Trial Outcomes & Findings for Erector Spinae Plane Block (ESPB): in Patients Undergoing Surgery Through a Flank or Anterior Subcostal Incision. (NCT NCT03691935)
NCT ID: NCT03691935
Last Updated: 2025-02-10
Results Overview
Data will be collected via the electronic medical record and begin following patient randomization. The Visual Analogue Scale pain scales will be administered and collected on Post Operative Days 1, 2 and 3. Minimum value = 0 No Pain, Maximum value = 10 Worst possible, unbearable, excruciating pain
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
20 participants
Primary outcome timeframe
Aggregate pain scores for average length of hospital stay which is 3 days
Results posted on
2025-02-10
Participant Flow
Participant milestones
| Measure |
Ropivicaine
Erector Spinae Block of 20ml 0.5% ropivicaine bolus, connected to a pump containing 0.2% ropivicaine receiving 15ml every 3 hrs.
Ropivacaine: Erector Spinae Block with ropivacaine infusion with standard of care analgesics for perioperative pain control
|
Normal Saline
Erector Spinae Block of 20ml normal saline placebo bolus, then connected to pump of normal saline receiving 15ml every 3 hrs.
Normal saline: Erector Spinae Block with saline infusion with standard of care analgesics for for perioperative pain control
|
|---|---|---|
|
Overall Study
STARTED
|
11
|
9
|
|
Overall Study
COMPLETED
|
6
|
8
|
|
Overall Study
NOT COMPLETED
|
5
|
1
|
Reasons for withdrawal
| Measure |
Ropivicaine
Erector Spinae Block of 20ml 0.5% ropivicaine bolus, connected to a pump containing 0.2% ropivicaine receiving 15ml every 3 hrs.
Ropivacaine: Erector Spinae Block with ropivacaine infusion with standard of care analgesics for perioperative pain control
|
Normal Saline
Erector Spinae Block of 20ml normal saline placebo bolus, then connected to pump of normal saline receiving 15ml every 3 hrs.
Normal saline: Erector Spinae Block with saline infusion with standard of care analgesics for for perioperative pain control
|
|---|---|---|
|
Overall Study
Physician Decision
|
2
|
1
|
|
Overall Study
Adverse Event
|
3
|
0
|
Baseline Characteristics
Erector Spinae Plane Block (ESPB): in Patients Undergoing Surgery Through a Flank or Anterior Subcostal Incision.
Baseline characteristics by cohort
| Measure |
Ropivicaine
n=11 Participants
Erector Spinae Block of 20ml 0.5% ropivicaine bolus, connected to a pump containing 0.2% ropivicaine receiving 15ml every 3 hrs.
Ropivacaine: Erector Spinae Block with ropivacaine infusion with standard of care analgesics for perioperative pain control
|
Normal Saline
n=9 Participants
Erector Spinae Block of 20ml normal saline placebo bolus, then connected to pump of normal saline receiving 15ml every 3 hrs.
Normal saline: Erector Spinae Block with saline infusion with standard of care analgesics for for perioperative pain control
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
57 years
STANDARD_DEVIATION 13 • n=99 Participants
|
61 years
STANDARD_DEVIATION 9.2 • n=107 Participants
|
59 years
STANDARD_DEVIATION 11 • n=206 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
10 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
19 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
11 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
19 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
11 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
20 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Aggregate pain scores for average length of hospital stay which is 3 daysData will be collected via the electronic medical record and begin following patient randomization. The Visual Analogue Scale pain scales will be administered and collected on Post Operative Days 1, 2 and 3. Minimum value = 0 No Pain, Maximum value = 10 Worst possible, unbearable, excruciating pain
Outcome measures
| Measure |
Ropivicaine
n=6 Participants
Erector Spinae Block of 20ml 0.5% ropivicaine bolus, connected to a pump containing 0.2% ropivicaine receiving 15ml every 3 hrs.
Ropivacaine: Erector Spinae Block with ropivacaine infusion with standard of care analgesics for perioperative pain control
|
Normal Saline
n=8 Participants
Erector Spinae Block of 20ml normal saline placebo bolus, then connected to pump of normal saline receiving 15ml every 3 hrs.
Normal saline: Erector Spinae Block with saline infusion with standard of care analgesics for for perioperative pain control
|
|---|---|---|
|
Pain Scores Using the Visual Analogue Pain Scale From Zero Pain to Level Ten Pain
|
3.55 units on a scale
Standard Deviation 1.2
|
4.6 units on a scale
Standard Deviation 2.15
|
Adverse Events
Ropivicaine
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Normal Saline
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Ropivicaine
n=11 participants at risk
Erector Spinae Block of 20ml 0.5% ropivicaine bolus, connected to a pump containing 0.2% ropivicaine receiving 15ml every 3 hrs.
Ropivacaine: Erector Spinae Block with ropivacaine infusion with standard of care analgesics for perioperative pain control
|
Normal Saline
n=9 participants at risk
Erector Spinae Block of 20ml normal saline placebo bolus, then connected to pump of normal saline receiving 15ml every 3 hrs.
Normal saline: Erector Spinae Block with saline infusion with standard of care analgesics for for perioperative pain control
|
|---|---|---|
|
Gastrointestinal disorders
Post-op ileus
|
9.1%
1/11 • Number of events 1 • From enrollment to 14 days post-op for each subject
|
0.00%
0/9 • From enrollment to 14 days post-op for each subject
|
Other adverse events
| Measure |
Ropivicaine
n=11 participants at risk
Erector Spinae Block of 20ml 0.5% ropivicaine bolus, connected to a pump containing 0.2% ropivicaine receiving 15ml every 3 hrs.
Ropivacaine: Erector Spinae Block with ropivacaine infusion with standard of care analgesics for perioperative pain control
|
Normal Saline
n=9 participants at risk
Erector Spinae Block of 20ml normal saline placebo bolus, then connected to pump of normal saline receiving 15ml every 3 hrs.
Normal saline: Erector Spinae Block with saline infusion with standard of care analgesics for for perioperative pain control
|
|---|---|---|
|
General disorders
Increased pain
|
27.3%
3/11 • Number of events 3 • From enrollment to 14 days post-op for each subject
|
11.1%
1/9 • Number of events 1 • From enrollment to 14 days post-op for each subject
|
Additional Information
Urology Research Operations Manager
Milton S. Hershey Medical Center
Phone: 717-531-0003
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place