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Erector Spinae Plane Block for Postoperative Pain After Kidney Stone Surgery

Phase 4

Waitlist Available

Led By Brian M Ilfeld, MD, MS

Research Sponsored by University of California, San Diego

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age 18 years or older

Undergoing unilateral percutaneous nephrolithotomy in the prone position

Must not have

Inability to communicate with the investigators or hospital staff

Any contraindication to perineural catheter insertion (e.g., infection at the catheter insertion site)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up intraoperative (within the operating room)

Awards & highlights

Drug Has Already Been Approved

Pivotal Trial

Summary

This trial is investigating whether adding a continuous erector spinae plane nerve block to a single-injection erector spinae plane block provides better postoperative analgesia following percutaneous nephrolithotomy.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Bupivacaine may cause side effects like numbness beyond the target area, weakness in legs if it spreads to nearby nerves, low blood pressure, nausea or vomiting. Saline has no active drug so typically doesn't have side effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I cannot communicate with my doctors or hospital staff.

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

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I am undergoing or have undergone surgery on both sides of my body or multiple surgeries.

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I have been using opioids daily for more than 4 weeks.

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My kidney function is not normal.

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My BMI is over 40, indicating morbid obesity.

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I have a health condition that severely limits my daily activities.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 time points queried on postoperative days 1-3: from recovery room discharge through the data collection phone call on postoperative day 1; and then the 24 hours preceding a data collection phone call on each of postoperative days 2 and 3

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 time points queried on postoperative days 1-3: from recovery room discharge through the data collection phone call on postoperative day 1; and then the 24 hours preceding a data collection phone call on each of postoperative days 2 and 3

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 time points queried on postoperative days 1-3: from recovery room discharge through the data collection phone call on postoperative day 1; and then the 24 hours preceding a data collection phone call on each of postoperative days 2 and 3 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

The mean of the "average" pain at rest on postoperative days 1 and 2 as measured using the numeric rating scale, collected on postoperative days 1 and 2

Total opioid consumption from recovery room discharge until the data collection phone call on postoperative day 2 (measured in oral oxycodone equivalents)

Secondary study objectives

"Average" pain as measured using the numeric rating scale

"Current" pain at the time of the data collection phone call as measured using the numeric rating scale

"Least" pain as measured using the numeric rating scale

+15 more

Awards & Highlights

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Active TreatmentExperimental Treatment1 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: PlaceboPlacebo Group1 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)

0 / 10Eligibility criteria met