Trial Outcomes & Findings for Duration of Analgesic Effect for Ultrasound Guided Supraclavicular Blocks With the Addition of Buprenorphine to Local Anesthetic Solution (NCT NCT01583179)
NCT ID: NCT01583179
Last Updated: 2019-09-11
Results Overview
Time in minutes until first pain medication was take by participant post-operatively
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
26 participants
Primary outcome timeframe
48 hrs
Results posted on
2019-09-11
Participant Flow
Participant milestones
| Measure |
Control Group
will get only local anesthetic and epinephrine in block. no additive in block
|
Buprenorphine
will receive local anesthetic, epinephrine and the additive buprenorphine to nerve block
Buprenorphine: added to nerve block, 0.3mg one time peripheral block use
|
|---|---|---|
|
Overall Study
STARTED
|
14
|
12
|
|
Overall Study
COMPLETED
|
13
|
10
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
Reasons for withdrawal
| Measure |
Control Group
will get only local anesthetic and epinephrine in block. no additive in block
|
Buprenorphine
will receive local anesthetic, epinephrine and the additive buprenorphine to nerve block
Buprenorphine: added to nerve block, 0.3mg one time peripheral block use
|
|---|---|---|
|
Overall Study
Screen failure
|
1
|
2
|
Baseline Characteristics
Duration of Analgesic Effect for Ultrasound Guided Supraclavicular Blocks With the Addition of Buprenorphine to Local Anesthetic Solution
Baseline characteristics by cohort
| Measure |
Control Group
n=14 Participants
will get only local anesthetic and epinephrine in block. no additive in block
|
Buprenorphine
n=12 Participants
will receive local anesthetic, epinephrine and the additive buprenorphine to nerve block
Buprenorphine: added to nerve block, 0.3mg one time peripheral block use
|
Total
n=26 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
Age of participants · 20-29
|
3 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
|
Age, Customized
Age of participants · 30-39
|
0 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Age, Customized
Age of participants · 40-49
|
4 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
|
Age, Customized
Age of participants · 50-59
|
3 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
|
Age, Customized
Age of participants · 60-69
|
3 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
|
Age, Customized
Age of participants · 70-79
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=93 Participants
|
6 Participants
n=4 Participants
|
14 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=93 Participants
|
6 Participants
n=4 Participants
|
12 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
12 Participants
n=93 Participants
|
11 Participants
n=4 Participants
|
23 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
11 Participants
n=93 Participants
|
11 Participants
n=4 Participants
|
22 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: 48 hrsPopulation: The study was closed prematurely due to low enrollment and anticipation of future barriers in enrollment.The Overall Number of Participants Analyzed represents the Number of Participants with evaluable data.
Time in minutes until first pain medication was take by participant post-operatively
Outcome measures
| Measure |
Control Group
n=9 Participants
will get only local anesthetic and epinephrine in block. no additive in block
|
Buprenorphine
n=10 Participants
will receive local anesthetic, epinephrine and the additive buprenorphine to nerve block
Buprenorphine: added to nerve block, 0.3mg one time peripheral block use
|
|---|---|---|
|
Time Until First Pain Medication Post-operatively
|
965 Time in minutes
Standard Deviation 250
|
862 Time in minutes
Standard Deviation 311
|
SECONDARY outcome
Timeframe: 1 day postoperativePopulation: The study was closed prematurely due to low enrollment and anticipation of future barriers in enrollment
pain score on post operative day 1 was measured on a scale 1-10. higher scores correlates with more severe pain. score range is from '0' (no pain) to 10 (pain as severe as it can be)
Outcome measures
| Measure |
Control Group
n=10 Participants
will get only local anesthetic and epinephrine in block. no additive in block
|
Buprenorphine
n=12 Participants
will receive local anesthetic, epinephrine and the additive buprenorphine to nerve block
Buprenorphine: added to nerve block, 0.3mg one time peripheral block use
|
|---|---|---|
|
Pain Score on Post Operative Day 1
|
6.5 score on a scale
Interval 4.25 to 7.75
|
4.5 score on a scale
Interval 1.75 to 8.25
|
Adverse Events
Control Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Buprenorphine
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