Trial Outcomes & Findings for Comparison Between Epinephrine and Clonidine as Adjuvants to Lidocaine in Axillary Brachial Plexus Block. (NCT NCT03207022)
NCT ID: NCT03207022
Last Updated: 2021-09-02
Results Overview
Time taken for onset of sensory axillary brachial plexus block
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
24 participants
Primary outcome timeframe
1 day
Results posted on
2021-09-02
Participant Flow
Assessed for eligibility: n = 50 Excluded 26 * Not meeting inclusion criteria n= 8 * Declined to participate n= 18 Randomized n = 24
Participant milestones
| Measure |
Lidocaine 2% With Normal Saline
Patients will receive ultrasound guided axillary brachial plexus block with 20 ml of lidocaine 2% with epinephrine mixed with 2 ml of 0.9% normal saline.
axillary brachial plexus block: ultrasound guided axillary brachial plexus block with 20 ml local anaesthetic lidocaine with epinephrine and clonidine
|
Lidocaine 2% With Clonidine
Patients will receive ultrasound guided axillary brachial plexus block with 20 ml of lidocaine 2% with epinephrine mixed with clonidine 1µg/kg in 2 ml of 0.9% normal saline.
axillary brachial plexus block: ultrasound guided axillary brachial plexus block with 20 ml local anaesthetic lidocaine with epinephrine and clonidine
|
|---|---|---|
|
Overall Study
STARTED
|
12
|
12
|
|
Overall Study
COMPLETED
|
12
|
12
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Comparison Between Epinephrine and Clonidine as Adjuvants to Lidocaine in Axillary Brachial Plexus Block.
Baseline characteristics by cohort
| Measure |
Lidocaine 2% With Normal Saline
n=12 Participants
Patients will receive ultrasound guided axillary brachial plexus block with 20 ml of lidocaine 2% with epinephrine mixed with 2 ml of 0.9% normal saline.
axillary brachial plexus block: ultrasound guided axillary brachial plexus block with 20 ml local anaesthetic lidocaine with epinephrine and clonidine
|
Lidocaine 2% With Clonidine
n=12 Participants
Patients will receive ultrasound guided axillary brachial plexus block with 20 ml of lidocaine 2% with epinephrine mixed with clonidine 1µg/kg in 2 ml of 0.9% normal saline.
axillary brachial plexus block: ultrasound guided axillary brachial plexus block with 20 ml local anaesthetic lidocaine with epinephrine and clonidine
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
41.4 years
STANDARD_DEVIATION 10.6 • n=5 Participants
|
42.3 years
STANDARD_DEVIATION 8.6 • n=7 Participants
|
41.9 years
STANDARD_DEVIATION 9.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Region of Enrollment
Ireland
|
12 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 dayTime taken for onset of sensory axillary brachial plexus block
Outcome measures
| Measure |
Lidocaine 2% With Normal Saline
n=12 Participants
Patients will receive ultrasound guided axillary brachial plexus block with 20 ml of lidocaine 2% with epinephrine mixed with 2 ml of 0.9% normal saline.
axillary brachial plexus block: ultrasound guided axillary brachial plexus block with 20 ml local anaesthetic lidocaine with epinephrine and clonidine
|
Lidocaine 2% With Clonidine
n=12 Participants
Patients will receive ultrasound guided axillary brachial plexus block with 20 ml of lidocaine 2% with epinephrine mixed with clonidine 1µg/kg in 2 ml of 0.9% normal saline.
axillary brachial plexus block: ultrasound guided axillary brachial plexus block with 20 ml local anaesthetic lidocaine with epinephrine and clonidine
|
|---|---|---|
|
Onset of Sensory Block
|
10 minutes
Interval 8.8 to 12.5
|
5 minutes
Interval 5.0 to 7.5
|
SECONDARY outcome
Timeframe: 1 daytime taken for onset of motor block of ultrasound guided axillary brachial plexus block
Outcome measures
| Measure |
Lidocaine 2% With Normal Saline
n=12 Participants
Patients will receive ultrasound guided axillary brachial plexus block with 20 ml of lidocaine 2% with epinephrine mixed with 2 ml of 0.9% normal saline.
axillary brachial plexus block: ultrasound guided axillary brachial plexus block with 20 ml local anaesthetic lidocaine with epinephrine and clonidine
|
Lidocaine 2% With Clonidine
n=12 Participants
Patients will receive ultrasound guided axillary brachial plexus block with 20 ml of lidocaine 2% with epinephrine mixed with clonidine 1µg/kg in 2 ml of 0.9% normal saline.
axillary brachial plexus block: ultrasound guided axillary brachial plexus block with 20 ml local anaesthetic lidocaine with epinephrine and clonidine
|
|---|---|---|
|
Onset of Motor Block.
|
7.5 minutes
Interval 6.3 to 7.5
|
5 minutes
Interval 2.5 to 7.5
|
SECONDARY outcome
Timeframe: 1 dayTotal duration of sensory block of ultrasound guided axillary brachial plexus block
Outcome measures
| Measure |
Lidocaine 2% With Normal Saline
n=12 Participants
Patients will receive ultrasound guided axillary brachial plexus block with 20 ml of lidocaine 2% with epinephrine mixed with 2 ml of 0.9% normal saline.
axillary brachial plexus block: ultrasound guided axillary brachial plexus block with 20 ml local anaesthetic lidocaine with epinephrine and clonidine
|
Lidocaine 2% With Clonidine
n=12 Participants
Patients will receive ultrasound guided axillary brachial plexus block with 20 ml of lidocaine 2% with epinephrine mixed with clonidine 1µg/kg in 2 ml of 0.9% normal saline.
axillary brachial plexus block: ultrasound guided axillary brachial plexus block with 20 ml local anaesthetic lidocaine with epinephrine and clonidine
|
|---|---|---|
|
Duration of Sensory and Motor Block
|
165 minutes
Standard Deviation 24.1
|
218.3 minutes
Standard Deviation 28.5
|
Adverse Events
Lidocaine 2% With Normal Saline
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Lidocaine 2% With Clonidine
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