Erector Spinae Plane Block for Uncomplicated Renal Colic

University of Michigan

Status and phase: Completed; Phase 2

Conditions: Kidney Stone; Renal Colic

Treatments: Procedure: Erector Spinae Plane Block (ESPB); Drug: Ropivacaine

Study type: Interventional

Funder types: Other

Identifiers

NCT05625802

HUM00219913

Details and patient eligibility

About

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

Full description

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.

Enrollment: 5 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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5 participants in 2 patient groups

Erector Spinae Plane Block (ESPB)

Experimental group

Description:

Intervention inhibits neurotransmission at the dorsal and ventral rami of the thoracic spinal nerves, providing anesthesia to multiple dermatomal levels

Treatment:

Drug: Ropivacaine

Procedure: Erector Spinae Plane Block (ESPB)

External control

No Intervention group

Description:

External control patients will be selected from a population of patients meeting the following criteria: 1) adult ED patient with the diagnosis of uncomplicated kidney stones; 2) received at least one dose of parenteral medication while in the ED; 3) presentation to the ED between 7/1/2021 and the study start date. From this population, propensity score matched control patients will be selected at a ratio of 3 controls to 1 ESPB patient. External control population patients are not active patients in this study and analysis of their data will be secondary use of data collected during routine care.