Trial Outcomes & Findings for Continuous Erector Spinae Plane Blocks for Rib Fractures (NCT NCT04558281)
NCT ID: NCT04558281
Last Updated: 2023-06-12
Results Overview
Measured via a handheld incentive spirometer. The best of three measurements will be recorded as the maximum inspired volume.
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
4 participants
Primary outcome timeframe
Between 1200 and 1700 on the day following the procedure
Results posted on
2023-06-12
Participant Flow
Participant milestones
| Measure |
Active Treatment
This group will receive a single injection nerve block of ropivacaine 0.5% (20 mL) followed by an infusion/boluses of ropivacaine 0.3% (continuous block)
Active ropivacaine 0.3% erector spinae plane perineural administration: Ropivacaine 0.3% administration via an erector spinae plane perineural catheter
|
Placebo
This group will receive a single injection nerve block of ropivacaine 0.5% (20 mL) followed by an infusion/boluses of normal saline
Placebo erector spinae plane perineural administration: Normal saline administration via an erector spinae plane perineural catheter
|
|---|---|---|
|
Overall Study
STARTED
|
2
|
2
|
|
Overall Study
COMPLETED
|
2
|
2
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Active Treatment
n=2 Participants
This group will receive a single injection nerve block of ropivacaine 0.5% (20 mL) followed by an infusion/boluses of ropivacaine 0.3% (continuous block)
Active ropivacaine 0.3% erector spinae plane perineural administration: Ropivacaine 0.3% administration via an erector spinae plane perineural catheter
|
Placebo
n=2 Participants
This group will receive a single injection nerve block of ropivacaine 0.5% (20 mL) followed by an infusion/boluses of normal saline
Placebo erector spinae plane perineural administration: Normal saline administration via an erector spinae plane perineural catheter
|
Total
n=4 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
38.5 years
STANDARD_DEVIATION 3.5 • n=2 Participants
|
40.5 years
STANDARD_DEVIATION 21.9 • n=2 Participants
|
39.5 years
STANDARD_DEVIATION 13.2 • n=4 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=2 Participants
|
1 Participants
n=2 Participants
|
2 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=2 Participants
|
1 Participants
n=2 Participants
|
2 Participants
n=4 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
2 participants
n=2 Participants
|
2 participants
n=2 Participants
|
4 participants
n=4 Participants
|
|
Height
|
1.8 meters
STANDARD_DEVIATION 0.1 • n=2 Participants
|
1.7 meters
STANDARD_DEVIATION 83.7 • n=2 Participants
|
1.75 meters
STANDARD_DEVIATION 43.2 • n=4 Participants
|
|
Weight
|
83.7 kg
STANDARD_DEVIATION 16.5 • n=2 Participants
|
68.4 kg
STANDARD_DEVIATION 12.1 • n=2 Participants
|
73 kg
STANDARD_DEVIATION 14.2 • n=4 Participants
|
PRIMARY outcome
Timeframe: Between 1200 and 1700 on the day following the procedureMeasured via a handheld incentive spirometer. The best of three measurements will be recorded as the maximum inspired volume.
Outcome measures
| Measure |
Active Treatment
n=2 Participants
This group will receive a single injection nerve block of ropivacaine 0.5% (20 mL) followed by an infusion/boluses of ropivacaine 0.3% (continuous block)
Active ropivacaine 0.3% erector spinae plane perineural administration: Ropivacaine 0.3% administration via an erector spinae plane perineural catheter
|
Placebo
n=2 Participants
This group will receive a single injection nerve block of ropivacaine 0.5% (20 mL) followed by an infusion/boluses of normal saline
Placebo erector spinae plane perineural administration: Normal saline administration via an erector spinae plane perineural catheter
|
|---|---|---|
|
Maximal Inspired Volume - Absolute
|
2500 mL
Standard Deviation 707
|
2625 mL
Standard Deviation 530
|
SECONDARY outcome
Timeframe: Afternoons on postoperative days 2 and 7, postoperative months 0.5, 1, 1.5, 2, 3, 6, and 12Population: At two time points, neither patient in the treatment group could be reached or no longer had the incentive spirometer to produce the measurement.
Measured via a handheld incentive spirometer. The best of three measurements will be recorded as the maximum inspired volume.
Outcome measures
| Measure |
Active Treatment
n=2 Participants
This group will receive a single injection nerve block of ropivacaine 0.5% (20 mL) followed by an infusion/boluses of ropivacaine 0.3% (continuous block)
Active ropivacaine 0.3% erector spinae plane perineural administration: Ropivacaine 0.3% administration via an erector spinae plane perineural catheter
|
Placebo
n=2 Participants
This group will receive a single injection nerve block of ropivacaine 0.5% (20 mL) followed by an infusion/boluses of normal saline
Placebo erector spinae plane perineural administration: Normal saline administration via an erector spinae plane perineural catheter
|
|---|---|---|
|
Maximal Inspired Volume - Absolute
Day 2
|
2375 mL
Standard Deviation 1237
|
2500 mL
Standard Deviation 707
|
|
Maximal Inspired Volume - Absolute
Day 7
|
2750 mL
Standard Deviation 707
|
2750 mL
Standard Deviation 707
|
|
Maximal Inspired Volume - Absolute
Day 14
|
3250 mL
Standard Deviation 354
|
3125 mL
Standard Deviation 177
|
|
Maximal Inspired Volume - Absolute
Month 1
|
3500 mL
Standard Deviation 0
|
3250 mL
Standard Deviation 0
|
|
Maximal Inspired Volume - Absolute
Month 1.5
|
3375 mL
Standard Deviation 177
|
3375 mL
Standard Deviation 177
|
|
Maximal Inspired Volume - Absolute
Month 2
|
3500 mL
Standard Deviation 0
|
3625 mL
Standard Deviation 177
|
|
Maximal Inspired Volume - Absolute
Month 3
|
—
|
3875 mL
Standard Deviation 177
|
|
Maximal Inspired Volume - Absolute
Month 6
|
3500 mL
Standard Deviation 0
|
4000 mL
Standard Deviation 0
|
SECONDARY outcome
Timeframe: Afternoons on postoperative days 1, 2 and 7, postoperative months 0.5, 1, 1.5, 2, 3, 6, and 12Population: Some patients could not be reached or no longer had their incentive spirometer to measure the outcome
Measured via a handheld incentive spirometer. The best of three measurements will be recorded as the maximum inspired volume.
Outcome measures
| Measure |
Active Treatment
n=2 Participants
This group will receive a single injection nerve block of ropivacaine 0.5% (20 mL) followed by an infusion/boluses of ropivacaine 0.3% (continuous block)
Active ropivacaine 0.3% erector spinae plane perineural administration: Ropivacaine 0.3% administration via an erector spinae plane perineural catheter
|
Placebo
n=2 Participants
This group will receive a single injection nerve block of ropivacaine 0.5% (20 mL) followed by an infusion/boluses of normal saline
Placebo erector spinae plane perineural administration: Normal saline administration via an erector spinae plane perineural catheter
|
|---|---|---|
|
Maximal Inspired Volume - Percentage Change From Baseline Prior to Intervention
Day 1
|
283 percentage change
Standard Deviation 24
|
263 percentage change
Standard Deviation 53
|
|
Maximal Inspired Volume - Percentage Change From Baseline Prior to Intervention
Day 2
|
200 percentage change
Standard Deviation 0
|
250 percentage change
Standard Deviation 71
|
|
Maximal Inspired Volume - Percentage Change From Baseline Prior to Intervention
Day 7
|
2750 percentage change
Standard Deviation 707
|
2750 percentage change
Standard Deviation 707
|
|
Maximal Inspired Volume - Percentage Change From Baseline Prior to Intervention
Day 14
|
375 percentage change
Standard Deviation 35
|
313 percentage change
Standard Deviation 18
|
|
Maximal Inspired Volume - Percentage Change From Baseline Prior to Intervention
Month 1
|
3500 percentage change
Standard Deviation 0
|
3250 percentage change
Standard Deviation 0
|
|
Maximal Inspired Volume - Percentage Change From Baseline Prior to Intervention
Month 1.5
|
392 percentage change
Standard Deviation 59
|
338 percentage change
Standard Deviation 18
|
|
Maximal Inspired Volume - Percentage Change From Baseline Prior to Intervention
Month 2
|
467 percentage change
Standard Deviation 0
|
363 percentage change
Standard Deviation 0
|
|
Maximal Inspired Volume - Percentage Change From Baseline Prior to Intervention
Month 3
|
—
|
388 percentage change
Standard Deviation 18
|
|
Maximal Inspired Volume - Percentage Change From Baseline Prior to Intervention
Month 6
|
467 percentage change
Standard Deviation 0
|
400 percentage change
Standard Deviation 0
|
SECONDARY outcome
Timeframe: Months 0.5, 1, 1.5, 2, 3, 6, 12 following procedureThe Brief Pain Inventory (short form, Interference scale) is an instrument specifically designed to assess pain and its impact on physical and emotional functioning \[7 questions related specifically to rib fracture pain and not other injuries\]. We calculated the total score of the 7 questions combined. The minimum is zero (no interference, better outcome) and the maximum is 70 (maximum interference, worse outcome).
Outcome measures
| Measure |
Active Treatment
n=2 Participants
This group will receive a single injection nerve block of ropivacaine 0.5% (20 mL) followed by an infusion/boluses of ropivacaine 0.3% (continuous block)
Active ropivacaine 0.3% erector spinae plane perineural administration: Ropivacaine 0.3% administration via an erector spinae plane perineural catheter
|
Placebo
n=2 Participants
This group will receive a single injection nerve block of ropivacaine 0.5% (20 mL) followed by an infusion/boluses of normal saline
Placebo erector spinae plane perineural administration: Normal saline administration via an erector spinae plane perineural catheter
|
|---|---|---|
|
Brief Pain Inventory (Short Form, Interference Subscale)
Month 12
|
0 score on a scale
Standard Deviation 0
|
0 score on a scale
Standard Deviation 0
|
|
Brief Pain Inventory (Short Form, Interference Subscale)
Month 0.5
|
33 score on a scale
Standard Deviation 9.9
|
5 score on a scale
Standard Deviation 1.4
|
|
Brief Pain Inventory (Short Form, Interference Subscale)
Month 1
|
2 score on a scale
Standard Deviation 2.8
|
1 score on a scale
Standard Deviation 1.4
|
|
Brief Pain Inventory (Short Form, Interference Subscale)
Month 1.5
|
8 score on a scale
Standard Deviation 11.3
|
0 score on a scale
Standard Deviation 0
|
|
Brief Pain Inventory (Short Form, Interference Subscale)
Month 2
|
0 score on a scale
Standard Deviation 0
|
0 score on a scale
Standard Deviation 0
|
|
Brief Pain Inventory (Short Form, Interference Subscale)
Month 3
|
0 score on a scale
Standard Deviation 0
|
0 score on a scale
Standard Deviation 0
|
|
Brief Pain Inventory (Short Form, Interference Subscale)
Month 6
|
0 score on a scale
Standard Deviation 0
|
0 score on a scale
Standard Deviation 0
|
SECONDARY outcome
Timeframe: Days 1, 2, and 7, and months 0.5, 1, 1.5, 2, 3, 6, 12 following procedurePopulation: Patients could not be reached at all timepoints and therefore data could not be collected.
Pain rated from 0-10 using a Numeric Rating Scale with 0 equivalent to no pain and 10 equivalent to the worst imaginable pain
Outcome measures
| Measure |
Active Treatment
n=2 Participants
This group will receive a single injection nerve block of ropivacaine 0.5% (20 mL) followed by an infusion/boluses of ropivacaine 0.3% (continuous block)
Active ropivacaine 0.3% erector spinae plane perineural administration: Ropivacaine 0.3% administration via an erector spinae plane perineural catheter
|
Placebo
n=2 Participants
This group will receive a single injection nerve block of ropivacaine 0.5% (20 mL) followed by an infusion/boluses of normal saline
Placebo erector spinae plane perineural administration: Normal saline administration via an erector spinae plane perineural catheter
|
|---|---|---|
|
Rib Fracture Pain When Using an Incentive Spirometer
Month 12
|
0 score on a scale
Standard Deviation 0
|
0 score on a scale
Standard Deviation 0
|
|
Rib Fracture Pain When Using an Incentive Spirometer
Day 1
|
5.0 score on a scale
Standard Deviation 0
|
5 score on a scale
Standard Deviation 1.4
|
|
Rib Fracture Pain When Using an Incentive Spirometer
Day 2
|
6.0 score on a scale
Standard Deviation 1.4
|
4.5 score on a scale
Standard Deviation 2.1
|
|
Rib Fracture Pain When Using an Incentive Spirometer
Day 7
|
5 score on a scale
Standard Deviation 1.4
|
4 score on a scale
Standard Deviation 0
|
|
Rib Fracture Pain When Using an Incentive Spirometer
Month 0.5
|
3.5 score on a scale
Standard Deviation 0.7
|
3 score on a scale
Standard Deviation 1.4
|
|
Rib Fracture Pain When Using an Incentive Spirometer
Month 1
|
0 score on a scale
Standard Deviation 0
|
0 score on a scale
Standard Deviation 0
|
|
Rib Fracture Pain When Using an Incentive Spirometer
Month 1.5
|
4 score on a scale
Standard Deviation 4.2
|
0 score on a scale
Standard Deviation 0
|
|
Rib Fracture Pain When Using an Incentive Spirometer
Month 2
|
0 score on a scale
Standard Deviation 0
|
0 score on a scale
Standard Deviation 0
|
|
Rib Fracture Pain When Using an Incentive Spirometer
Month 3
|
0 score on a scale
Standard Deviation 0
|
0 score on a scale
Standard Deviation 0
|
|
Rib Fracture Pain When Using an Incentive Spirometer
Month 6
|
0 score on a scale
Standard Deviation 0
|
0 score on a scale
Standard Deviation 0
|
SECONDARY outcome
Timeframe: Days 1, 2, and 7, and months 0.5, 1, 1.5, 2, 3, 6, 12 following procedurePain rated from 0-10 using a Numeric Rating Scale with 0 equivalent to no pain and 10 equivalent to the worst imaginable pain
Outcome measures
| Measure |
Active Treatment
n=2 Participants
This group will receive a single injection nerve block of ropivacaine 0.5% (20 mL) followed by an infusion/boluses of ropivacaine 0.3% (continuous block)
Active ropivacaine 0.3% erector spinae plane perineural administration: Ropivacaine 0.3% administration via an erector spinae plane perineural catheter
|
Placebo
n=2 Participants
This group will receive a single injection nerve block of ropivacaine 0.5% (20 mL) followed by an infusion/boluses of normal saline
Placebo erector spinae plane perineural administration: Normal saline administration via an erector spinae plane perineural catheter
|
|---|---|---|
|
WORST Rib Fracture Pain in Previous 24 Hours
Day 1
|
9 score on a scale
Standard Deviation 1.4
|
5.8 score on a scale
Standard Deviation 2.5
|
|
WORST Rib Fracture Pain in Previous 24 Hours
Day 2
|
9 score on a scale
Standard Deviation 1.4
|
7 score on a scale
Standard Deviation 0
|
|
WORST Rib Fracture Pain in Previous 24 Hours
Day 7
|
7.5 score on a scale
Standard Deviation 0.7
|
7 score on a scale
Standard Deviation 1.4
|
|
WORST Rib Fracture Pain in Previous 24 Hours
Month 0.5
|
5 score on a scale
Standard Deviation 1.4
|
4 score on a scale
Standard Deviation 0
|
|
WORST Rib Fracture Pain in Previous 24 Hours
Month 1
|
1 score on a scale
Standard Deviation 0
|
1 score on a scale
Standard Deviation 1.4
|
|
WORST Rib Fracture Pain in Previous 24 Hours
Month 1.5
|
2 score on a scale
Standard Deviation 1.4
|
0.5 score on a scale
Standard Deviation .7
|
|
WORST Rib Fracture Pain in Previous 24 Hours
Month 2
|
1 score on a scale
Standard Deviation 1.4
|
0 score on a scale
Standard Deviation 0
|
|
WORST Rib Fracture Pain in Previous 24 Hours
Month 3
|
1 score on a scale
Standard Deviation 0
|
0 score on a scale
Standard Deviation 0
|
|
WORST Rib Fracture Pain in Previous 24 Hours
Month 6
|
0 score on a scale
Standard Deviation 0
|
0 score on a scale
Standard Deviation 0
|
|
WORST Rib Fracture Pain in Previous 24 Hours
Month 12
|
0 score on a scale
Standard Deviation 0
|
0 score on a scale
Standard Deviation 0
|
SECONDARY outcome
Timeframe: Days 1, 2, and 7, and months 0.5, 1, 1.5, 2, 3, 6, 12 following procedurePain rated from 0-10 using a Numeric Rating Scale with 0 equivalent to no pain and 10 equivalent to the worst imaginable pain
Outcome measures
| Measure |
Active Treatment
n=2 Participants
This group will receive a single injection nerve block of ropivacaine 0.5% (20 mL) followed by an infusion/boluses of ropivacaine 0.3% (continuous block)
Active ropivacaine 0.3% erector spinae plane perineural administration: Ropivacaine 0.3% administration via an erector spinae plane perineural catheter
|
Placebo
n=2 Participants
This group will receive a single injection nerve block of ropivacaine 0.5% (20 mL) followed by an infusion/boluses of normal saline
Placebo erector spinae plane perineural administration: Normal saline administration via an erector spinae plane perineural catheter
|
|---|---|---|
|
AVERAGE Rib Fracture Pain in Previous 24 Hours
Day 1
|
3.5 score on a scale
Standard Deviation .7
|
4 score on a scale
Standard Deviation 2.8
|
|
AVERAGE Rib Fracture Pain in Previous 24 Hours
Day 2
|
5 score on a scale
Standard Deviation 0
|
3.5 score on a scale
Standard Deviation 2.1
|
|
AVERAGE Rib Fracture Pain in Previous 24 Hours
Day 7
|
3 score on a scale
Standard Deviation 0
|
4.5 score on a scale
Standard Deviation .7
|
|
AVERAGE Rib Fracture Pain in Previous 24 Hours
Month 0.5
|
2.5 score on a scale
Standard Deviation .7
|
1.5 score on a scale
Standard Deviation .7
|
|
AVERAGE Rib Fracture Pain in Previous 24 Hours
Month 1
|
0 score on a scale
Standard Deviation 0
|
0.5 score on a scale
Standard Deviation 0.7
|
|
AVERAGE Rib Fracture Pain in Previous 24 Hours
Month 1.5
|
.5 score on a scale
Standard Deviation .7
|
0 score on a scale
Standard Deviation 0
|
|
AVERAGE Rib Fracture Pain in Previous 24 Hours
Month 2
|
.5 score on a scale
Standard Deviation .7
|
0 score on a scale
Standard Deviation 0
|
|
AVERAGE Rib Fracture Pain in Previous 24 Hours
Month 3
|
0 score on a scale
Standard Deviation 0
|
0 score on a scale
Standard Deviation 0
|
|
AVERAGE Rib Fracture Pain in Previous 24 Hours
Month 6
|
0 score on a scale
Standard Deviation 0
|
0 score on a scale
Standard Deviation 0
|
|
AVERAGE Rib Fracture Pain in Previous 24 Hours
Month 12
|
0 score on a scale
Standard Deviation 0
|
0 score on a scale
Standard Deviation 0
|
SECONDARY outcome
Timeframe: Days 1, 2, and 7, and months 0.5, 1, 1.5, 2, 3, 6, 12 following procedurePain rated from 0-10 using a Numeric Rating Scale with 0 equivalent to no pain and 10 equivalent to the worst imaginable pain
Outcome measures
| Measure |
Active Treatment
n=2 Participants
This group will receive a single injection nerve block of ropivacaine 0.5% (20 mL) followed by an infusion/boluses of ropivacaine 0.3% (continuous block)
Active ropivacaine 0.3% erector spinae plane perineural administration: Ropivacaine 0.3% administration via an erector spinae plane perineural catheter
|
Placebo
n=2 Participants
This group will receive a single injection nerve block of ropivacaine 0.5% (20 mL) followed by an infusion/boluses of normal saline
Placebo erector spinae plane perineural administration: Normal saline administration via an erector spinae plane perineural catheter
|
|---|---|---|
|
LEAST Rib Fracture Pain in Previous 24 Hours
Day 1
|
.5 score on a scale
Standard Deviation .7
|
3 score on a scale
Standard Deviation 2.8
|
|
LEAST Rib Fracture Pain in Previous 24 Hours
Day 2
|
1.5 score on a scale
Standard Deviation .7
|
2 score on a scale
Standard Deviation 2.8
|
|
LEAST Rib Fracture Pain in Previous 24 Hours
Day 7
|
1 score on a scale
Standard Deviation 0
|
3 score on a scale
Standard Deviation 1.4
|
|
LEAST Rib Fracture Pain in Previous 24 Hours
Month 0.5
|
.5 score on a scale
Standard Deviation .7
|
0 score on a scale
Standard Deviation 0
|
|
LEAST Rib Fracture Pain in Previous 24 Hours
Month 1
|
0 score on a scale
Standard Deviation 0
|
0 score on a scale
Standard Deviation 0
|
|
LEAST Rib Fracture Pain in Previous 24 Hours
Month 1.5
|
0 score on a scale
Standard Deviation 0
|
0 score on a scale
Standard Deviation 0
|
|
LEAST Rib Fracture Pain in Previous 24 Hours
Month 2
|
0 score on a scale
Standard Deviation 0
|
0 score on a scale
Standard Deviation 0
|
|
LEAST Rib Fracture Pain in Previous 24 Hours
Month 3
|
0 score on a scale
Standard Deviation 0
|
0 score on a scale
Standard Deviation 0
|
|
LEAST Rib Fracture Pain in Previous 24 Hours
Month 6
|
0 score on a scale
Standard Deviation 0
|
0 score on a scale
Standard Deviation 0
|
|
LEAST Rib Fracture Pain in Previous 24 Hours
Month 12
|
0 score on a scale
Standard Deviation 0
|
0 score on a scale
Standard Deviation 0
|
SECONDARY outcome
Timeframe: Days 1, 2, and 7, and months 0.5, 1, 1.5, 2, 3, 6, 12 following procedurePain rated from 0-10 using a Numeric Rating Scale with 0 equivalent to no pain and 10 equivalent to the worst imaginable pain
Outcome measures
| Measure |
Active Treatment
n=2 Participants
This group will receive a single injection nerve block of ropivacaine 0.5% (20 mL) followed by an infusion/boluses of ropivacaine 0.3% (continuous block)
Active ropivacaine 0.3% erector spinae plane perineural administration: Ropivacaine 0.3% administration via an erector spinae plane perineural catheter
|
Placebo
n=2 Participants
This group will receive a single injection nerve block of ropivacaine 0.5% (20 mL) followed by an infusion/boluses of normal saline
Placebo erector spinae plane perineural administration: Normal saline administration via an erector spinae plane perineural catheter
|
|---|---|---|
|
CURRENT Rib Fracture Pain in Previous 24 Hours
Day 7
|
3.5 score on a scale
Standard Deviation .7
|
4.5 score on a scale
Standard Deviation .7
|
|
CURRENT Rib Fracture Pain in Previous 24 Hours
Month 0.5
|
3.5 score on a scale
Standard Deviation .7
|
1 score on a scale
Standard Deviation 0
|
|
CURRENT Rib Fracture Pain in Previous 24 Hours
Month 1
|
0 score on a scale
Standard Deviation 0
|
0 score on a scale
Standard Deviation 0
|
|
CURRENT Rib Fracture Pain in Previous 24 Hours
Month 1.5
|
0 score on a scale
Standard Deviation 0
|
0 score on a scale
Standard Deviation 0
|
|
CURRENT Rib Fracture Pain in Previous 24 Hours
Month 2
|
0 score on a scale
Standard Deviation 0
|
0 score on a scale
Standard Deviation 0
|
|
CURRENT Rib Fracture Pain in Previous 24 Hours
Month 3
|
0 score on a scale
Standard Deviation 0
|
0 score on a scale
Standard Deviation 0
|
|
CURRENT Rib Fracture Pain in Previous 24 Hours
Month 6
|
0 score on a scale
Standard Deviation 0
|
0 score on a scale
Standard Deviation 0
|
|
CURRENT Rib Fracture Pain in Previous 24 Hours
Month 12
|
0 score on a scale
Standard Deviation 0
|
0 score on a scale
Standard Deviation 0
|
|
CURRENT Rib Fracture Pain in Previous 24 Hours
Day 1
|
1.5 score on a scale
Standard Deviation 21
|
3.5 score on a scale
Standard Deviation 3.5
|
|
CURRENT Rib Fracture Pain in Previous 24 Hours
Day 2
|
5 score on a scale
Standard Deviation 0
|
4 score on a scale
Standard Deviation 2.8
|
SECONDARY outcome
Timeframe: Days 1, 2, and 7, and months 0.5, 1, 1.5, 2, 3, 6, 12 following procedureAmount of opioid used in last 24 hours (ultimately measured in morphine equivalents)
Outcome measures
| Measure |
Active Treatment
n=2 Participants
This group will receive a single injection nerve block of ropivacaine 0.5% (20 mL) followed by an infusion/boluses of ropivacaine 0.3% (continuous block)
Active ropivacaine 0.3% erector spinae plane perineural administration: Ropivacaine 0.3% administration via an erector spinae plane perineural catheter
|
Placebo
n=2 Participants
This group will receive a single injection nerve block of ropivacaine 0.5% (20 mL) followed by an infusion/boluses of normal saline
Placebo erector spinae plane perineural administration: Normal saline administration via an erector spinae plane perineural catheter
|
|---|---|---|
|
Opioid Consumption
Day 1
|
10 mg
Standard Deviation 0
|
2.5 mg
Standard Deviation 3.5
|
|
Opioid Consumption
Day 2
|
12.5 mg
Standard Deviation 10.6
|
5 mg
Standard Deviation 0
|
|
Opioid Consumption
Day 7
|
10 mg
Standard Deviation 7.1
|
2.5 mg
Standard Deviation 3.5
|
|
Opioid Consumption
Month 0.5
|
0 mg
Standard Deviation 0
|
0 mg
Standard Deviation 0
|
|
Opioid Consumption
Month 1
|
0 mg
Standard Deviation 0
|
0 mg
Standard Deviation 0
|
|
Opioid Consumption
Month 1.5
|
0 mg
Standard Deviation 0
|
0 mg
Standard Deviation 0
|
|
Opioid Consumption
Month 2
|
0 mg
Standard Deviation 0
|
0 mg
Standard Deviation 0
|
|
Opioid Consumption
Month 3
|
0 mg
Standard Deviation 0
|
0 mg
Standard Deviation 0
|
|
Opioid Consumption
Month 6
|
0 mg
Standard Deviation 0
|
0 mg
Standard Deviation 0
|
|
Opioid Consumption
Month 12
|
0 mg
Standard Deviation 0
|
0 mg
Standard Deviation 0
|
SECONDARY outcome
Timeframe: Days 1, 2, and 7, and months 0.5, 1, 1.5, 2, 3, 6, 12 following procedureNumber of awakenings due to rib fracture pain the previous night
Outcome measures
| Measure |
Active Treatment
n=2 Participants
This group will receive a single injection nerve block of ropivacaine 0.5% (20 mL) followed by an infusion/boluses of ropivacaine 0.3% (continuous block)
Active ropivacaine 0.3% erector spinae plane perineural administration: Ropivacaine 0.3% administration via an erector spinae plane perineural catheter
|
Placebo
n=2 Participants
This group will receive a single injection nerve block of ropivacaine 0.5% (20 mL) followed by an infusion/boluses of normal saline
Placebo erector spinae plane perineural administration: Normal saline administration via an erector spinae plane perineural catheter
|
|---|---|---|
|
Sleep Disturbances Due to Rib Fracture Pain
Day 1
|
0.5 awakenings
Standard Deviation 0.7
|
1.0 awakenings
Standard Deviation 1.4
|
|
Sleep Disturbances Due to Rib Fracture Pain
Day 2
|
1 awakenings
Standard Deviation 1.4
|
0.5 awakenings
Standard Deviation 0.7
|
|
Sleep Disturbances Due to Rib Fracture Pain
Day 7
|
.5 awakenings
Standard Deviation .7
|
1 awakenings
Standard Deviation 0
|
|
Sleep Disturbances Due to Rib Fracture Pain
Month 0.5
|
0 awakenings
Standard Deviation 0
|
1. awakenings
Standard Deviation 1.4
|
|
Sleep Disturbances Due to Rib Fracture Pain
Month 1
|
0 awakenings
Standard Deviation 0
|
0 awakenings
Standard Deviation 0
|
|
Sleep Disturbances Due to Rib Fracture Pain
Month 1.5
|
0 awakenings
Standard Deviation 0
|
0 awakenings
Standard Deviation 0
|
|
Sleep Disturbances Due to Rib Fracture Pain
Month 2
|
0 awakenings
Standard Deviation 0
|
0 awakenings
Standard Deviation 0
|
|
Sleep Disturbances Due to Rib Fracture Pain
Month 3
|
0 awakenings
Standard Deviation 0
|
0 awakenings
Standard Deviation 0
|
|
Sleep Disturbances Due to Rib Fracture Pain
Month 6
|
0 awakenings
Standard Deviation 0
|
0 awakenings
Standard Deviation 0
|
|
Sleep Disturbances Due to Rib Fracture Pain
Month 12
|
0 awakenings
Standard Deviation 0
|
0 awakenings
Standard Deviation 0
|
Adverse Events
Active Treatment
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo
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
Brian Ilfeld, MD, MS
University of California San Diego
Phone: (858) 822-0776
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place