Trial Outcomes & Findings for Erector Spinae Plane Block for Uncomplicated Renal Colic (NCT NCT05625802)

Last Updated: 2025-10-30

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

5 participants

Primary outcome timeframe

By ED discharge, approximately 12 hours or less

Results posted on

2025-10-30

Participant Flow

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.

Participant milestones

Participant milestones
Measure	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	External control Control patient data (external controls that did not receive ESPB), routinely collected health information, collected as secondary data.
Overall Study STARTED	5	0
Overall Study COMPLETED	4	0
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Reasons for withdrawal
Measure	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	External control Control patient data (external controls that did not receive ESPB), routinely collected health information, collected as secondary data.
Overall Study Lost to Follow-up	1	0

Baseline Characteristics

Erector Spinae Plane Block for Uncomplicated Renal Colic

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Erector Spinae Plane Block (ESPB) n=5 Participants 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
Age, Continuous	37.4 years STANDARD_DEVIATION 11.1 • n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	5 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	5 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	5 Participants n=5 Participants
First paraenteral pain medicine Ketorolac	4 Participants n=5 Participants
First paraenteral pain medicine Morphine	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Erector Spinae Plane Block (ESPB) n=5 Participants 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
Participants Who Received a Second Parenteral Pain Medication in the Emergency Department (ED)	0 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Erector Spinae Plane Block (ESPB) n=5 Participants 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
Change in Pain Baseline	3.2 score on a scale Standard Deviation 3.1
Change in Pain 5 minutes following	1.8 score on a scale Standard Deviation 1.8
Change in Pain 60 minutes following procedure	1.8 score on a scale Standard Deviation 1.8

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Erector Spinae Plane Block (ESPB) n=5 Participants 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
Rate of Admission to Hospital for Kidney Stones 7 days	2 Participants
Rate of Admission to Hospital for Kidney Stones 30 days	1 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Erector Spinae Plane Block (ESPB) n=5 Participants 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
Rate of 24-hour and 72-hour Return to the Emergency Department (ED) 24 hours	0 Participants
Rate of 24-hour and 72-hour Return to the Emergency Department (ED) 72 hours	0 Participants

SECONDARY outcome

Timeframe: Up to 30 days

Average length of stay in the emergency department per participant.

Outcome measures

Outcome measures
Measure	Erector Spinae Plane Block (ESPB) n=5 Participants 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
Emergency Department Length of Stay	418 minutes Standard Deviation 183

SECONDARY outcome

Timeframe: Up to 30 days

Population: 1 participant was lost to follow up prior to Day 30.

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.

Outcome measures

Outcome measures
Measure	Erector Spinae Plane Block (ESPB) n=4 Participants 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
Safety Outcomes and Complications Admission to hospital due to nerve block complication	0 Participants
Safety Outcomes and Complications Injury to a blood vessel that is permanent	0 Participants
Safety Outcomes and Complications Injury to a nerve that is permanent	0 Participants
Safety Outcomes and Complications Injury to blood vessel that required surgery	0 Participants
Safety Outcomes and Complications Injury to lung that required surgery	0 Participants
Safety Outcomes and Complications Infection of the skin, muscle of soft tissue of back	0 Participants
Safety Outcomes and Complications Allergic reaction to medicine used for nerve block	0 Participants
Safety Outcomes and Complications Other reaction to medicine used for nerve block	0 Participants

Adverse Events

Erector Spinae Plane Block (ESPB)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

External control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Christopher Fung

University of Michigan

Phone: 734-763-4091

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place