Renal Colic, Kidney Stone
Conditions
Keywords
erector spinae plane block, Emergency Department, ropivacaine
Brief 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.
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.
Interventions
PROCEDUREErector 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
DRUGRopivacaine
0.5% ropivacaine
Sponsors
University of Michigan
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
Single site two-stage open label phase 2 clinical trial with one treatment arm and one external control arm
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Participants Who Received a Second Parenteral Pain Medication in the Emergency Department (ED) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Pain | Baseline, 5 minutes, and 60 minutes following procedure | 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. |
| Rate of Admission to Hospital for Kidney Stones | Up to 30 days | 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. |
| Rate of 24-hour and 72-hour Return to the Emergency Department (ED) | Up to 72 hours | 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. |
| Emergency Department Length of Stay | Up to 30 days | Average length of stay in the emergency department per participant. |
| Safety Outcomes and Complications | Up to 30 days | 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. |
Countries
United States
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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 | 5 |
| Total | 5 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 0 |
Baseline characteristics
| Characteristic | Erector Spinae Plane Block (ESPB) |
|---|---|
| Age, Continuous | 37.4 years STANDARD_DEVIATION 11.1 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 5 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| First paraenteral pain medicine Ketorolac | 4 Participants |
| First paraenteral pain medicine Morphine | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 5 Participants |
| Region of Enrollment United States | 5 Participants |
| Sex: Female, Male Female | 3 Participants |
| Sex: Female, Male Male | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 5 | 0 / 0 |
| other Total, other adverse events | 0 / 5 | 0 / 0 |
| serious Total, serious adverse events | 0 / 5 | 0 / 0 |
Outcome results
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.
Time frame: By ED discharge, approximately 12 hours or less
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Erector Spinae Plane Block (ESPB) | Participants Who Received a Second Parenteral Pain Medication in the Emergency Department (ED) | 0 Participants |
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.
Time frame: Baseline, 5 minutes, and 60 minutes following procedure
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Erector Spinae Plane Block (ESPB) | Change in Pain | Baseline | 3.2 score on a scale | Standard Deviation 3.1 |
| Erector Spinae Plane Block (ESPB) | Change in Pain | 5 minutes following | 1.8 score on a scale | Standard Deviation 1.8 |
| Erector Spinae Plane Block (ESPB) | Change in Pain | 60 minutes following procedure | 1.8 score on a scale | Standard Deviation 1.8 |
Secondary
Emergency Department Length of Stay
Average length of stay in the emergency department per participant.
Time frame: Up to 30 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Erector Spinae Plane Block (ESPB) | Emergency Department Length of Stay | 418 minutes | Standard Deviation 183 |
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.
Time frame: Up to 72 hours
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Erector Spinae Plane Block (ESPB) | Rate of 24-hour and 72-hour Return to the Emergency Department (ED) | 24 hours | 0 Participants |
| Erector Spinae Plane Block (ESPB) | Rate of 24-hour and 72-hour Return to the Emergency Department (ED) | 72 hours | 0 Participants |
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.
Time frame: Up to 30 days
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Erector Spinae Plane Block (ESPB) | Rate of Admission to Hospital for Kidney Stones | 7 days | 2 Participants |
| Erector Spinae Plane Block (ESPB) | Rate of Admission to Hospital for Kidney Stones | 30 days | 1 Participants |
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.
Time frame: Up to 30 days
Population: 1 participant was lost to follow up prior to Day 30.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Erector Spinae Plane Block (ESPB) | Safety Outcomes and Complications | Admission to hospital due to nerve block complication | 0 Participants |
| Erector Spinae Plane Block (ESPB) | Safety Outcomes and Complications | Injury to a blood vessel that is permanent | 0 Participants |
| Erector Spinae Plane Block (ESPB) | Safety Outcomes and Complications | Injury to a nerve that is permanent | 0 Participants |
| Erector Spinae Plane Block (ESPB) | Safety Outcomes and Complications | Injury to blood vessel that required surgery | 0 Participants |
| Erector Spinae Plane Block (ESPB) | Safety Outcomes and Complications | Injury to lung that required surgery | 0 Participants |
| Erector Spinae Plane Block (ESPB) | Safety Outcomes and Complications | Infection of the skin, muscle of soft tissue of back | 0 Participants |
| Erector Spinae Plane Block (ESPB) | Safety Outcomes and Complications | Allergic reaction to medicine used for nerve block | 0 Participants |
| Erector Spinae Plane Block (ESPB) | Safety Outcomes and Complications | Other reaction to medicine used for nerve block | 0 Participants |