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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patient received one dose of parenteral pain medication in the emergency department (ED)
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 60 minutes following procedure
Awards & highlights
Study Summary
This trial looks at how well a new spinal injection works to relieve kidney stone pain and if it has any side effects.
Who is the study for?
This trial is for adults with confirmed kidney stones who've had pain medication in the ER. It's not for pregnant or breastfeeding individuals, prisoners, those on blood thinners or with clotting issues, local anesthetic allergies, active COVID-19 infection, UTI treatments, prior thoracic spine surgery, skin infections at the injection site, strong CYP1A2 inhibitor users or G6PD deficiency.Check my eligibility
What is being tested?
The study tests how effective the Erector Spinae Plane Block (ESPB) using Ropivacaine is in managing pain from kidney stones. ESPB is a type of regional anesthesia aimed at reducing discomfort.See study design
What are the potential side effects?
Possible side effects include reactions to Ropivacaine such as numbness and tingling near the injection area, low blood pressure, nausea, vomiting and rarely more serious nerve damage or allergic reactions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I received an injection for pain in the emergency room.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, 60 minutes following procedure
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 60 minutes following procedure
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Proportion of patients receiving a second parenteral pain medication in the Emergency Department (ED)
Secondary outcome measures
Change in pain
Rate of 72-hour return to the Emergency Department (ED)
Rate of admission to hospital
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Erector Spinae Plane Block (ESPB)Experimental Treatment2 Interventions
Group II: External controlActive Control1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Erector Spinae Plane Block (ESPB)
2018
N/A
~70
Ropivacaine
2017
Completed Phase 4
~1960
Find a Location
Who is running the clinical trial?
University of MichiganLead Sponsor
1,797 Previous Clinical Trials
6,377,998 Total Patients Enrolled
2 Trials studying Kidney Stones
1,016 Patients Enrolled for Kidney Stones
Chris FungStudy ChairUniversity of Michigan
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had surgery on my upper back.You are allergic to the numbing medicine used in the area where the procedure will be done.I have G6PD deficiency.I am currently on medication that strongly affects liver enzymes.You have been diagnosed with kidney stones within the last week.I received an injection for pain in the emergency room.I have an infection on the skin where I would get the injection.I am on blood thinners for a clotting disorder.You have tested positive for the coronavirus.I am currently being treated for a urinary tract infection.
Research Study Groups:
This trial has the following groups:- Group 1: Erector Spinae Plane Block (ESPB)
- Group 2: External control
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are any more participants being enrolled for this trial?
"Affirmative. According to the clinicaltrials.gov registry, this medical trial is actively recruiting patients with commencement on November 1st 2022 and a recent edit made on the 22nd of that same month. To complete the study, 60 individuals need to be sourced from a single location."
Answered by AI
How many participants are being granted access to this experiment?
"Affirmative. The information published on clinicaltrials.gov confirms that this medical investigation, which was first posted on November 1st 2022, is actively recruiting participants. Approximately 60 individuals must be sourced from one particular centre."
Answered by AI
Are there any potential risks associated with Erector Spinae Plane Block (ESPB) for medical recipients?
"This Phase 2 trial has yielded evidence that Erector Spinae Plane Block (ESPB) is safe, therefore we have rated it a 2 on our safety scale. There currently isn't any data to support the efficacy of ESPB."
Answered by AI
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