Trial Outcomes & Findings for Interscalene Block With Liposomal Bupivacaine vs. Interscalene Block With Bupivacaine and Adjuvants (NCT NCT03845894)
NCT ID: NCT03845894
Last Updated: 2023-11-13
Results Overview
Pain levels will be measured by the mean Visual Analogue Scale- Numeric Rating Scale (VAS-NRS). The VAS-NRS is an 11 point scale with 0 (no pain) to 10 (worst possible pain). Higher scores denote worse outcome.
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
25 participants
Primary outcome timeframe
At 48 hours postoperatively
Results posted on
2023-11-13
Participant Flow
Participant milestones
| Measure |
Liposomal Bupivacaine ISB
Liposomal bupivacaine: Interscalene brachial plexus blockade using liposomal bupivacaine (expanded with plain bupivacaine)
|
Bupivacaine With Adjuvants ISB
Bupivacaine with adjuvants: Interscalene brachial plexus blockade using plain bupivacaine with adjuvants: clonidine, epinephrine, buprenorphine, dexamethasone.
|
|---|---|---|
|
Overall Study
STARTED
|
12
|
13
|
|
Overall Study
COMPLETED
|
12
|
13
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Interscalene Block With Liposomal Bupivacaine vs. Interscalene Block With Bupivacaine and Adjuvants
Baseline characteristics by cohort
| Measure |
Liposomal Bupivacaine ISB
n=12 Participants
Liposomal bupivacaine: Interscalene brachial plexus blockade using liposomal bupivacaine (expanded with plain bupivacaine)
|
Bupivacaine With Adjuvants ISB
n=13 Participants
Bupivacaine with adjuvants: Interscalene brachial plexus blockade using plain bupivacaine with adjuvants: clonidine, epinephrine, buprenorphine, dexamethasone.
|
Total
n=25 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
10 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
12 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
12 participants
n=5 Participants
|
13 participants
n=7 Participants
|
25 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: At 48 hours postoperativelyPopulation: The software interface in this website will not allow for AUC as an acceptable outcome to satisfy field entries. Therefore, here the AUC is not reported here, but rather then mean and standard deviation are reported.
Pain levels will be measured by the mean Visual Analogue Scale- Numeric Rating Scale (VAS-NRS). The VAS-NRS is an 11 point scale with 0 (no pain) to 10 (worst possible pain). Higher scores denote worse outcome.
Outcome measures
| Measure |
Liposomal Bupivacaine ISB
n=12 Participants
Liposomal bupivacaine: Interscalene brachial plexus blockade using liposomal bupivacaine (expanded with plain bupivacaine)
|
Bupivacaine With Adjuvants ISB
n=13 Participants
Bupivacaine with adjuvants: Interscalene brachial plexus blockade using plain bupivacaine with adjuvants: clonidine, epinephrine, buprenorphine, dexamethasone.
|
|---|---|---|
|
Average Pain Scores for the First 48 Hours
|
3.2 units on a scale
Standard Deviation 2.0
|
3.6 units on a scale
Standard Deviation 2.4
|
SECONDARY outcome
Timeframe: up to 48 hoursMorphine milligram equivalents (MME) over a 48 hour period
Outcome measures
| Measure |
Liposomal Bupivacaine ISB
n=12 Participants
Liposomal bupivacaine: Interscalene brachial plexus blockade using liposomal bupivacaine (expanded with plain bupivacaine)
|
Bupivacaine With Adjuvants ISB
n=13 Participants
Bupivacaine with adjuvants: Interscalene brachial plexus blockade using plain bupivacaine with adjuvants: clonidine, epinephrine, buprenorphine, dexamethasone.
|
|---|---|---|
|
Postoperative Opioid Consumption for the First 48 Hours
|
22.9 Morphine milligram equivalents (MME)
Standard Deviation 20.6
|
28.5 Morphine milligram equivalents (MME)
Standard Deviation 23
|
SECONDARY outcome
Timeframe: at 48 hoursSatisfaction scale is from 1-5, with the higher score being highest level of satisfaction
Outcome measures
| Measure |
Liposomal Bupivacaine ISB
n=12 Participants
Liposomal bupivacaine: Interscalene brachial plexus blockade using liposomal bupivacaine (expanded with plain bupivacaine)
|
Bupivacaine With Adjuvants ISB
n=13 Participants
Bupivacaine with adjuvants: Interscalene brachial plexus blockade using plain bupivacaine with adjuvants: clonidine, epinephrine, buprenorphine, dexamethasone.
|
|---|---|---|
|
Satisfaction With Surgical Experience
|
4.75 units on a scale
Standard Deviation .45
|
3.46 units on a scale
Standard Deviation 1.56
|
Adverse Events
Liposomal Bupivacaine ISB
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Bupivacaine With Adjuvants ISB
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