Continuous Erector Spinae Plane Blocks to Treat Pain Following Percutaneous Nephrolithotomy

NCT05121168 | Completed Phase 4 FDA Drug

• 1 other identifier: PCNL and cESPB
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Pain, Acute Postoperative; Renal Stone

Outcome Measures

Primary Outcomes (2)

• 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

  The numeric rating scale is a 0-10 Likert scale measuring pain level with 0 = no pain and 10 = worst imaginable pain scale. To claim that the addition of an ambulatory continuous erector spinae plane block is superior to a single-injection block alone, at least one of the two primary outcomes must be superior while the other at least non-inferior.

  From discharge from the recovery room until the data collection phone call on postoperative day 1, and for the previous 24 hours of the data collection phone call on postoperative day 2.

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

  Total opioid consumption from recovery room discharge until the data collection phone call on postoperative day 2 (measured in oral oxycodone equivalents). To claim that the addition of an ambulatory continuous erector spinae plane block is superior to a single-injection block alone, at least one of the two primary outcomes must be superior while the other at least non-inferior.

  From recovery room discharge until the data collection phone call on postoperative day 2

Secondary Outcomes (18)

• "Worst" pain as measured using the numeric rating scale

  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

• "Worst" pain specifically during urination as measured using the numeric rating scale

  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

• "Average" pain as measured using the numeric rating scale

  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

• "Least" pain as measured using the numeric rating scale

  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

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

  3 time points queried on postoperative days 1-3

Study Arms (2)

Active Treatment

EXPERIMENTAL

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)

Drug: Active bupivacaine 0.25% via an erector spinae plane perineural catheter

Placebo

PLACEBO COMPARATOR

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)

Drug: Placebo normal saline via an erector spinae plane perineural catheter

Interventions

Active bupivacaine 0.25% via an erector spinae plane perineural catheter DRUG

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)

Active Treatment

Placebo normal saline via an erector spinae plane perineural catheter DRUG

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)

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• undergoing unilateral percutaneous nephrolithotomy in the prone position
• analgesic plan includes a single-injection erector spinae plane block
• age 18 years or older

You may not qualify if:

• morbid obesity as defined by a body mass index \> 40 (BMI=weight in kg / \[height in meters\]2)
• renal insufficiency (abnormal preoperative creatinine or estimated glomerular filtration rate)
• chronic opioid use (daily use within the 2 weeks prior to surgery and duration of use \> 4 weeks)
• history of opioid abuse
• any comorbidity which results in moderate or severe functional limitation
• inability to communicate with the investigators or hospital staff
• pregnancy
• bilateral or multi-stage surgical procedures
• incarceration
• known allergy to any study medication
• any contraindication to perineural catheter insertion (e.g., infection at the catheter insertion site)

Sponsors & Collaborators

• University of California, San Diego: lead

Study Sites (2)

UC San Diego

San Diego, California, 92103, United States

Location

University of California, San Diego

San Diego, California, 92103, United States

Location

MeSH Terms

Conditions

Pain, Postoperative; Nephrolithiasis

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urolithiasis; Male Urogenital Diseases

Study Officials

• Brian M Ilfeld, MD, MS

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: All individuals other than the investigational pharmacist who prepares each infusion pump reservoir will be masked to treatment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Anesthesiology, In Residence

Model Details: Randomized, Triple-Masked, Placebo-Controlled, Parallel-Arm Human Subjects Clinical Trial

Study Record Dates

• First Submitted: November 4, 2021
• First Posted: November 16, 2021
• Study Start: March 16, 2022
• Primary Completion: November 6, 2025
• Study Completion: November 8, 2025
• Last Updated: November 25, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)