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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up intraoperative (within the operating room)

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 outcome measures

"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

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 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of California, San DiegoLead Sponsor

1,120 Previous Clinical Trials

1,521,585 Total Patients Enrolled

6 Trials studying Postoperative Pain

401 Patients Enrolled for Postoperative Pain

Brian M Ilfeld, MD, MSPrincipal InvestigatorUniversity of California, San Diego

19 Previous Clinical Trials

1,491 Total Patients Enrolled

1 Trials studying Postoperative Pain

7 Patients Enrolled for Postoperative Pain

Media Library

Active bupivacaine 0.25% via an erector spinae plane perineural catheter Clinical Trial Eligibility Overview. Trial Name: NCT05121168 — Phase 4

Postoperative Pain Research Study Groups: Active Treatment, Placebo

Postoperative Pain Clinical Trial 2023: Active bupivacaine 0.25% via an erector spinae plane perineural catheter Highlights & Side Effects. Trial Name: NCT05121168 — Phase 4

Active bupivacaine 0.25% via an erector spinae plane perineural catheter 2023 Treatment Timeline for Medical Study. Trial Name: NCT05121168 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

To what medical condition is Active bupivacaine 0.25% via an erector spinae plane perineural catheter primarily applied?

"Permphigus, acute nonspecific tenosynovitis, and general anesthesia can be treated using Active bupivacaine 0.25% administered through an erector spinae plane perineural catheter."

Answered by AI

Could you provide a tally of the individuals participating in this experiment?

"Affirmative, the clinicaltrials.gov portal indicates that this medical experiment is currently enrolling participants. The trial was first listed on March 16th 2022 and has been recently updated. This study requires 50 individuals to be recruited from 2 different locations."

Answered by AI

Is the use of 0.25% active bupivacaine through a perineural catheter in the erector spinae plane sanctioned by the FDA?

"We rate the safety of Active bupivacaine 0.25% administered via an erector spinae plane perineural catheter to be a 3 due to this being Phase 4 trial, or in other words, approved for use."

Answered by AI

Are there any precedent studies on the efficacy of Active bupivacaine 0.25% administered through an erector spinae plane perineural catheter?

"Presently, 109 clinical trials are currently researching Active bupivacaine 0.25% delivered through an erector spinae plane perineural catheter; 18 of which have reached Phase 3 status. Most studies for this treatment were conducted in Philadelphia, Pennsylvania but other cities also led experiments resulting in 144 different locations where research was done."

Answered by AI

What is the primary purpose of this investigation?

"This trial's primary objective is to measure the mean of "average" pain at rest on postoperative days 1 and 2 across two phone calls. Secondary objectives include calculating the average, worst, and current pain during these calls using a 0-10 Likert scale (wherein 0 = no pain and 10 = worst imaginable pain)."

Answered by AI

Are participants currently being enrolled in this trial?

"Correct. According to information hosted on clinicaltrials.gov, the recruitment for this medical trial began March 16th 2022 and is ongoing. At present, 50 patients need to be recruited from two distinct sites."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Continuous Erector Spinae Plane Blocks to Treat Pain Following Percutaneous Nephrolithotomy

Brian M. Ilfeld, MD, MS 2022. "Continuous Erector Spinae Plane Blocks to Treat Pain Following Percutaneous Nephrolithotomy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05121168.

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