Renal ColicPhase 4NCT05323175
Erector Spinae Plane (ESP) Block for Renal Colic
A Phase 4 study testing Ropivacaine injection in people with Renal Colic, run by Stony Brook University at 1 site in United States.
Trial summary
Comparing standard of care to erector spinae plane block for acute renal colic pain. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Renal Colic
- What is being tested?
- Ropivacaine injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Apr 2022to 9 Jan 2026
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 to 65 years old
- ASA Level I and II
- flank pain concerning for renal colic in ED
Who cannot join
- pregnant women
- subjects unable to appreciate ESP block landmarks under ultrasound
- skin infection over needle site insertion
- Allergy to local anesthesia (lidocaine/Ropivacaine)
- bleeding disorders
- serious cardiac, lung, liver or kidney dysfunction
Show all 12Show fewer
- history of spine surgery
- history of spinal infection
- history of epidural injection within 6 months
- acute exacerbation of serious mental disease
- unable to consent
- unable to communicate pain level
Trial locations and contacts
1 site in 1 country.
United States1 site
StonyBrook University Hospital
Stony Brook, New York, 11794
About this study
Official title: Can Erector Spinae Plane (ESP) Block Better Relieve Acute Renal Colic Pain Than Standard of Care
Comparing standard of care to erector spinae plane block for acute renal colic pain.
Read the detailed description
Will compare at times 0, 10 minute, 20 minute, 40 minute and 60 minutes after local nerve block given.
- Conditions
- Renal Colic
- Being tested
- Ropivacaine injection, Standard of care medications
- Keywords
- Erector spinae plane block
- Medical subject headings
- Renal Colic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ropivacaine injectionDrug
Local anesthesia injected under ultrasound guidance
Standard of care medicationsOther
Whatever the ED clinicians normally give for renal colic pain
| Study group | Role | What they receive |
|---|---|---|
| ESP Nerve Block for Renal colic | Active comparator | On top of receiving standard of care, At T8 nerve level, with ultrasound guidance to bathe the nerve Receives: Drug: Ropivacaine injection |
| Standard of care | Active comparator | Whatever medications the clinician normally treats renal colic with Receives: Other: Standard of care medications |
What is being measured
The primary outcome is the main question the study is designed to answer.
Baseline Pain before intervention
Using the Visual Analog Scale for Pain Assessment Tool with 0 meaning "No pain" and 10 meaning "Unbearable Pain"
Measured: Before the ESP Block
Pain score at 10 minutes
Using the Visual Analog Scale for Pain Assessment Tool with 0 meaning "No pain" and 10 meaning "Unbearable Pain"
Measured: 10 minutes after the ESP Block
Pain score at 20 minutes
Using the Visual Analog Scale for Pain Assessment Tool with 0 meaning "No pain" and 10 meaning "Unbearable Pain"
Measured: 20 minutes after ESP Block
Pain score at 40 minutes
Using the Visual Analog Scale for Pain Assessment Tool with 0 meaning "No pain" and 10 meaning "Unbearable Pain
Measured: 40 minutes after ESP Block
Pain score at 60 minutes
Using the Visual Analog Scale for Pain Assessment Tool with 0 meaning "No pain" and 10 meaning "Unbearable Pain
Measured: 60 minutes after ESP Block
Secondary outcomes (1)
Need for extra opiates
Record how much opioids patients receives starting after the ESP Block for both the "standard of care" patients and the ESP Block group
Measured: Starting from time 0 after the ESP Block intervention completed till discharge or urology intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2022
- Study start25 Apr 2022
- Primary completion9 Jan 2026
- Study completion9 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Renal ColicStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Standard of care group + sham normal saline ESP block vs Standard of care + Ropivacaine ESP nerve Block group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stony Brook University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Secko, MD, Stony Brook University
- Investigators
- Michael Secko, MD, Principal investigator, StonyBrook University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05323175
- Sponsor's protocol ID
- IRB2021-00518
- Status last verified
- Jan 2025
- First submitted
- 8 Oct 2021
- Last updated
- 3 Jun 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Aydin ME, Tekin E, Ahiskalioglu EO, Ates I, Karagoz S, Aydin OF, Ozkaya F, Ahiskalioglu A. Erector spinae plane block vs non-steroidal anti-inflammatory drugs for severe renal colic pain: A pilot clinical feasibility study. Int J Clin Pract. 2021 Mar;75(3):e13789. doi: 10.1111/ijcp.13789. Epub 2020 Nov 9.
PubMed 33099855
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Erector Spinae Plane (ESP) Block Better Relieve Acute Renal Colic Pain Than Standard of Care
- ClinicalTrials.gov ID
- NCT05323175
- Acronym / sponsor ID
- IRB2021-00518
- Conditions
- Renal Colic
- Keywords
- Erector spinae plane block
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Stony Brook UniversityUniversity, hospital or other
- Study start
- 25 Apr 2022 (actual)
- Primary completion
- 9 Jan 2026 (actual)
- Study completion
- 9 Jan 2026 (actual)
- First posted
- 12 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Comparing standard of care to erector spinae plane block for acute renal colic pain.
Detailed description
Will compare at times 0, 10 minute, 20 minute, 40 minute and 60 minutes after local nerve block given.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Standard of care group + sham normal saline ESP block vs Standard of care + Ropivacaine ESP nerve Block group
| Arm | Type | Receives |
|---|---|---|
| ESP Nerve Block for Renal colic | Active comparator | Drug: Ropivacaine injectionOn top of receiving standard of care, At T8 nerve level, with ultrasound guidance to bathe the nerve |
| Standard of care | Active comparator | Other: Standard of care medicationsWhatever medications the clinician normally treats renal colic with |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 to 65 years old
- ASA Level I and II
- flank pain concerning for renal colic in ED
Key exclusion criteria (12 listed)
- pregnant women
- subjects unable to appreciate ESP block landmarks under ultrasound
- skin infection over needle site insertion
- Allergy to local anesthesia (lidocaine/Ropivacaine)
- bleeding disorders
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 |
|---|---|---|
| Ropivacaine injectionLocal anesthesia injected under ultrasound guidance | Drug | ESP Nerve Block for Renal colic |
| Standard of care medicationsWhatever the ED clinicians normally give for renal colic pain | Other | Standard of care |
Primary outcome
Baseline Pain before intervention
Time frame: Before the ESP Block
Using the Visual Analog Scale for Pain Assessment Tool with 0 meaning "No pain" and 10 meaning "Unbearable Pain"
Pain score at 10 minutes
Time frame: 10 minutes after the ESP Block
Using the Visual Analog Scale for Pain Assessment Tool with 0 meaning "No pain" and 10 meaning "Unbearable Pain"
Pain score at 20 minutes
Time frame: 20 minutes after ESP Block
Using the Visual Analog Scale for Pain Assessment Tool with 0 meaning "No pain" and 10 meaning "Unbearable Pain"
Pain score at 40 minutes
Time frame: 40 minutes after ESP Block
Using the Visual Analog Scale for Pain Assessment Tool with 0 meaning "No pain" and 10 meaning "Unbearable Pain
Pain score at 60 minutes
Time frame: 60 minutes after ESP Block
Using the Visual Analog Scale for Pain Assessment Tool with 0 meaning "No pain" and 10 meaning "Unbearable Pain
1 secondary outcome
Need for extra opiates
Time frame: Starting from time 0 after the ESP Block intervention completed till discharge or urology intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2026.
- Background: PubMed 33099855Aydin ME, Tekin E, Ahiskalioglu EO, Ates I, Karagoz S, Aydin OF, Ozkaya F, Ahiskalioglu A. Erector spinae plane block vs non-steroidal anti-inflammatory drugs for severe renal colic pain: A pilot clinical feasibility study. Int J Clin Pract. 2021 Mar;75(3):e13789. doi: 10.1111/ijcp.13789. Epub 2020 Nov 9.
- 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.
Michael Secko, MD principal investigator
StonyBrook University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ropivacaine injection in people with Renal Colic, run by Stony Brook University 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 3 inclusion and 12 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 3 Jun 2026. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Baseline Pain before intervention (time frame: Before the ESP Block). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05323175, which also lists 1 linked publication.
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 3 Jun 2026.