Trial Outcomes & Findings for Effect of Local Anaesthetic Volume on Axillary Brachial Plexus Block Duration (NCT NCT03163472)
NCT ID: NCT03163472
Last Updated: 2021-10-04
Results Overview
Duration of sensory block of ultrasound guided brachial plexus block
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
30 participants
Primary outcome timeframe
24 hours
Results posted on
2021-10-04
Participant Flow
Assessed for eligibility: n= 60 Excluded : n=30 * Not meeting inclusion criteria: n = 5 * Declined to participate: n= 25
Participant milestones
| Measure |
10ml of Lidocaine 2% With Epinephrine
patients will receive axillary brachial plexus block with 10 ml of lidocaine 2% with epinephrine.
Axillary brachial plexus block: patients will receive axillary brachial plexus block with 10 ml of lidocaine 2% with epinephrine.
|
30ml of Lidocaine 2% With Epinephrine
patients will receive axillary brachial plexus block with 30 ml of lidocaine 2% with epinephrine.
Axillary brachial plexus block: patients will receive axillary brachial plexus block with 30 ml of lidocaine 2% with epinephrine.
|
|---|---|---|
|
Overall Study
STARTED
|
15
|
15
|
|
Overall Study
COMPLETED
|
15
|
15
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effect of Local Anaesthetic Volume on Axillary Brachial Plexus Block Duration
Baseline characteristics by cohort
| Measure |
10 ml of Lidocaine 2% With Epinephrine
n=15 Participants
patients will receive axillary brachial plexus block with 10 ml of lidocaine 2% with epinephrine.
Axillary brachial plexus block: patients will receive axillary brachial plexus block with 10 ml of lidocaine 2% with epinephrine.
|
30ml of Lidocaine 2% With Epinephrine
n=15 Participants
patients will receive axillary brachial plexus block with 30 ml of lidocaine 2% with epinephrine.
Axillary brachial plexus block: patients will receive axillary brachial plexus block with 30 ml of lidocaine 2% with epinephrine.
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
49 years
STANDARD_DEVIATION 15.1 • n=99 Participants
|
50 years
STANDARD_DEVIATION 22.1 • n=107 Participants
|
49.3 years
STANDARD_DEVIATION 18.6 • n=206 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
17 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 24 hoursDuration of sensory block of ultrasound guided brachial plexus block
Outcome measures
| Measure |
10 ml of Lidocaine 2% With Epinephrine
n=15 Participants
patients will receive axillary brachial plexus block with 10 ml of lidocaine 2% with epinephrine.
Axillary brachial plexus block with 10 mL oof local anaesthetic: patients will receive axillary brachial plexus block with 10 ml of lidocaine 2% with epinephrine.
|
30ml of Lidocaine 2% With Epinephrine
n=15 Participants
patients will receive axillary brachial plexus block with 30 ml of lidocaine 2% with epinephrine.
Axillary brachial plexus block with 30 ml of local anaesthetic: patients will receive axillary brachial plexus block with 30 ml of lidocaine 2% with epinephrine.
|
|---|---|---|
|
Overall Duration of Sensory Block.
|
165 minutes
Interval 142.0 to 172.0
|
188 minutes
Interval 173.0 to 205.0
|
SECONDARY outcome
Timeframe: 24 hoursThe total duration of motor block
Outcome measures
| Measure |
10 ml of Lidocaine 2% With Epinephrine
n=15 Participants
patients will receive axillary brachial plexus block with 10 ml of lidocaine 2% with epinephrine.
Axillary brachial plexus block with 10 mL oof local anaesthetic: patients will receive axillary brachial plexus block with 10 ml of lidocaine 2% with epinephrine.
|
30ml of Lidocaine 2% With Epinephrine
n=15 Participants
patients will receive axillary brachial plexus block with 30 ml of lidocaine 2% with epinephrine.
Axillary brachial plexus block with 30 ml of local anaesthetic: patients will receive axillary brachial plexus block with 30 ml of lidocaine 2% with epinephrine.
|
|---|---|---|
|
Duration of Motor Block
|
165 minutes
Interval 147.0 to 180.0
|
195 minutes
Interval 175.0 to 220.0
|
SECONDARY outcome
Timeframe: 6 hoursTime to overall onset time for block
Outcome measures
| Measure |
10 ml of Lidocaine 2% With Epinephrine
n=15 Participants
patients will receive axillary brachial plexus block with 10 ml of lidocaine 2% with epinephrine.
Axillary brachial plexus block with 10 mL oof local anaesthetic: patients will receive axillary brachial plexus block with 10 ml of lidocaine 2% with epinephrine.
|
30ml of Lidocaine 2% With Epinephrine
n=15 Participants
patients will receive axillary brachial plexus block with 30 ml of lidocaine 2% with epinephrine.
Axillary brachial plexus block with 30 ml of local anaesthetic: patients will receive axillary brachial plexus block with 30 ml of lidocaine 2% with epinephrine.
|
|---|---|---|
|
Time to Onset of the Block
|
15 minutes
Interval 10.0 to 15.0
|
10 minutes
Interval 5.0 to 15.0
|
SECONDARY outcome
Timeframe: 24 hoursPost-operative, Time to first request of opioid analgesia by the participants
Outcome measures
| Measure |
10 ml of Lidocaine 2% With Epinephrine
n=15 Participants
patients will receive axillary brachial plexus block with 10 ml of lidocaine 2% with epinephrine.
Axillary brachial plexus block with 10 mL oof local anaesthetic: patients will receive axillary brachial plexus block with 10 ml of lidocaine 2% with epinephrine.
|
30ml of Lidocaine 2% With Epinephrine
n=15 Participants
patients will receive axillary brachial plexus block with 30 ml of lidocaine 2% with epinephrine.
Axillary brachial plexus block with 30 ml of local anaesthetic: patients will receive axillary brachial plexus block with 30 ml of lidocaine 2% with epinephrine.
|
|---|---|---|
|
Time to First Request of Postoperative Opioid Analgesia
|
188 minutes
Interval 168.0 to 224.0
|
267 minutes
Interval 224.0 to 313.0
|
SECONDARY outcome
Timeframe: 24 hoursoverall cumulative opioid consumption dose of the participants
Outcome measures
| Measure |
10 ml of Lidocaine 2% With Epinephrine
n=15 Participants
patients will receive axillary brachial plexus block with 10 ml of lidocaine 2% with epinephrine.
Axillary brachial plexus block with 10 mL oof local anaesthetic: patients will receive axillary brachial plexus block with 10 ml of lidocaine 2% with epinephrine.
|
30ml of Lidocaine 2% With Epinephrine
n=15 Participants
patients will receive axillary brachial plexus block with 30 ml of lidocaine 2% with epinephrine.
Axillary brachial plexus block with 30 ml of local anaesthetic: patients will receive axillary brachial plexus block with 30 ml of lidocaine 2% with epinephrine.
|
|---|---|---|
|
Opioid Consumption
|
8.3 mg
Standard Deviation 5.6
|
6.3 mg
Standard Deviation 6.9
|
SECONDARY outcome
Timeframe: 24 hoursPopulation: No adverse events noted in any participants in either group
We recorded the the number of participants with adverse effects like nausea, dizziness, tinnitus, vomiting, convulsions or arrhythmia during the perioperative period.
Outcome measures
| Measure |
10 ml of Lidocaine 2% With Epinephrine
n=15 Participants
patients will receive axillary brachial plexus block with 10 ml of lidocaine 2% with epinephrine.
Axillary brachial plexus block with 10 mL oof local anaesthetic: patients will receive axillary brachial plexus block with 10 ml of lidocaine 2% with epinephrine.
|
30ml of Lidocaine 2% With Epinephrine
n=15 Participants
patients will receive axillary brachial plexus block with 30 ml of lidocaine 2% with epinephrine.
Axillary brachial plexus block with 30 ml of local anaesthetic: patients will receive axillary brachial plexus block with 30 ml of lidocaine 2% with epinephrine.
|
|---|---|---|
|
Number of Participants With Adverse Effects Perioperatively: Nausea, Dizziness, Tinnitus, Vomiting, Convulsions or Arrhythmia"
|
0 Participants
|
0 Participants
|
Adverse Events
10ml of Lidocaine 2% With Epinephrine
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
30ml of Lidocaine 2% With Epinephrine
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