Erector Spinae Plane Block for Postoperative Pain After Kidney Stone Surgery

No longer recruiting at 1 trial location

Overseen By John Finneran, MD

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: University of California, San Diego

Must not be taking: Opioids

Disqualifiers: Morbid obesity, Renal insufficiency, Pregnancy, others

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

Compensation: Varies

Number of Visits: 2

Duration: 2 days

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to manage pain after kidney stone surgery using a type of nerve block. The researchers aim to determine if adding a continuous nerve block with bupivacaine (a local anesthetic) reduces pain more effectively than a single-injection block alone. Participants will receive either bupivacaine or a placebo (saline) through a catheter. This trial may suit individuals undergoing a specific kidney stone surgery called percutaneous nephrolithotomy, who are scheduled to receive a single-injection nerve block for pain relief. As a Phase 4 trial, the treatment is already FDA-approved and proven effective, and it seeks to understand how it benefits more patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you are using opioids regularly, you may not be eligible to participate.

What is the safety track record for these treatments?

Research shows that the erector spinae plane (ESP) block with bupivacaine 0.25% is generally safe. Studies have found this block effective for pain relief after surgeries like kidney stone removal. One study confirmed that the ESP block safely and effectively manages pain after such surgery. Another study highlighted the frequent use of bupivacaine for this block and advised staying within safe dosage limits to avoid side effects.

Bupivacaine is a well-known local anesthetic and has been used safely in many similar procedures. However, following the recommended dose is crucial to minimize risks. Overall, evidence suggests that the treatment is well-tolerated in humans when used correctly. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about the Erector Spinae Plane Block technique for postoperative pain after kidney stone surgery because it offers a targeted method of pain relief. Unlike typical systemic pain management options like opioids or oral analgesics, this approach uses bupivacaine 0.25%, an anesthetic delivered directly through a catheter to the erector spinae plane, which can provide localized pain control with potentially fewer side effects. This delivery method allows for continuous, programmable pain relief, potentially reducing the need for additional medication and offering more consistent pain management. Additionally, the placebo comparison using normal saline helps to clearly assess the effectiveness of this targeted approach.

What evidence suggests that the continuous erector spinae plane block is effective for postoperative pain after kidney stone surgery?

Research has shown that the erector spinae plane (ESP) block effectively reduces pain after kidney stone surgery. In this trial, participants in the active treatment arm will receive an ESP block with bupivacaine, a local anesthetic. Studies have found that this significantly lowers pain levels from 30 minutes to 24 hours post-surgery. Other findings indicate that ESP blocks can decrease the need for pain medications like morphine after the procedure. Specifically, bupivacaine helps manage pain when used in the surgical area. This treatment provides longer-lasting pain relief after surgery, making recovery more comfortable. ^{1 3 6 7 8}

Who Is on the Research Team?

Brian Ilfeld, MD

Principal Investigator

University of California, San Diego

Are You a Good Fit for This Trial?

This trial is for adults over 18 who are having a kidney stone removal surgery called unilateral percutaneous nephrolithotomy and will receive an erector spinae plane block for pain. It's not for pregnant individuals, those with allergies to the drugs used, kidney problems, chronic opioid use or abuse, severe health issues limiting function, extreme obesity, or if they can't communicate with staff.

Inclusion Criteria

I am having a kidney stone removal surgery on one side, lying face down.

My pain management plan includes a specific type of single-injection nerve block.

Exclusion Criteria

Known allergy to any study medication

I cannot communicate with my doctors or hospital staff.

I don't have infections where a catheter would be inserted.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Preoperative Procedures

Baseline anthropometric information is recorded, and a peripheral IV catheter is inserted. Participants receive midazolam and fentanyl for comfort.

1 day

1 visit (in-person)

Treatment

Participants undergo percutaneous nephrolithotomy and receive a single-injection nerve block and perineural catheter insertion. Randomized to receive either bupivacaine or saline.

2 days

Inpatient stay

Postoperative Monitoring

Participants are monitored for pain management and catheter function. Perineural catheters are removed upon study infusate reservoir exhaustion.

2-3 days

Follow-up

Participants are monitored for safety and effectiveness after treatment, including pain and opioid consumption assessments.

3 days

Phone calls on postoperative days 1-3

What Are the Treatments Tested in This Trial?

Interventions

• Bupivacaine 0.25%
• Continuous Erector Spinae Plane Blocks
• Normal Saline

Trial Overview The study tests whether adding a continuous nerve block to a single-injection one after kidney stone surgery reduces pain. Participants get either real local anesthetic bupivacaine or placebo saline through a catheter until the second day post-surgery.

How Is the Trial Designed?

Group I: Active Treatment Experimental Treatment 1 Intervention

Administration of bupivacaine 0.25% through a perineural catheter inserted into the erector spinae plane (programmed intermittent bolus of 21 mL every 4 hours and no patient-controlled bolus)

Group II: Placebo Placebo Group 1 Intervention

Administration of normal saline through a perineural catheter inserted into the erector spinae plane (programmed intermittent bolus of 21 mL every 4 hours and no patient-controlled bolus)

Who Is Running the Clinical Trial?

University of California, San Diego

Lead Sponsor

Trials

1,215

Recruited

1,593,000+

Published Research Related to This Trial

Adding 20 mg of nalbuphine to ropivacaine in an erector spinae plane block significantly prolongs the time to first opioid demand after percutaneous nephrolithotomy, with a median time of 8.70 hours compared to 2.90 hours for ropivacaine alone.

The combination of nalbuphine and ropivacaine also reduces postoperative morphine consumption, indicating enhanced analgesic efficacy without compromising safety, as VAS pain scores remained comparable across all groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Analgesic Efficacy of Nalbuphine as an Adjuvant to Ropivacaine in Erector Spinae Plane Block for Percutaneous Nephrolithotomy: A Randomized, Double-Blinded, Clinical Trial. Sun, M., Wu, Z., Wang, R., et al.[2023]

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 case series of 10 patients undergoing bilateral erector spinae plane (ESP) block for lumbar spine surgery, lidocaine showed a rapid absorption with peak concentrations (Cmax) ranging from 1.2 to 3.8 mg/L, which remained below toxicity limits.

The pharmacokinetics of lidocaine after ESP block indicated high bioavailability (average AUC0-3 of 76%) and a slightly prolonged elimination half-life in older patients, suggesting that age may influence drug metabolism.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacokinetics of lidocaine after bilateral ESP block. De Cassai, A., Bonanno, C., Padrini, R., et al.[2021]

In a study of 60 patients undergoing percutaneous nephrolithotomy, the erector spinae plane block (ESPB) significantly reduced postoperative pain levels compared to the control group, as measured by the visual analog scale (VAS) at multiple time points (0, 6, and 24 hours).

Patients receiving the ESPB also experienced better respiratory outcomes, with a lower incidence of agitation and improved peak expiratory flow rates (PEFR) compared to those who only received intravenous analgesia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Should the Erector Spinae Plane Block Be Applied in the Pain Management of Percutaneous Nephrolithotomy? Unal, S., Baskan, S., Guven Aytac, B., et al.[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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8944355/

Comparison of the efficacy of erector spinae plane block ... Conclusion: ESP block is a very effective and safe technique to provide prolonged duration of postoperative analgesia following PCNL. Peritubal ...

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

The Efficacy of Erector Spinae Plane Block for Patients ... We detected that ESPB reduced postoperative pain in PCNL patients. GBlock described lower pain scores from the 30th minute to 24th hour ...

3. journals.lww.com journals.lww.com/njcp/fulltext/2022/25020/effectiveness_of_erector_spinae_plane_block_in.11.aspx

Effectiveness of erector spinae plane block in patients... In this study, we observed that USG-guided ESPB significantly reduced the consumption of morphine in the postoperative 24 h for PCNL operations and increased ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S009042951300589X

The Efficacy of Bupivacaine Infiltration on the Nephrostomy ... The results of the present study demonstrate that bupivacaine infiltration into the nephrostomy tract reduces the pain related to the nephrostomy tube after ...

5. journals.lww.com journals.lww.com/joacp/fulltext/2011/27040/the_analgesic_efficacy_of_peritubal_infiltration.9.aspx

The analgesic efficacy of peritubal infiltration of 0.25%... Conclusion: Peritubal infiltration of 0.25% bupivacaine is efficient in alleviating postoperative pain after PCNL. Introduction. Percutaneous nephrolithotomy ( ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8036507/

Erector Spinae Plane Block for Perioperative Analgesia ... Erector spinae plane block is an effective pain treatment after percutaneous nephrolithotomy but only for a very short postoperative period.

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S009042952100978X

Postoperative Pain Relief Following Lumbar Erector ... In conclusion, ipsilateral Erector Spinae Plane Block with 20 ml Inj. Bupivacaine 0.25% at the L1 vertebral level, proved to be a safe and effective novel ...

8. 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 ...