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Completed

NCT Number: NCT05625802

Erector Spinae Plane Block for Uncomplicated Renal Colic

This research study is to determine how well the Erector Spinae Plane Block (ESPB) works for kidney stone pain and any possible side effects.

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Key information

Conditions

Renal Colic Calculi Disease Attributes Emergencies Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Calculi Kidney Diseases Kidney Stone Male Urogenital Diseases Nephrolithiasis Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Signs and Symptoms Urinary Calculi Urogenital Diseases Urolithiasis Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

The University of Michigan

Ann Arbor, Michigan, 48109, United States

About this study

When this trial was initially started, the intent was to compare the Erector Spinae Plane Block (ESPB) arm to data from electronic health records (EHR) of patients who had not received the ESPB. The EHR data was never obtained, so no comparison was conducted.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Imaging confirmation of urolithiasis on the index encounter or prior encounter within 7 days
  • Patient received one dose of parenteral pain medication in the emergency department (ED)

Exclusion criteria

  • Pregnancy or breastfeeding
  • Prisoner or incarcerated individual
  • Therapeutic anticoagulation or coagulopathy.
  • Active treatment for urinary tract infection (either acute infection or chronic therapy)
  • Prior spinal surgery in the thoracic region
  • Allergy to local anesthetic or prior local anesthetic
  • Soft tissue infection overlying the injection site
  • Positive for coronavirus
  • Inability to communicate verbally or read/write in English
  • Currently taking strong CYP1A2 inhibitor (fluvoxamine, amiodarone, fluoroquinolones, etc.)
  • Glucose-6-phosphate dehydrogenase deficiency (G6PD)

Treatment and study plan

Erector spinae plane block (ESPB)

Procedure

Up to 30 Cubic Centimeter (cc) of 0.5% ropivacaine administered by local injection into the erector spinae plane under ultrasound guidance

Ropivacaine

Drug

0.5% ropivacaine

Primary outcomes

  1. Participants Who Received a Second Parenteral Pain Medication in the Emergency Department (ED)

    Time frame: By ED discharge, approximately 12 hours or less

    Results reflect the number of participants who received a second parenteral pain medication after receiving one already. Data for this outcome was collected via electronic health record query.

Secondary outcomes

  1. Change in Pain

    Time frame: Baseline, 5 minutes, and 60 minutes following procedure

    Pain ranked on a visual analog scale of 1-10, where 10 indicated the most pain and 1 indicated no pain. Change was defined as the last pain score minus first pain score.

  2. Rate of Admission to Hospital for Kidney Stones

    Time frame: Up to 30 days

    Results reflect participants who were admitted to the hospital for kidney stones at or prior to day 7 and at or prior to day 30 following administration of the intervention. Data for this outcome was collected via electronic health record query.

  3. Rate of 24-hour and 72-hour Return to the Emergency Department (ED)

    Time frame: Up to 72 hours

    Results reflect participants who returned to the ED for kidney stone-related issues at 24 hours and 72 hours following administration of the intervention. Data for this outcome was collected via electronic health record query.

  4. Emergency Department Length of Stay

    Time frame: Up to 30 days

    Average length of stay in the emergency department per participant.

  5. Safety Outcomes and Complications

    Time frame: Up to 30 days

    Results reflect the number of participants who were still in the trial by day 30 and had experienced any of the pre-defined safety events.

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Nov 23, 2022
Registry last updated
Oct 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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