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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | By ED discharge, approximately 12 hours or less |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, 5 minutes, and 60 minutes following procedure |
| Rate of Admission to Hospital for Kidney Stones |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chris Fung | University of Michigan | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Michigan | Ann Arbor | Michigan | 48109 | United States |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Erector Spinae Plane Block (ESPB) | 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 Ropivacaine: 0.5% ropivacaine |
| FG001 | External control | Control patient data (external controls that did not receive ESPB), routinely collected health information, collected as secondary data. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Erector Spinae Plane Block (ESPB) | 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 Ropivacaine: 0.5% ropivacaine |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Count of Participants | Participants | By ED discharge, approximately 12 hours or less |
|
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Up to 30 days
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Erector Spinae Plane Block (ESPB) | 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 Ropivacaine: 0.5% ropivacaine |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Christopher Fung | University of Michigan | 734-763-4091 | chfung@med.umich.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 6, 2022 | Sep 23, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D056844 | Renal Colic |
| D007669 | Kidney Calculi |
| D004630 | Emergencies |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000077212 | Ropivacaine |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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Single site two-stage open label phase 2 clinical trial with one treatment arm and one external control arm
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| Ropivacaine | Drug | 0.5% ropivacaine |
|
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. |
| 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. | Up to 72 hours |
| Emergency Department Length of Stay | Average length of stay in the emergency department per participant. | 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. | Up to 30 days |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| First paraenteral pain medicine | Initial paraenteral pain medicine taken by participants. | Count of Participants | Participants |
|
| Participants |
|
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| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 5 minutes, and 60 minutes following procedure |
|
|
|
| Secondary | 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. | Data was only collected for participants who were still in the trial by day 7 and day 30. 1 participant was lost to follow up before day 30. | Posted | Count of Participants | Participants | Up to 30 days |
|
|
|
| Secondary | 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. | Posted | Count of Participants | Participants | Up to 72 hours |
|
|
|
| Secondary | Emergency Department Length of Stay | Average length of stay in the emergency department per participant. | Posted | Mean | Standard Deviation | minutes | Up to 30 days |
|
|
|
| Secondary | 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. | 1 participant was lost to follow up prior to Day 30. | Posted | Count of Participants | Participants | Up to 30 days |
|
|
|
| 0 |
| 5 |
| 0 |
| 5 |
| 0 |
| 5 |
| EG001 | External control | Control patient data (external controls that did not receive ESPB), routinely collected health information, collected as secondary data. | 0 | 0 | 0 | 0 | 0 | 0 |
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| D053040 | Nephrolithiasis |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052878 | Urolithiasis |
| D014545 | Urinary Calculi |
| D052801 | Male Urogenital Diseases |
| D002137 | Calculi |
| D020763 | Pathological Conditions, Anatomical |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D000588 |
| Amines |
| Title | Measurements |
|---|---|
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| Title | Measurements |
|---|---|
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| Injury to blood vessel that required surgery |
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| Injury to lung that required surgery |
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| Infection of the skin, muscle of soft tissue of back |
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| Allergic reaction to medicine used for nerve block |
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| Other reaction to medicine used for nerve block |
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