pain relief, potentially transforming how we manage kidney stone pain.

What evidence suggests that the Erector Spinae Plane Block (ESPB) might be an effective treatment for kidney stone pain?

Research shows that the Erector Spinae Plane Block (ESPB), which participants in this trial may receive, holds promise for treating kidney stone pain. Studies have found that ESPB effectively reduces pain by blocking nerve signals in the back. In some cases, it might even outperform traditional painkillers like opioids. Patients who received ESPB reported less pain and better recovery compared to those who did not. Early findings suggest that ESPB could offer a safer option for managing kidney stone pain. ^{1 4 6 7 8}

Who Is on the Research Team?

Chris Fung

Principal Investigator

University of Michigan

Are You a Good Fit for This Trial?

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

Prisoner or incarcerated individual

I have had surgery on my upper back.

Pregnancy or breastfeeding

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Erector Spinae Plane Block (ESPB)
• Ropivacaine

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.

How Is the Trial Designed?

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

Intervention inhibits neurotransmission at the dorsal and ventral rami of the thoracic spinal nerves, providing anesthesia to multiple dermatomal levels

Group II: External control Active Control 1 Intervention

External control patients will be selected from a population of patients meeting the following criteria: 1) adult ED patient with the diagnosis of uncomplicated kidney stones; 2) received at least one dose of parenteral medication while in the ED; 3) presentation to the ED between 7/1/2021 and the study start date. From this population, propensity score matched control patients will be selected at a ratio of 3 controls to 1 ESPB patient. External control population patients are not active patients in this study and analysis of their data will be secondary use of data collected during routine care.

Erector Spinae Plane Block (ESPB) is already approved in United States, European Union for the following indications:

Approved in United States as Erector Spinae Plane Block for:

• Renal colic
• Kidney stone pain

Approved in European Union as Erector Spinae Plane Block for:

• Renal colic
• Kidney stone pain

Who Is Running the Clinical Trial?

University of Michigan

Lead Sponsor

Trials

1,891

Recruited

6,458,000+

Published Research Related to This Trial

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 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]

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]

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]

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]

In a retrospective review of 182 patients, the erector spinae plane block (ESPB) was found to provide effective postoperative pain relief when used as part of a multimodal analgesia plan.

The study noted few complications associated with ESPB, highlighting its safety as a regional anesthesia technique for various thoracoabdominal pain indications.

NCBI (Pubmed)

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. Tulgar, S., Selvi, O., Senturk, O., et al.[2020]

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]

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]

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. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/02/NCT05625802/Prot_SAP_000.pdf

Erector Spinae Plane Block for Uncomplicated Renal Colic ... The ESPB provides analgesia by inhibiting neurotransmission at the dorsal and ventral rami of the thoracic spinal nerves, providing anesthesia ...

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

Efficacy of an erector spinae plane block for renal colic ESPB could offer a safer and more effective alternative to opioids for managing acute renal colic pain, potentially improving patient outcomes ...

4. nature.com nature.com/articles/s41598-024-77075-5

The effect of erector spinae plane block on postoperative ... Our study results indicated that patients who received the ESP block experienced reduced pain levels and had higher QoR-15 scores compared to those who did not ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40199563/

Erector spinae plane block as analgesia for acute renal colic Our findings support the use of ESPB as an effective form of analgesia in renal colic for initial treatment and refractory pain. Further studies ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT05625802

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

7. withpower.com withpower.com/trial/phase-colic-3-2022-218c6

ESP Block for Kidney Stones · Info for Participants The Erector Spinae Plane (ESP) block is considered a safe interfascial plane block with a lower risk of neurovascular and pleural injury compared to ...

8. liebertpub.com liebertpub.com/doi/10.1089/end.2019.0777

Evaluation of the Efficacy of the Erector Spinae Plane Block ... Conclusions: ESPB is a safe technique that provides effective postoperative analgesia in patients undergoing PCNL. ESPB decreases the postoperative VAS score, ...