Trial Outcomes & Findings for Needle-Guided vs Free-Hand Technique in Performing Brachial Plexus Blockade (NCT NCT02380183)
NCT ID: NCT02380183
Last Updated: 2019-03-12
Results Overview
needle insertion to needle withdrawal
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
70 participants
Primary outcome timeframe
Needle insertion to needle withdrawal, up to 20 minutes
Results posted on
2019-03-12
Participant Flow
Participant milestones
| Measure |
Intervention
Civco needle guidance device will be used while the nerve block is performed.
Civco Needle Guidance Device: Needle guidance device will be used while nerve block is performed.
|
Standard of Care
Needle guidance device will not be used while nerve block is performed; nerve block is performed by hand alone.
|
|---|---|---|
|
Overall Study
STARTED
|
36
|
34
|
|
Overall Study
COMPLETED
|
36
|
34
|
|
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 |
Intervention
n=36 Participants
Civco needle guidance device will be used while the nerve block is performed.
Civco Needle Guidance Device: Needle guidance device will be used while nerve block is performed.
|
Standard of Care
n=34 Participants
Needle guidance device will not be used while nerve block is performed; nerve block is performed by hand alone.
|
Total
n=70 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
56 years
n=36 Participants
|
50 years
n=34 Participants
|
53 years
n=70 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=36 Participants
|
20 Participants
n=34 Participants
|
38 Participants
n=70 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=36 Participants
|
14 Participants
n=34 Participants
|
32 Participants
n=70 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
36 Participants
n=36 Participants
|
34 Participants
n=34 Participants
|
70 Participants
n=70 Participants
|
PRIMARY outcome
Timeframe: Needle insertion to needle withdrawal, up to 20 minutesneedle insertion to needle withdrawal
Outcome measures
| Measure |
Intervention
n=36 Participants
Civco needle guidance device will be used while the nerve block is performed.
Civco Needle Guidance Device: Needle guidance device will be used while nerve block is performed.
|
Standard of Care
n=34 Participants
Needle guidance device will not be used while nerve block is performed; nerve block is performed by hand alone.
|
|---|---|---|
|
Needle Time;
|
106 seconds
Interval 92.0 to 162.0
|
197 seconds
Interval 140.0 to 278.0
|
SECONDARY outcome
Timeframe: time from ultrasound contact with skin to needle withdrawal, up to 20 minutesHow long the procedure takes in minutes, starting from ultrasound contact with skin to needle withdrawal.
Outcome measures
| Measure |
Intervention
n=36 Participants
Civco needle guidance device will be used while the nerve block is performed.
Civco Needle Guidance Device: Needle guidance device will be used while nerve block is performed.
|
Standard of Care
n=34 Participants
Needle guidance device will not be used while nerve block is performed; nerve block is performed by hand alone.
|
|---|---|---|
|
Nerve Block Procedure Time
|
86 seconds
Interval 76.0 to 146.0
|
126 seconds
Interval 94.0 to 126.0
|
Adverse Events
Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Standard of Care
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