Erector Spinae Plane Block for Uncomplicated Renal Colic

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-08

Study Completion Date

2024-02-02

Brief Summary

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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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Detailed Description

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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.

Conditions

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Renal Colic Kidney Stone

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Single site two-stage open label phase 2 clinical trial with one treatment arm and one external control arm

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Erector Spinae Plane Block (ESPB)

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

Group Type EXPERIMENTAL

Erector Spinae Plane Block (ESPB)

Intervention Type PROCEDURE

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

Ropivacaine

Intervention Type DRUG

0.5% ropivacaine

External control

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Erector Spinae Plane Block (ESPB)

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

Intervention Type PROCEDURE

Ropivacaine

0.5% ropivacaine

Intervention Type DRUG

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No