Trial Outcomes & Findings for Effect of Sedation on Diagnostic Injections (NCT NCT01472835)
NCT ID: NCT01472835
Last Updated: 2016-12-15
Results Overview
pain diary using 0-10 scale, with 0 being no pain and 10 being the worst pain imaginable
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
73 participants
Primary outcome timeframe
through 6 hours after injection
Results posted on
2016-12-15
Participant Flow
Participant milestones
| Measure |
Sedation
Pt will receive sedation with their 1st procedure, then a control procedure will be done without sedation
sacroiliac joint injection: Patient will receive an injection into the sacroiliac joint with bupivacaine and corticosteroid with and without sedation. Since this is a crossover trial, patients will receive both "treatments".
Sympathetic block: Sympathetic block with bupivacaine
bupivacaine
corticosteroid
|
Control
Patient will not receive sedation during their 1st procedure, but receive sedation during the 2nd procedure
|
|---|---|---|
|
Overall Study
STARTED
|
37
|
36
|
|
Overall Study
COMPLETED
|
35
|
36
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
Reasons for withdrawal
| Measure |
Sedation
Pt will receive sedation with their 1st procedure, then a control procedure will be done without sedation
sacroiliac joint injection: Patient will receive an injection into the sacroiliac joint with bupivacaine and corticosteroid with and without sedation. Since this is a crossover trial, patients will receive both "treatments".
Sympathetic block: Sympathetic block with bupivacaine
bupivacaine
corticosteroid
|
Control
Patient will not receive sedation during their 1st procedure, but receive sedation during the 2nd procedure
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
0
|
Baseline Characteristics
Effect of Sedation on Diagnostic Injections
Baseline characteristics by cohort
| Measure |
Sedation
n=37 Participants
Pt will receive sedation with their 1st procedure and no sedation with their 2nd procedure
sacroiliac joint injection: Patient will receive an injection into the sacroiliac joint with bupivacaine and corticosteroid with and without sedation. Since this is a crossover trial, patients will receive both "treatments".
Sympathetic block: Sympathetic block with bupivacaine
bupivacaine
corticosteroid
|
Control
n=36 Participants
Patient will not receive no sedation during their 1st procedure and sedation during their 2nd procedure
|
Total
n=73 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
49.7 years
STANDARD_DEVIATION 16.1 • n=5 Participants
|
50.3 years
STANDARD_DEVIATION 13.8 • n=7 Participants
|
50.0 years
STANDARD_DEVIATION 15.0 • n=5 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
32 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
67 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
5 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Gender
Female
|
20 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
|
Gender
Male
|
17 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
37 participants
n=5 Participants
|
36 participants
n=7 Participants
|
73 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: through 6 hours after injectionpain diary using 0-10 scale, with 0 being no pain and 10 being the worst pain imaginable
Outcome measures
| Measure |
Sedation
n=36 Participants
Pt will receive sedation with their 1st procedure and no sedation with their 2nd procedure
sacroiliac joint injection: Patient will receive an injection into the sacroiliac joint with bupivacaine and corticosteroid with and without sedation. Since this is a crossover trial, patients will receive both "treatments".
Sympathetic block: Sympathetic block with bupivacaine
bupivacaine
corticosteroid
|
Control
n=36 Participants
Patient will not receive sedation during their 1st procedure but receive sedation during their 2nd procedure
|
|---|---|---|
|
Pain Score
|
2.2 units on a scale
Standard Deviation 2.3
|
3.4 units on a scale
Standard Deviation 2.8
|
SECONDARY outcome
Timeframe: 1-month0-10 numerical rating scale (NRS) pain scale. 0 being no pain and 10 being the worst possible pain.
Outcome measures
| Measure |
Sedation
n=36 Participants
Pt will receive sedation with their 1st procedure and no sedation with their 2nd procedure
sacroiliac joint injection: Patient will receive an injection into the sacroiliac joint with bupivacaine and corticosteroid with and without sedation. Since this is a crossover trial, patients will receive both "treatments".
Sympathetic block: Sympathetic block with bupivacaine
bupivacaine
corticosteroid
|
Control
n=36 Participants
Patient will not receive sedation during their 1st procedure but receive sedation during their 2nd procedure
|
|---|---|---|
|
Pain Score
|
5.1 units on a scale
Standard Deviation 2.9
|
5.6 units on a scale
Standard Deviation 2.8
|
SECONDARY outcome
Timeframe: 1 day0-10 pain scale, with 0 being no pain and 10 being the worst pain imaginable
Outcome measures
| Measure |
Sedation
n=36 Participants
Pt will receive sedation with their 1st procedure and no sedation with their 2nd procedure
sacroiliac joint injection: Patient will receive an injection into the sacroiliac joint with bupivacaine and corticosteroid with and without sedation. Since this is a crossover trial, patients will receive both "treatments".
Sympathetic block: Sympathetic block with bupivacaine
bupivacaine
corticosteroid
|
Control
n=36 Participants
Patient will not receive sedation during their 1st procedure but receive sedation during their 2nd procedure
|
|---|---|---|
|
Procedure-related Pain Score
|
3.1 units on a scale
Standard Deviation 2.8
|
5.5 units on a scale
Standard Deviation 2.7
|
SECONDARY outcome
Timeframe: 1-monthMeasure of functional capacity on a scale ranging from 0% to 100%, with 0% signifying no disability
Outcome measures
| Measure |
Sedation
n=36 Participants
Pt will receive sedation with their 1st procedure and no sedation with their 2nd procedure
sacroiliac joint injection: Patient will receive an injection into the sacroiliac joint with bupivacaine and corticosteroid with and without sedation. Since this is a crossover trial, patients will receive both "treatments".
Sympathetic block: Sympathetic block with bupivacaine
bupivacaine
corticosteroid
|
Control
n=36 Participants
Patient will not receive sedation during their 1st procedure but receive sedation during their 2nd procedure
|
|---|---|---|
|
Oswestry Disability Index
|
34.8 units on a scale
Standard Deviation 14.6
|
40.6 units on a scale
Standard Deviation 17.9
|
SECONDARY outcome
Timeframe: 1 day5-point Likert scale. The scale is from 1-5. 1 being very unsatisfied and 5 being very satisfied.
Outcome measures
| Measure |
Sedation
n=36 Participants
Pt will receive sedation with their 1st procedure and no sedation with their 2nd procedure
sacroiliac joint injection: Patient will receive an injection into the sacroiliac joint with bupivacaine and corticosteroid with and without sedation. Since this is a crossover trial, patients will receive both "treatments".
Sympathetic block: Sympathetic block with bupivacaine
bupivacaine
corticosteroid
|
Control
n=36 Participants
Patient will not receive sedation during their 1st procedure but receive sedation during their 2nd procedure
|
|---|---|---|
|
Satisfaction
|
4.0 units on a scale
Standard Deviation 1.1
|
3.6 units on a scale
Standard Deviation 1.4
|
Adverse Events
Sedation
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Control
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Sedation
n=37 participants at risk
Pt received sedation with their procedure
sacroiliac joint injection: Patient will receive an injection into the sacroiliac joint with bupivacaine and corticosteroid with and without sedation. Since this is a crossover trial, patients will receive both "treatments".
Sympathetic block: Sympathetic block with bupivacaine
bupivacaine
corticosteroid
|
Control
n=36 participants at risk
Patient did not receive sedation during procedure
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
2.7%
1/37 • Number of events 1 • 1 month
|
2.8%
1/36 • Number of events 1 • 1 month
|
|
Gastrointestinal disorders
dysphagia
|
2.7%
1/37 • Number of events 1 • 1 month
|
0.00%
0/36 • 1 month
|
|
Nervous system disorders
Headache
|
2.7%
1/37 • Number of events 1 • 1 month
|
2.8%
1/36 • Number of events 1 • 1 month
|
|
Musculoskeletal and connective tissue disorders
Worse pain
|
0.00%
0/37 • 1 month
|
5.6%
2/36 • Number of events 2 • 1 month
|
|
Nervous system disorders
Weakness
|
0.00%
0/37 • 1 month
|
2.8%
1/36 • Number of events 1 • 1 month
|
|
General disorders
Dizziness
|
0.00%
0/37 • 1 month
|
2.8%
1/36 • Number of events 1 • 1 month
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place