Trial Outcomes & Findings for Single Shot Versus OnQ Pump in Extremity Fractures (NCT NCT02280291)
NCT ID: NCT02280291
Last Updated: 2020-03-30
Results Overview
The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between 0 ("no pain") and 10 ("worst pain").
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
100 participants
Primary outcome timeframe
2 weeks, 6 weeks
Results posted on
2020-03-30
Participant Flow
Participant milestones
| Measure |
Ankle Single Shot Block (SSB)
Ankle SSB: general anesthesia/sedation with a single shot; Primary predictor variable: single shot block, a 22 gauge, 3.5 inch needle will be used and 20cc of 2% lidocaine with 1:200,000 epinephrine + 20cc of 0.5% bupivacaine with 1:300,000 epinephrine will be injected around the nerve after confirming negative aspiration every 5 cc.
|
Ankle OnQ (Continuos Sedation OnQ Pump)
Ankle OnQ: versus regional block with continuous infusion using an OnQ pump. 17 gauge Tuohy needle will be used and 20cc of 2% lidocaine with epinephrine +20cc of 0.5% bupivacaine with1:300,000epinephrine will be injected around the nerve after confirming negative aspiration every 5cc.
|
DR SSB
DR SSB: general anesthesia/sedationwith a single shot; general anesthesia/sedation with a single shot; Primary predictor variable: single shot block, a 22 gauge, 3.5 inch needle will be used and 20cc of 2% lidocaine with 1:200,000 epinephrine + 20cc of 0.5% bupivacaine with 1:300,000 epinephrine will be injected around the nerve after confirming negative aspiration every 5 cc.
|
DR OnQ
DR OnQ: versus regional block with continuous infusion using an OnQ pump. 17 gauge Tuohy needle will be used and 20cc of 2% lidocaine with epinephrine +20cc of 0.5% bupivacaine with1:300,000epinephrine will be injected around the nerve after confirming negative aspiration every 5cc.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
25
|
25
|
24
|
26
|
|
Overall Study
COMPLETED
|
21
|
23
|
21
|
18
|
|
Overall Study
NOT COMPLETED
|
4
|
2
|
3
|
8
|
Reasons for withdrawal
| Measure |
Ankle Single Shot Block (SSB)
Ankle SSB: general anesthesia/sedation with a single shot; Primary predictor variable: single shot block, a 22 gauge, 3.5 inch needle will be used and 20cc of 2% lidocaine with 1:200,000 epinephrine + 20cc of 0.5% bupivacaine with 1:300,000 epinephrine will be injected around the nerve after confirming negative aspiration every 5 cc.
|
Ankle OnQ (Continuos Sedation OnQ Pump)
Ankle OnQ: versus regional block with continuous infusion using an OnQ pump. 17 gauge Tuohy needle will be used and 20cc of 2% lidocaine with epinephrine +20cc of 0.5% bupivacaine with1:300,000epinephrine will be injected around the nerve after confirming negative aspiration every 5cc.
|
DR SSB
DR SSB: general anesthesia/sedationwith a single shot; general anesthesia/sedation with a single shot; Primary predictor variable: single shot block, a 22 gauge, 3.5 inch needle will be used and 20cc of 2% lidocaine with 1:200,000 epinephrine + 20cc of 0.5% bupivacaine with 1:300,000 epinephrine will be injected around the nerve after confirming negative aspiration every 5 cc.
|
DR OnQ
DR OnQ: versus regional block with continuous infusion using an OnQ pump. 17 gauge Tuohy needle will be used and 20cc of 2% lidocaine with epinephrine +20cc of 0.5% bupivacaine with1:300,000epinephrine will be injected around the nerve after confirming negative aspiration every 5cc.
|
|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
1
|
3
|
8
|
|
Overall Study
Protocol Violation
|
1
|
0
|
0
|
0
|
|
Overall Study
Other
|
1
|
1
|
0
|
0
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Ankle Single Shot Block (SSB)
n=25 Participants
Ankle SSB: general anesthesia/sedation with a single shot; Primary predictor variable: single shot block, a 22 gauge, 3.5 inch needle will be used and 20cc of 2% lidocaine with 1:200,000 epinephrine + 20cc of 0.5% bupivacaine with 1:300,000 epinephrine will be injected around the nerve after confirming negative aspiration every 5 cc.
|
Ankle OnQ (Continuos Sedation OnQ Pump)
n=25 Participants
Ankle OnQ: versus regional block with continuous infusion using an OnQ pump. 17 gauge Tuohy needle will be used and 20cc of 2% lidocaine with epinephrine +20cc of 0.5% bupivacaine with1:300,000epinephrine will be injected around the nerve after confirming negative aspiration every 5cc.
|
DR SSB
n=24 Participants
DR SSB: general anesthesia/sedationwith a single shot; general anesthesia/sedation with a single shot; Primary predictor variable: single shot block, a 22 gauge, 3.5 inch needle will be used and 20cc of 2% lidocaine with 1:200,000 epinephrine + 20cc of 0.5% bupivacaine with 1:300,000 epinephrine will be injected around the nerve after confirming negative aspiration every 5 cc.
|
DR OnQ
n=26 Participants
DR OnQ: versus regional block with continuous infusion using an OnQ pump. 17 gauge Tuohy needle will be used and 20cc of 2% lidocaine with epinephrine +20cc of 0.5% bupivacaine with1:300,000epinephrine will be injected around the nerve after confirming negative aspiration every 5cc.
|
Total
n=100 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=25 Participants
|
0 Participants
n=25 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=26 Participants
|
0 Participants
n=100 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
22 Participants
n=25 Participants
|
21 Participants
n=25 Participants
|
20 Participants
n=24 Participants
|
20 Participants
n=26 Participants
|
83 Participants
n=100 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=25 Participants
|
4 Participants
n=25 Participants
|
4 Participants
n=24 Participants
|
6 Participants
n=26 Participants
|
17 Participants
n=100 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=25 Participants
|
11 Participants
n=25 Participants
|
17 Participants
n=24 Participants
|
16 Participants
n=26 Participants
|
59 Participants
n=100 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=25 Participants
|
14 Participants
n=25 Participants
|
7 Participants
n=24 Participants
|
10 Participants
n=26 Participants
|
41 Participants
n=100 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
25 Participants
n=25 Participants
|
25 Participants
n=25 Participants
|
24 Participants
n=24 Participants
|
26 Participants
n=26 Participants
|
100 Participants
n=100 Participants
|
PRIMARY outcome
Timeframe: 2 weeks, 6 weeksPopulation: Some of the number of participants analyzed differs from the overall number analyzed because some participants were lost to follow up.
The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between 0 ("no pain") and 10 ("worst pain").
Outcome measures
| Measure |
Ankle Single Shot Block (SSB)
n=20 Participants
Ankle SSB: general anesthesia/sedation with a single shot; Primary predictor variable: single shot block, a 22 gauge, 3.5 inch needle will be used and 20cc of 2% lidocaine with 1:200,000 epinephrine + 20cc of 0.5% bupivacaine with 1:300,000 epinephrine will be injected around the nerve after confirming negative aspiration every 5 cc.
|
Ankle OnQ (Continuos Sedation OnQ Pump)
n=23 Participants
Ankle OnQ: versus regional block with continuous infusion using an OnQ pump. 17 gauge Tuohy needle will be used and 20cc of 2% lidocaine with epinephrine +20cc of 0.5% bupivacaine with1:300,000epinephrine will be injected around the nerve after confirming negative aspiration every 5cc.
|
DR SSB
n=13 Participants
DR SSB: general anesthesia/sedationwith a single shot; general anesthesia/sedation with a single shot; Primary predictor variable: single shot block, a 22 gauge, 3.5 inch needle will be used and 20cc of 2% lidocaine with 1:200,000 epinephrine + 20cc of 0.5% bupivacaine with 1:300,000 epinephrine will be injected around the nerve after confirming negative aspiration every 5 cc.
|
DR OnQ
n=12 Participants
DR OnQ: versus regional block with continuous infusion using an OnQ pump. 17 gauge Tuohy needle will be used and 20cc of 2% lidocaine with epinephrine +20cc of 0.5% bupivacaine with1:300,000epinephrine will be injected around the nerve after confirming negative aspiration every 5cc.
|
|---|---|---|---|---|
|
Change in Score on Visual Analog Scale (VAS)
6 weeks post-op
|
1.8 score on a scale
Standard Deviation 2.53
|
0.62 score on a scale
Standard Deviation 0.98
|
3.46 score on a scale
Standard Deviation 2.96
|
2.58 score on a scale
Standard Deviation 2.91
|
|
Change in Score on Visual Analog Scale (VAS)
2 weeks post-op
|
3.28 score on a scale
Standard Deviation 2.26
|
1.47 score on a scale
Standard Deviation 1.42
|
3.62 score on a scale
Standard Deviation 1.71
|
3.91 score on a scale
Standard Deviation 3.12
|
SECONDARY outcome
Timeframe: 2 Weeks, 6 WeeksPopulation: Data was not collected for the Ankle SSB and Ankle OnQ arms, as the DASH scale is upper extremity-specific (including only arm, shoulder, and hand disabilities).
The disabilities of the arm, shoulder and hand (DASH) questionnaire is a self-administered region-specific outcome instrument developed as a measure of self-rated upper-extremity disability and symptoms. The DASH consists mainly of a 30-item disability/symptom scale, scored 0 (no disability) to 100.
Outcome measures
| Measure |
Ankle Single Shot Block (SSB)
n=13 Participants
Ankle SSB: general anesthesia/sedation with a single shot; Primary predictor variable: single shot block, a 22 gauge, 3.5 inch needle will be used and 20cc of 2% lidocaine with 1:200,000 epinephrine + 20cc of 0.5% bupivacaine with 1:300,000 epinephrine will be injected around the nerve after confirming negative aspiration every 5 cc.
|
Ankle OnQ (Continuos Sedation OnQ Pump)
n=12 Participants
Ankle OnQ: versus regional block with continuous infusion using an OnQ pump. 17 gauge Tuohy needle will be used and 20cc of 2% lidocaine with epinephrine +20cc of 0.5% bupivacaine with1:300,000epinephrine will be injected around the nerve after confirming negative aspiration every 5cc.
|
DR SSB
DR SSB: general anesthesia/sedationwith a single shot; general anesthesia/sedation with a single shot; Primary predictor variable: single shot block, a 22 gauge, 3.5 inch needle will be used and 20cc of 2% lidocaine with 1:200,000 epinephrine + 20cc of 0.5% bupivacaine with 1:300,000 epinephrine will be injected around the nerve after confirming negative aspiration every 5 cc.
|
DR OnQ
DR OnQ: versus regional block with continuous infusion using an OnQ pump. 17 gauge Tuohy needle will be used and 20cc of 2% lidocaine with epinephrine +20cc of 0.5% bupivacaine with1:300,000epinephrine will be injected around the nerve after confirming negative aspiration every 5cc.
|
|---|---|---|---|---|
|
Disability of the Arm, Shoulder and Hand (DASH) Score
2 weeks
|
53.97 score on a scale
Standard Deviation 18.56
|
62.17 score on a scale
Standard Deviation 19.94
|
—
|
—
|
|
Disability of the Arm, Shoulder and Hand (DASH) Score
6 weeks
|
36.78 score on a scale
Standard Deviation 25.77
|
45.69 score on a scale
Standard Deviation 32.36
|
—
|
—
|
Adverse Events
Ankle Single Shot Block (SSB)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Ankle OnQ (Continuos Sedation OnQ Pump)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
DR SSB
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
DR OnQ
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