Trial Outcomes & Findings for Control of Tourniquet Pain With an Axillary Ring of Subcutaneous Local Anesthetic (NCT NCT01829399)
NCT ID: NCT01829399
Last Updated: 2015-10-22
Results Overview
15 minutes after either Bupivacaine or placebo injection, Tq was inflated to 100 mm Hg over subjects systolic blood pressure. When the subject found the Tq too uncomfortable, the Tq was deflated and the time documented. Approximately one month later, each subject had the opposite injection of either placebo or Bupivacaine on the same arm, and the duration of Tq inflation was again measured. Due to a strong crossover effect, only the data assessed from the first intervention was analyzed.
COMPLETED
PHASE4
24 participants
Tq was inflated 15 minutes after injection of Bupivacaine or placebo and remained inflated until subject could no longer tolerate it. Maximum allowable inflation time per session was 60 minutes.
2015-10-22
Participant Flow
Participant milestones
| Measure |
Bupivacaine Ring 1st Visit, Saline Ring 2nd Visit
Participants received a subcutaneous axillary ring injection with 0.25% Bupivacaine with epinephrine 1:200.000 on the first visit and a subcutaneous axillary ring injection with saline on the second visit.
|
Saline Ring 1st Visit, Bupivacaine Ring 2nd Visit
Participants received a subcutaneous axillary ring injection with normal saline on the first visit and a subcutaneous axillary ring injection with 0.25% Bupivacaine with epinephrine 1:200.000 on the second visit.
|
|---|---|---|
|
Visit 1
STARTED
|
12
|
12
|
|
Visit 1
COMPLETED
|
12
|
12
|
|
Visit 1
NOT COMPLETED
|
0
|
0
|
|
Visit 2 (One Month Later)
STARTED
|
12
|
12
|
|
Visit 2 (One Month Later)
COMPLETED
|
12
|
12
|
|
Visit 2 (One Month Later)
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Control of Tourniquet Pain With an Axillary Ring of Subcutaneous Local Anesthetic
Baseline characteristics by cohort
| Measure |
Bupivacaine Ring 1st Visit, Saline Ring 2nd Visit
n=12 Participants
On the first visit, subcutaneous axillary ring of 10 to 15 ml of 0.25% Bupivacaine with epinephrine 1:200,000 was injected 15 minutes prior to tourniquet inflation. On the second visit, a subcutaneous axillary ring of 10 to 15 ml of saline was injected 15 minutes prior to tourniquet inflation.
|
Saline Ring 1st Visit, Bupivacaine Ring 2nd Visit
n=12 Participants
On the first visit, a subcutaneous axillary ring of 10 to 15 mL of normal saline was injected 15 minutes prior to tourniquet inflation. On the second visit, a subcutaneous axillary ring of 10 to 15 ml of 0.25% Bupivacaine with epinephrine 1:200,000 was injected 15 minutes prior to tourniquet inflation.
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
12 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
24 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Continuous
|
31.7 years
STANDARD_DEVIATION 10.0 • n=99 Participants
|
32.3 years
STANDARD_DEVIATION 10.5 • n=107 Participants
|
32.0 years
STANDARD_DEVIATION 10.3 • n=206 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
12 participants
n=99 Participants
|
12 participants
n=107 Participants
|
24 participants
n=206 Participants
|
|
Arm Dominance
Dominant Arm
|
6 participants
n=99 Participants
|
6 participants
n=107 Participants
|
12 participants
n=206 Participants
|
|
Arm Dominance
Non-Dominant Arm
|
6 participants
n=99 Participants
|
6 participants
n=107 Participants
|
12 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Tq was inflated 15 minutes after injection of Bupivacaine or placebo and remained inflated until subject could no longer tolerate it. Maximum allowable inflation time per session was 60 minutes.15 minutes after either Bupivacaine or placebo injection, Tq was inflated to 100 mm Hg over subjects systolic blood pressure. When the subject found the Tq too uncomfortable, the Tq was deflated and the time documented. Approximately one month later, each subject had the opposite injection of either placebo or Bupivacaine on the same arm, and the duration of Tq inflation was again measured. Due to a strong crossover effect, only the data assessed from the first intervention was analyzed.
Outcome measures
| Measure |
Bupivacaine Axillary Ring on 1st Visit
n=12 Participants
Participants received a subcutaneous axillary ring injection with 0.25% Bupivacaine with epinephrine 1:200.000.
|
Saline Axillary Ring on 1st Visit (Control Group)
n=12 Participants
Participants received a subcutaneous axillary ring injection with normal saline.
|
|---|---|---|
|
Time in Minutes That Tq Remained Inflated
|
30.5 Minutes
Interval 26.1 to 35.0
|
22.4 Minutes
Interval 18.0 to 26.9
|
SECONDARY outcome
Timeframe: Tq will be deflated upon subject's request. VAS is assessed at time of deflation for degree of discomfort prompting deflation request, up to 60 minutes post intervention.A visual analog pain score (VAS) from 0 to 10 was assessed at the time of Tq deflation. 0 indicating no pain, and 10 indicating the worst possible pain. All participants requested deflation prior to the maximum allowable 60 minutes, Subjects were instructed to request deflation at the same degree of discomfort for each visit. Due to a strong crossover effect, only the data assessed from the first intervention was analyzed.
Outcome measures
| Measure |
Bupivacaine Axillary Ring on 1st Visit
n=12 Participants
Participants received a subcutaneous axillary ring injection with 0.25% Bupivacaine with epinephrine 1:200.000.
|
Saline Axillary Ring on 1st Visit (Control Group)
n=12 Participants
Participants received a subcutaneous axillary ring injection with normal saline.
|
|---|---|---|
|
Pain Score at Time of Tq Deflation
|
6.1 scores on a scale
Interval 5.2 to 7.1
|
5.0 scores on a scale
Interval 4.0 to 5.9
|
Adverse Events
Bupivacaine Axillary Ring
Saline Axillary Ring (Control Group)
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Randall F. Coombs, M.D.
Anesthesiology Department, University of NC at Chapel Hill
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place