Trial Outcomes & Findings for Analgesic Efficacy of Perineural Dexamethasone During Supraclavicular Block for Hand Surgery (NCT NCT02154048)
NCT ID: NCT02154048
Last Updated: 2014-09-11
Results Overview
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
5 participants
Primary outcome timeframe
48 hours
Results posted on
2014-09-11
Participant Flow
Because the required sample size of 60 subjects was not met, the study was terminated. Five subjects were enrolled from April 2012 to September 2013.
Participant milestones
| Measure |
Intravenous (IV) Control Group
This group will be comprised of 20 subjects who will receive an ultrasound-guided supraclavicular brachial plexus block with 30ml of ropivacaine 0.5% with 1:400,000 epinephrine and an IV preservative-free dexamethasone 8 mg injection.
Ropivacaine + Dexamethasone
|
Local Anesthetic (LA) Control Group
This group will be comprised of 20 subjects who will receive an ultrasound-guided supraclavicular brachial plexus block with 30ml of ropivacaine 0.5% with 1:400,000 epinephrine and an intravenous (IV) normal saline placebo injection.
Ropivacaine + Placebo
|
Additive Group
This group will be comprised of 20 subjects who will receive an ultrasound-guided supraclavicular brachial plexus block with 30ml of ropivacaine 0.5% with both 1:400,000 epinephrine and preservative-free dexamethasone 8mg and an IV normal saline placebo injection.
Ropivacaine + Dexamethasone + Placebo
|
|---|---|---|---|
|
Overall Study
STARTED
|
2
|
2
|
1
|
|
Overall Study
COMPLETED
|
2
|
2
|
1
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Analgesic Efficacy of Perineural Dexamethasone During Supraclavicular Block for Hand Surgery
Baseline characteristics by cohort
| Measure |
Intravenous (IV) Control Group
n=2 Participants
This group will be comprised of 20 subjects who will receive an ultrasound-guided supraclavicular brachial plexus block with 30ml of ropivacaine 0.5% with 1:400,000 epinephrine and an IV preservative-free dexamethasone 8 mg injection.
Ropivacaine + Dexamethasone
|
Local Anesthetic (LA) Control Group
n=2 Participants
This group will be comprised of 20 subjects who will receive an ultrasound-guided supraclavicular brachial plexus block with 30ml of ropivacaine 0.5% with 1:400,000 epinephrine and an intravenous (IV) normal saline placebo injection.
Ropivacaine + Placebo
|
Additive Group
n=1 Participants
This group will be comprised of 20 subjects who will receive an ultrasound-guided supraclavicular brachial plexus block with 30ml of ropivacaine 0.5% with both 1:400,000 epinephrine and preservative-free dexamethasone 8mg and an IV normal saline placebo injection.
Ropivacaine + Dexamethasone + Placebo
|
Total
n=5 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Customized
>= 18 years
|
2 participants
n=5 Participants
|
2 participants
n=7 Participants
|
1 participants
n=5 Participants
|
5 participants
n=4 Participants
|
|
Age, Customized
<=17 years
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 48 hoursPopulation: one subject in the Local Anesthetic (LA) Control Group was not analyzed because subject did not return the data sheet
Outcome measures
| Measure |
Local Anesthetic (LA) Control Group
n=1 Participants
This group will be comprised of 20 subjects who will receive an ultrasound-guided supraclavicular brachial plexus block with 30ml of ropivacaine 0.5% with 1:400,000 epinephrine and an intravenous (IV) normal saline placebo injection.
Ropivacaine + Placebo
|
Intravenous (IV) Control Group
n=2 Participants
This group will be comprised of 20 subjects who will receive an ultrasound-guided supraclavicular brachial plexus block with 30ml of ropivacaine 0.5% with 1:400,000 epinephrine and an IV preservative-free dexamethasone 8 mg injection.
Ropivacaine + Dexamethasone
|
Additive Group
n=1 Participants
This group will be comprised of 20 subjects who will receive an ultrasound-guided supraclavicular brachial plexus block with 30ml of ropivacaine 0.5% with both 1:400,000 epinephrine and preservative-free dexamethasone 8mg and an IV normal saline placebo injection.
Ropivacaine + Dexamethasone + Placebo
|
|---|---|---|---|
|
Time to First Analgesic Dose
|
10 hours
Standard Deviation 0
|
6 hours
Standard Deviation 0
|
4 hours
Standard Deviation 0
|
Adverse Events
Intravenous (IV) Control Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Local Anesthetic (LA) Control Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Additive Group
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