Erector Spinae Plane Block for Uncomplicated Renal Colic

University of Michigan5 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Renal Colic Kidney Stone

Interventions

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

RopivacaineDRUG

0.5% ropivacaine

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Locations (1)

The University of Michigan

Ann Arbor, Michigan, United States

Outcomes

Primary Outcomes

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

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.

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

Secondary Outcomes

Change in Pain

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.

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

Rate of Admission to Hospital for Kidney Stones

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.

Time frame: Up to 30 days

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

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.

Time frame: Up to 72 hours

Emergency Department Length of Stay

Average length of stay in the emergency department per participant.

Time frame: Up to 30 days

Safety Outcomes and Complications

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.

Data from ClinicalTrials.gov

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