Renal ColicPhase 2NCT05625802
Erector Spinae Plane Block for Uncomplicated Renal Colic
A Phase 2 study testing Erector Spinae Plane Block (ESPB) and Ropivacaine in people with Renal Colic and Kidney Stone, run by University of Michigan at 1 site in United States.
Trial summary
This research study is to determine how well the Erector Spinae Plane Block (ESPB) works for kidney stone pain and any possible side effects. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Colic, Kidney Stone
- What is being tested?
- Erector Spinae Plane Block (ESPB) and Ropivacaine
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Feb 2023to 2 Feb 2024
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
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- 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 locations and contacts
1 site in 1 country.
United States1 site
The University of Michigan
Ann Arbor, Michigan, 48109
About this study
This research study is to determine how well the Erector Spinae Plane Block (ESPB) works for kidney stone pain and any possible side effects.
Read the detailed 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.
- Conditions
- Renal Colic, Kidney Stone
- Being tested
- Erector Spinae Plane Block (ESPB), Ropivacaine
- Keywords
- erector spinae plane block, Emergency Department, ropivacaine
- Medical subject headings
- Renal Colic, Kidney Calculi, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Erector Spinae Plane Block (ESPB)Procedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| Erector Spinae Plane Block (ESPB) | Experimental | Intervention inhibits neurotransmission at the dorsal and ventral rami of the thoracic spinal nerves, providing anesthesia to multiple dermatomal levels Receives: Procedure: Erector Spinae Plane Block (ESPB); Drug: Ropivacaine |
| External control | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: By ED discharge, approximately 12 hours or less
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: Up to 72 hours
Emergency Department Length of Stay
Average length of stay in the emergency department per participant.
Measured: 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.
Measured: Up to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2022
- Study start8 Feb 2023
- Primary completion3 Jan 2024
- Study completion2 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Renal ColicStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Single site two-stage open label phase 2 clinical trial with one treatment arm and one external control arm
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christopher Fung, University of Michigan
- Investigators
- Chris Fung, Study chair, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05625802
- Sponsor's protocol ID
- HUM00219913
- Status last verified
- Oct 2025
- First submitted
- 15 Nov 2022
- Last updated
- 30 Oct 2025
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Erector Spinae Plane Block for Uncomplicated Renal Colic
- ClinicalTrials.gov ID
- NCT05625802
- Acronym / sponsor ID
- HUM00219913
- Conditions
- Renal Colic, Kidney Stone
- Keywords
- erector spinae plane block, Emergency Department, ropivacaine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- 8 Feb 2023 (actual)
- Primary completion
- 3 Jan 2024 (actual)
- Study completion
- 2 Feb 2024 (actual)
- First posted
- 23 Nov 2022 (actual)
- Results
- Posted 30 Oct 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This research study is to determine how well the Erector Spinae Plane Block (ESPB) works for kidney stone pain and any possible side effects.
Detailed 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Single site two-stage open label phase 2 clinical trial with one treatment arm and one external control arm
| Arm | Type | Receives |
|---|---|---|
| Erector Spinae Plane Block (ESPB) | Experimental | Procedure: Erector Spinae Plane Block (ESPB), Drug: RopivacaineIntervention inhibits neurotransmission at the dorsal and ventral rami of the thoracic spinal nerves, providing anesthesia to multiple dermatomal levels |
| External control | No intervention | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Procedure or surgery | Erector Spinae Plane Block (ESPB) |
| Ropivacaine0.5% ropivacaine | Drug | Erector Spinae Plane Block (ESPB) |
Primary outcome
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.
5 secondary outcomes
Change in Pain
Time frame: Baseline, 5 minutes, and 60 minutes following procedure
Rate of Admission to Hospital for Kidney Stones
Time frame: Up to 30 days
Rate of 24-hour and 72-hour Return to the Emergency Department (ED)
Time frame: Up to 72 hours
Emergency Department Length of Stay
Time frame: Up to 30 days
Safety Outcomes and Complications
Time frame: Up to 30 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chris Fung study chair
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Erector Spinae Plane Block (ESPB) and Ropivacaine in people with Renal Colic and Kidney Stone, run by University of Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Oct 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participants Who Received a Second Parenteral Pain Medication in the Emergency Department (ED) (time frame: By ED discharge, approximately 12 hours or less). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2025.