Trial Outcomes & Findings for Dose-Response Relationships for Hemidiaphragmatic Paresis Following Ultrasound-Guided Supraclavicular Block (NCT NCT03138577)
NCT ID: NCT03138577
Last Updated: 2020-05-13
Results Overview
Diaphragm motion was recorded during voluntary sniffing fifteen minutes after supraclavicular block with the specified volume of local anesthetic. Blinded investigators reviewed the scans and determined whether the scans were indicative of hemidiaphragmatic paresis (HDP) or not (No HDP). This data was fit to a dose response curve.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
24 participants
Primary outcome timeframe
15 minutes
Results posted on
2020-05-13
Participant Flow
Study subjects were recruited from August 2018 to July 2019. Fifty-nine subjects were assessed for eligibility. Fourteen subjects were excluded or refused to participate, and 21 were eligible but not approached due to the anticipation of insufficient time to complete assessments. Twenty-four patients consented to enrollment.
3 of the 24 enrolled patients were excluded due to baseline abnormal diaphragm motion or inability to visualize the diaphragm on baseline ultrasound scan.
Participant milestones
| Measure |
Dose Cohort 7
Supraclavicular block performed with 5 mL of 2:1 mixture of 1.5% mepivacaine and 0.5% bupivacaine
|
Dose Cohort 6
Supraclavicular block performed with 10 mL of 2:1 mixture of 1.5% mepivacaine and 0.5% bupivacaine
|
Dose Cohort 5
Supraclavicular block performed with 15 mL of 2:1 mixture of 1.5% mepivacaine and 0.5% bupivacaine
|
Dose Cohort 4
Supraclavicular block performed with 20 mL of 2:1 mixture of 1.5% mepivacaine and 0.5% bupivacaine
|
Dose Cohort 3
Supraclavicular block performed with 25 mL of 2:1 mixture of 1.5% mepivacaine and 0.5% bupivacaine
|
Dose Cohort 2
Supraclavicular block performed with 30 mL of 2:1 mixture of 1.5% mepivacaine and 0.5% bupivacaine
|
Dose Cohort 1
Supraclavicular block performed with 35 mL of 2:1 mixture of 1.5% mepivacaine and 0.5% bupivacaine
|
|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
3
|
3
|
3
|
3
|
3
|
3
|
|
Overall Study
COMPLETED
|
3
|
3
|
3
|
3
|
3
|
3
|
3
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
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 |
5 mL
n=3 Participants
5 mL of 2:1 mixture of 1.5% mepivacaine and 0.5% bupivacaine
|
10 mL
n=3 Participants
10 mL of 2:1 mixture of 1.5% mepivacaine and 0.5% bupivacaine
|
15 mL
n=3 Participants
15 mL of 2:1 mixture of 1.5% mepivacaine and 0.5% bupivacaine
|
20 mL
n=3 Participants
20 mL of 2:1 mixture of 1.5% mepivacaine and 0.5% bupivacaine
|
25 mL
n=3 Participants
25 mL of 2:1 mixture of 1.5% mepivacaine and 0.5% bupivacaine
|
30 mL
n=3 Participants
30 mL of 2:1 mixture of 1.5% mepivacaine and 0.5% bupivacaine
|
35 mL
n=3 Participants
35 mL of 2:1 mixture of 1.5% mepivacaine and 0.5% bupivacaine
|
Total
n=21 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=3 Participants
|
1 Participants
n=3 Participants
|
2 Participants
n=3 Participants
|
3 Participants
n=3 Participants
|
1 Participants
n=3 Participants
|
2 Participants
n=3 Participants
|
3 Participants
n=3 Participants
|
13 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=3 Participants
|
2 Participants
n=3 Participants
|
1 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
2 Participants
n=3 Participants
|
1 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
8 Participants
n=21 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=3 Participants
|
3 Participants
n=3 Participants
|
3 Participants
n=3 Participants
|
3 Participants
n=3 Participants
|
3 Participants
n=3 Participants
|
3 Participants
n=3 Participants
|
2 Participants
n=3 Participants
|
20 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
1 Participants
n=3 Participants
|
1 Participants
n=21 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
3 participants
n=3 Participants
|
3 participants
n=3 Participants
|
3 participants
n=3 Participants
|
3 participants
n=3 Participants
|
3 participants
n=3 Participants
|
3 participants
n=3 Participants
|
3 participants
n=3 Participants
|
3 participants
n=21 Participants
|
|
ASA Classification
ASA Class I
|
1 Participants
n=3 Participants
|
1 Participants
n=3 Participants
|
1 Participants
n=3 Participants
|
1 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
1 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
5 Participants
n=21 Participants
|
|
ASA Classification
ASA Class II
|
2 Participants
n=3 Participants
|
2 Participants
n=3 Participants
|
2 Participants
n=3 Participants
|
2 Participants
n=3 Participants
|
3 Participants
n=3 Participants
|
2 Participants
n=3 Participants
|
2 Participants
n=3 Participants
|
15 Participants
n=21 Participants
|
|
ASA Classification
ASA Class III
|
0 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
1 Participants
n=3 Participants
|
1 Participants
n=21 Participants
|
|
Upper Extremity Surgery Location
Proximal to elbow
|
1 Participants
n=3 Participants
|
1 Participants
n=3 Participants
|
2 Participants
n=3 Participants
|
2 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
1 Participants
n=3 Participants
|
2 Participants
n=3 Participants
|
9 Participants
n=21 Participants
|
|
Upper Extremity Surgery Location
Mid arm (at elbow)
|
2 Participants
n=3 Participants
|
2 Participants
n=3 Participants
|
1 Participants
n=3 Participants
|
1 Participants
n=3 Participants
|
2 Participants
n=3 Participants
|
1 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
9 Participants
n=21 Participants
|
|
Upper Extremity Surgery Location
Distal to elbow
|
0 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
1 Participants
n=3 Participants
|
1 Participants
n=3 Participants
|
1 Participants
n=3 Participants
|
3 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 15 minutesDiaphragm motion was recorded during voluntary sniffing fifteen minutes after supraclavicular block with the specified volume of local anesthetic. Blinded investigators reviewed the scans and determined whether the scans were indicative of hemidiaphragmatic paresis (HDP) or not (No HDP). This data was fit to a dose response curve.
Outcome measures
| Measure |
Dose Cohort 7 (5 mL)
n=3 Participants
Supraclavicular block performed with 5 mL of 2:1 mixture of 1.5% mepivacaine and 0.5% bupivacaine
|
Dose Cohort 6 (10 mL)
n=3 Participants
Supraclavicular block performed with 10 mL of 2:1 mixture of 1.5% mepivacaine and 0.5% bupivacaine
|
Dose Cohort 5 (15 mL)
n=3 Participants
Supraclavicular block performed with 15 mL of 2:1 mixture of 1.5% mepivacaine and 0.5% bupivacaine
|
Dose Cohort 4 (20 mL)
n=3 Participants
Supraclavicular block performed with 20 mL of 2:1 mixture of 1.5% mepivacaine and 0.5% bupivacaine
|
Dose Cohort 3 (25 mL)
n=3 Participants
Supraclavicular block performed with 25 mL of 2:1 mixture of 1.5% mepivacaine and 0.5% bupivacaine
|
Dose Cohort 2 (30 mL)
n=3 Participants
Supraclavicular block performed with 30 mL of 2:1 mixture of 1.5% mepivacaine and 0.5% bupivacaine
|
Dose Cohort 1 (35 mL)
n=3 Participants
Supraclavicular block performed with 35 mL of 2:1 mixture of 1.5% mepivacaine and 0.5% bupivacaine
|
|---|---|---|---|---|---|---|---|
|
Number of Subjects With Hemidiaphragmatic Paresis at Various Volumes of Local Anesthetic 15 Minutes After Supraclavicular Block
HDP
|
1 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
3 Participants
|
3 Participants
|
|
Number of Subjects With Hemidiaphragmatic Paresis at Various Volumes of Local Anesthetic 15 Minutes After Supraclavicular Block
No HDP
|
2 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 30 minutesDiaphragm motion was recorded during voluntary sniffing 30 minutes after supraclavicular block with the specified volume of local anesthetic. Blinded investigators reviewed the scans and determined whether the scans were indicative of hemidiaphragmatic paresis (HDP) or not (No HDP). This data was fit to a dose response curve.
Outcome measures
| Measure |
Dose Cohort 7 (5 mL)
n=3 Participants
Supraclavicular block performed with 5 mL of 2:1 mixture of 1.5% mepivacaine and 0.5% bupivacaine
|
Dose Cohort 6 (10 mL)
n=3 Participants
Supraclavicular block performed with 10 mL of 2:1 mixture of 1.5% mepivacaine and 0.5% bupivacaine
|
Dose Cohort 5 (15 mL)
n=3 Participants
Supraclavicular block performed with 15 mL of 2:1 mixture of 1.5% mepivacaine and 0.5% bupivacaine
|
Dose Cohort 4 (20 mL)
n=3 Participants
Supraclavicular block performed with 20 mL of 2:1 mixture of 1.5% mepivacaine and 0.5% bupivacaine
|
Dose Cohort 3 (25 mL)
n=3 Participants
Supraclavicular block performed with 25 mL of 2:1 mixture of 1.5% mepivacaine and 0.5% bupivacaine
|
Dose Cohort 2 (30 mL)
n=3 Participants
Supraclavicular block performed with 30 mL of 2:1 mixture of 1.5% mepivacaine and 0.5% bupivacaine
|
Dose Cohort 1 (35 mL)
n=3 Participants
Supraclavicular block performed with 35 mL of 2:1 mixture of 1.5% mepivacaine and 0.5% bupivacaine
|
|---|---|---|---|---|---|---|---|
|
Number of Subjects With Hemidiaphragmatic Paresis at Various Volumes of Local Anesthetic 30 Minutes After Supraclavicular Block
HDP
|
1 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
3 Participants
|
3 Participants
|
3 Participants
|
|
Number of Subjects With Hemidiaphragmatic Paresis at Various Volumes of Local Anesthetic 30 Minutes After Supraclavicular Block
No HDP
|
2 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 30 minutesThe change of the absolute value of NIF from the baseline measurement to that at 30 minutes after the block
Outcome measures
| Measure |
Dose Cohort 7 (5 mL)
n=14 Participants
Supraclavicular block performed with 5 mL of 2:1 mixture of 1.5% mepivacaine and 0.5% bupivacaine
|
Dose Cohort 6 (10 mL)
n=7 Participants
Supraclavicular block performed with 10 mL of 2:1 mixture of 1.5% mepivacaine and 0.5% bupivacaine
|
Dose Cohort 5 (15 mL)
Supraclavicular block performed with 15 mL of 2:1 mixture of 1.5% mepivacaine and 0.5% bupivacaine
|
Dose Cohort 4 (20 mL)
Supraclavicular block performed with 20 mL of 2:1 mixture of 1.5% mepivacaine and 0.5% bupivacaine
|
Dose Cohort 3 (25 mL)
Supraclavicular block performed with 25 mL of 2:1 mixture of 1.5% mepivacaine and 0.5% bupivacaine
|
Dose Cohort 2 (30 mL)
Supraclavicular block performed with 30 mL of 2:1 mixture of 1.5% mepivacaine and 0.5% bupivacaine
|
Dose Cohort 1 (35 mL)
Supraclavicular block performed with 35 mL of 2:1 mixture of 1.5% mepivacaine and 0.5% bupivacaine
|
|---|---|---|---|---|---|---|---|
|
Change in Negative Inspiratory Force (NIF) at 30 Minutes
|
-7.5 cm H2O
Interval -22.0 to 0.0
|
0 cm H2O
Interval -10.0 to 0.0
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 15 minutesAs described in the protocol, each subject's block was assessed via motor and sensory exam at 15 minutes and given a score (0-20), with 20 being a perfect block and any score less than 10 indicating an ineffective block. A dose response curve was generated for block score with different volumes of local anesthetic administered.
Outcome measures
| Measure |
Dose Cohort 7 (5 mL)
n=3 Participants
Supraclavicular block performed with 5 mL of 2:1 mixture of 1.5% mepivacaine and 0.5% bupivacaine
|
Dose Cohort 6 (10 mL)
n=3 Participants
Supraclavicular block performed with 10 mL of 2:1 mixture of 1.5% mepivacaine and 0.5% bupivacaine
|
Dose Cohort 5 (15 mL)
n=3 Participants
Supraclavicular block performed with 15 mL of 2:1 mixture of 1.5% mepivacaine and 0.5% bupivacaine
|
Dose Cohort 4 (20 mL)
n=3 Participants
Supraclavicular block performed with 20 mL of 2:1 mixture of 1.5% mepivacaine and 0.5% bupivacaine
|
Dose Cohort 3 (25 mL)
n=3 Participants
Supraclavicular block performed with 25 mL of 2:1 mixture of 1.5% mepivacaine and 0.5% bupivacaine
|
Dose Cohort 2 (30 mL)
n=3 Participants
Supraclavicular block performed with 30 mL of 2:1 mixture of 1.5% mepivacaine and 0.5% bupivacaine
|
Dose Cohort 1 (35 mL)
n=3 Participants
Supraclavicular block performed with 35 mL of 2:1 mixture of 1.5% mepivacaine and 0.5% bupivacaine
|
|---|---|---|---|---|---|---|---|
|
Dose Response Curve for Motor and Sensory Block 15 Minutes After Block
Subject 1/3
|
1 score on a scale
|
11 score on a scale
|
7 score on a scale
|
2 score on a scale
|
20 score on a scale
|
15 score on a scale
|
11 score on a scale
|
|
Dose Response Curve for Motor and Sensory Block 15 Minutes After Block
Subject 2/3
|
12 score on a scale
|
12 score on a scale
|
0 score on a scale
|
1 score on a scale
|
19 score on a scale
|
15 score on a scale
|
15 score on a scale
|
|
Dose Response Curve for Motor and Sensory Block 15 Minutes After Block
Subject 3/3
|
10 score on a scale
|
0 score on a scale
|
18 score on a scale
|
0 score on a scale
|
5 score on a scale
|
16 score on a scale
|
19 score on a scale
|
SECONDARY outcome
Timeframe: 30 minutesAs described in the protocol, each subject's block was assessed via motor and sensory exam at 30 minutes and given a score (0-20), with 20 being a perfect block and any score less than 10 indicating an ineffective block. A dose response curve was generated for block score with different volumes of local anesthetic administered.
Outcome measures
| Measure |
Dose Cohort 7 (5 mL)
n=3 Participants
Supraclavicular block performed with 5 mL of 2:1 mixture of 1.5% mepivacaine and 0.5% bupivacaine
|
Dose Cohort 6 (10 mL)
n=3 Participants
Supraclavicular block performed with 10 mL of 2:1 mixture of 1.5% mepivacaine and 0.5% bupivacaine
|
Dose Cohort 5 (15 mL)
n=3 Participants
Supraclavicular block performed with 15 mL of 2:1 mixture of 1.5% mepivacaine and 0.5% bupivacaine
|
Dose Cohort 4 (20 mL)
n=3 Participants
Supraclavicular block performed with 20 mL of 2:1 mixture of 1.5% mepivacaine and 0.5% bupivacaine
|
Dose Cohort 3 (25 mL)
n=3 Participants
Supraclavicular block performed with 25 mL of 2:1 mixture of 1.5% mepivacaine and 0.5% bupivacaine
|
Dose Cohort 2 (30 mL)
n=3 Participants
Supraclavicular block performed with 30 mL of 2:1 mixture of 1.5% mepivacaine and 0.5% bupivacaine
|
Dose Cohort 1 (35 mL)
n=3 Participants
Supraclavicular block performed with 35 mL of 2:1 mixture of 1.5% mepivacaine and 0.5% bupivacaine
|
|---|---|---|---|---|---|---|---|
|
Dose Response Curve for Motor and Sensory Block Score 30 Minutes After Block
Subject 1 of 3
|
2 score on a scale
|
14 score on a scale
|
8 score on a scale
|
20 score on a scale
|
20 score on a scale
|
14 score on a scale
|
15 score on a scale
|
|
Dose Response Curve for Motor and Sensory Block Score 30 Minutes After Block
Subject 2 of 3
|
18 score on a scale
|
14 score on a scale
|
2 score on a scale
|
10 score on a scale
|
20 score on a scale
|
16 score on a scale
|
18 score on a scale
|
|
Dose Response Curve for Motor and Sensory Block Score 30 Minutes After Block
Subject 3 of 3
|
10 score on a scale
|
12 score on a scale
|
18 score on a scale
|
16 score on a scale
|
16 score on a scale
|
16 score on a scale
|
19 score on a scale
|
SECONDARY outcome
Timeframe: 30 minutesThe change in room air oxygen saturation from baseline to 30 minutes after the block was calculated.
Outcome measures
| Measure |
Dose Cohort 7 (5 mL)
n=14 Participants
Supraclavicular block performed with 5 mL of 2:1 mixture of 1.5% mepivacaine and 0.5% bupivacaine
|
Dose Cohort 6 (10 mL)
n=7 Participants
Supraclavicular block performed with 10 mL of 2:1 mixture of 1.5% mepivacaine and 0.5% bupivacaine
|
Dose Cohort 5 (15 mL)
Supraclavicular block performed with 15 mL of 2:1 mixture of 1.5% mepivacaine and 0.5% bupivacaine
|
Dose Cohort 4 (20 mL)
Supraclavicular block performed with 20 mL of 2:1 mixture of 1.5% mepivacaine and 0.5% bupivacaine
|
Dose Cohort 3 (25 mL)
Supraclavicular block performed with 25 mL of 2:1 mixture of 1.5% mepivacaine and 0.5% bupivacaine
|
Dose Cohort 2 (30 mL)
Supraclavicular block performed with 30 mL of 2:1 mixture of 1.5% mepivacaine and 0.5% bupivacaine
|
Dose Cohort 1 (35 mL)
Supraclavicular block performed with 35 mL of 2:1 mixture of 1.5% mepivacaine and 0.5% bupivacaine
|
|---|---|---|---|---|---|---|---|
|
Change in Room Air Oxygen Saturation at 30 Minutes.
|
-1 percent
Interval -2.0 to 0.0
|
0 percent
Interval 0.0 to 0.0
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 30 minutes30 minutes after the block, patients were asked to rate any symptoms of dyspnea on a scale of 0 (no trouble breathing) to 10 (extreme trouble breathing).
Outcome measures
| Measure |
Dose Cohort 7 (5 mL)
n=14 Participants
Supraclavicular block performed with 5 mL of 2:1 mixture of 1.5% mepivacaine and 0.5% bupivacaine
|
Dose Cohort 6 (10 mL)
n=7 Participants
Supraclavicular block performed with 10 mL of 2:1 mixture of 1.5% mepivacaine and 0.5% bupivacaine
|
Dose Cohort 5 (15 mL)
Supraclavicular block performed with 15 mL of 2:1 mixture of 1.5% mepivacaine and 0.5% bupivacaine
|
Dose Cohort 4 (20 mL)
Supraclavicular block performed with 20 mL of 2:1 mixture of 1.5% mepivacaine and 0.5% bupivacaine
|
Dose Cohort 3 (25 mL)
Supraclavicular block performed with 25 mL of 2:1 mixture of 1.5% mepivacaine and 0.5% bupivacaine
|
Dose Cohort 2 (30 mL)
Supraclavicular block performed with 30 mL of 2:1 mixture of 1.5% mepivacaine and 0.5% bupivacaine
|
Dose Cohort 1 (35 mL)
Supraclavicular block performed with 35 mL of 2:1 mixture of 1.5% mepivacaine and 0.5% bupivacaine
|
|---|---|---|---|---|---|---|---|
|
Subjective Dyspnea 30 Minutes After Block
|
0 score on a scale
Interval 0.0 to 2.0
|
0 score on a scale
Interval 0.0 to 0.0
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
Dose Cohort 7 (5 mL)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Dose Cohort 6 (10 mL)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Dose Cohort 5 (15 mL)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Dose Cohort 4 (20 mL)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Dose Cohort 3 (25 mL)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Dose Cohort 2 (30 mL)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Dose Cohort 1 (35 mL)
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