Trial Outcomes & Findings for Cosyntropin Versus Epidural Blood Patch (EBP) for Treatment of Treatment of Post Dural Puncture Headache (NCT NCT02394457)
NCT ID: NCT02394457
Last Updated: 2016-11-01
Results Overview
Numerical 0-10 (0 no pain, 10 worst pain)
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
29 participants
Primary outcome timeframe
1 day post procedure
Results posted on
2016-11-01
Participant Flow
29 were consented, of these 28 patients met study criteria and were randomized
Participant milestones
| Measure |
Intravenous Cosyntropin Group A
Cosyntropin 500 mcg in 1000cc Normal Saline
Cosyntropin: Intravenous Drug Infusion over 1 hour and a half
|
Epidural Blood Patch Group B
Epidural Blood Patch and I000cc Normal Saline
Epidural Blood Patch: Blood drawn from subject and then same Blood placed into Epidural space by anesthesia personnel.
|
|---|---|---|
|
Overall Study
STARTED
|
15
|
13
|
|
Overall Study
COMPLETED
|
15
|
13
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Cosyntropin Versus Epidural Blood Patch (EBP) for Treatment of Treatment of Post Dural Puncture Headache
Baseline characteristics by cohort
| Measure |
Intravenous Cosyntropin Group A
n=15 Participants
Cosyntropin 500 mcg in 1000cc Normal Saline
Cosyntropin: Intravenous Drug Infusion over 1 hour and a half
|
Epidural Blood Patch Group B
n=13 Participants
Epidural Blood Patch and I000cc Normal Saline
Epidural Blood Patch: Blood drawn from subject and then same Blood placed into Epidural space by anesthesia personnel.
|
Total
n=28 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
29.2 years
n=5 Participants
|
26.9 years
n=7 Participants
|
28.05 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Pain
|
8.53 units on a scale
n=5 Participants
|
8.50 units on a scale
n=7 Participants
|
17.03 units on a scale
n=5 Participants
|
|
Function
|
7.4 units on a scale
n=5 Participants
|
7.17 units on a scale
n=7 Participants
|
7.29 units on a scale
n=5 Participants
|
|
Positional Headache
|
14 participants
n=5 Participants
|
11 participants
n=7 Participants
|
25 participants
n=5 Participants
|
|
Nausea/Vomiting
|
10 participants
n=5 Participants
|
11 participants
n=7 Participants
|
21 participants
n=5 Participants
|
|
Neck Stiffness
|
10 participants
n=5 Participants
|
10 participants
n=7 Participants
|
20 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 day post procedureNumerical 0-10 (0 no pain, 10 worst pain)
Outcome measures
| Measure |
Intravenous Cosyntropin Group A
n=15 Participants
Cosyntropin 500 mcg in 1000cc Normal Saline
Cosyntropin: Intravenous Drug Infusion over 1 hour and a half
|
Epidural Blood Patch Group B
n=13 Participants
Epidural Blood Patch and I000cc Normal Saline
Epidural Blood Patch: Blood drawn from subject and then same Blood placed into Epidural space by anesthesia personnel.
|
|---|---|---|
|
Headache Pain Score
|
6.67 units on a scale
Standard Deviation 7.56
|
2.33 units on a scale
Standard Deviation 2.74
|
PRIMARY outcome
Timeframe: 3 days post procedureNumerical 0-10 (0 no pain, 10 worst pain)
Outcome measures
| Measure |
Intravenous Cosyntropin Group A
n=15 Participants
Cosyntropin 500 mcg in 1000cc Normal Saline
Cosyntropin: Intravenous Drug Infusion over 1 hour and a half
|
Epidural Blood Patch Group B
n=13 Participants
Epidural Blood Patch and I000cc Normal Saline
Epidural Blood Patch: Blood drawn from subject and then same Blood placed into Epidural space by anesthesia personnel.
|
|---|---|---|
|
Headache Pain Score
|
3.13 units on a scale
Standard Deviation 2.01
|
2.36 units on a scale
Standard Deviation 2.47
|
PRIMARY outcome
Timeframe: 7 days post procedureNumerical 0-10 (0 no pain, 10 worst pain)
Outcome measures
| Measure |
Intravenous Cosyntropin Group A
n=15 Participants
Cosyntropin 500 mcg in 1000cc Normal Saline
Cosyntropin: Intravenous Drug Infusion over 1 hour and a half
|
Epidural Blood Patch Group B
n=13 Participants
Epidural Blood Patch and I000cc Normal Saline
Epidural Blood Patch: Blood drawn from subject and then same Blood placed into Epidural space by anesthesia personnel.
|
|---|---|---|
|
Headache Pain Score
|
1.93 units on a scale
Standard Deviation 1.84
|
1.82 units on a scale
Standard Deviation 1.86
|
SECONDARY outcome
Timeframe: 1 day post procedureFunctional score 0-10 (0 being able to function all tasks of daily living, 10 not able to complete activities of daily living (ADLs)
Outcome measures
| Measure |
Intravenous Cosyntropin Group A
n=15 Participants
Cosyntropin 500 mcg in 1000cc Normal Saline
Cosyntropin: Intravenous Drug Infusion over 1 hour and a half
|
Epidural Blood Patch Group B
n=13 Participants
Epidural Blood Patch and I000cc Normal Saline
Epidural Blood Patch: Blood drawn from subject and then same Blood placed into Epidural space by anesthesia personnel.
|
|---|---|---|
|
Functioning Score
|
6.53 units on a scale
Standard Deviation 1.35
|
2.00 units on a scale
Standard Deviation 2.83
|
SECONDARY outcome
Timeframe: 3 day post procedureFunctional score 0-10 (0 being able to function all tasks of daily living, 10 not able to complete ADLs
Outcome measures
| Measure |
Intravenous Cosyntropin Group A
n=15 Participants
Cosyntropin 500 mcg in 1000cc Normal Saline
Cosyntropin: Intravenous Drug Infusion over 1 hour and a half
|
Epidural Blood Patch Group B
n=13 Participants
Epidural Blood Patch and I000cc Normal Saline
Epidural Blood Patch: Blood drawn from subject and then same Blood placed into Epidural space by anesthesia personnel.
|
|---|---|---|
|
Functioning Score
|
3.20 units on a scale
Standard Deviation 1.81
|
2.09 units on a scale
Standard Deviation 2.34
|
SECONDARY outcome
Timeframe: 7 day post procedureFunctional score 0-10 (0 being able to function all tasks of daily living, 10 not able to complete ADLs
Outcome measures
| Measure |
Intravenous Cosyntropin Group A
n=15 Participants
Cosyntropin 500 mcg in 1000cc Normal Saline
Cosyntropin: Intravenous Drug Infusion over 1 hour and a half
|
Epidural Blood Patch Group B
n=13 Participants
Epidural Blood Patch and I000cc Normal Saline
Epidural Blood Patch: Blood drawn from subject and then same Blood placed into Epidural space by anesthesia personnel.
|
|---|---|---|
|
Functioning Score
|
2.14 units on a scale
Standard Deviation 1.03
|
1.64 units on a scale
Standard Deviation 2.35
|
Adverse Events
Intravenous Cosyntropin Group A
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Epidural Blood Patch Group B
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place