Erector Spinae Plane Block for Postoperative Pain After Kidney Stone Surgery

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

50 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment Erector Spinae Plane Block for Postoperative Pain After Kidney Stone Surgery?

Research shows that the erector spinae plane block, when used with bupivacaine, can effectively reduce pain after kidney stone surgery, as patients reported lower pain scores compared to those who did not receive this treatment. ^{1 2 3 4 5}

Is the Erector Spinae Plane Block generally safe for humans?

The Erector Spinae Plane Block is generally considered safe, but there have been rare cases of unwanted spread of the anesthetic to areas near the spine, which can cause complications. In a study, patients receiving this block for kidney stone surgery showed effective pain relief without significant safety concerns. ^{1 2 4 6 7}

How does the erector spinae plane block treatment differ from other treatments for postoperative pain after kidney stone surgery?

The erector spinae plane block (ESP block) is unique because it is a simple and safe method that involves injecting a local anesthetic near the spine to block pain signals, providing effective pain relief after kidney stone surgery. Unlike traditional intravenous pain medications, the ESP block targets specific nerves, potentially reducing the need for systemic painkillers and their side effects. ^{1 3 4 5 8}

What is the purpose of this trial?

This is a randomized, triple-masked, placebo-controlled parallel-arm human subjects clinical trial investigating the addition of a continuous erector spinae plane nerve block to a single-injection erector spinae plane block to provide postoperative analgesia following percutaneous nephrolithotomy. Participants will all receive a single-injection nerve block and perineural catheter insertion. Following surgery, participants will be randomly allocated to receive either perineural local anesthetic or normal saline until the second day following surgery.

Research Team

Brian Ilfeld, MD

Principal Investigator

University of California, San Diego

Eligibility Criteria

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

I cannot communicate with my doctors or hospital staff.

Known allergy to any study medication

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

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

References

1. 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]

2. England pubmed.ncbi.nlm.nih.gov

Continuous erector spinae plane catheters leading to unwanted neuraxial spread after spinal fusion surgery: a report of two cases from a terminated prospective randomized clinical trial. [2023]

3. 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]

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

Should the Erector Spinae Plane Block Be Applied in the Pain Management of Percutaneous Nephrolithotomy? [2022]

5. New Zealand 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. [2023]

6. England pubmed.ncbi.nlm.nih.gov

Pharmacokinetics of lidocaine after bilateral ESP block. [2021]

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

Analgesia and spread of erector spinae plane block in breast cancer surgeries: a randomized controlled trial. [2022]

8. Spain pubmed.ncbi.nlm.nih.gov

Erector spinae plane block prior to extracorporeal shock wave lithotripsy decreases fluoroscopy time and promise a comfortable procedure for renal stones: A prospective randomized study. [2023]