Trial Outcomes & Findings for Analgesia Duration of Dexamethasone, Buprenorphine, or Clonidine With Ropivacaine for Interscalene Nerve Block (NCT NCT03117140)
NCT ID: NCT03117140
Last Updated: 2018-07-03
Results Overview
Patients are called 1-3 days post-operatively to assess when the analgesia of their nerve block wore off
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
160 participants
Primary outcome timeframe
1-3 days post-operative
Results posted on
2018-07-03
Participant Flow
Participant milestones
| Measure |
Plain Ropiviciane
Plain Ropivicaine 0.75%, (225 mg) total volume 32 cc for interscalene block given pre-operatively
Ropivicaine 0.75%: Only ropivicaine 0.75% is administered for this arm of the interscalene block
|
Ropiviciane + Buprenorphine
A mixture of 0.75% ropivacaine with 300 mcg buprenorphine, total volume 32 cc for interscalene block given pre-operatively
Ropivicaine 0.75% + 300 mcg Buprenorphine: Ropivicaine 0.75% + 300 mcg Buprenorphine is administered for this arm of the interscalene block
|
Ropivicaine + Clonidine
A mixture of 0.75% ropivacaine with 75 mcg clonidine, total volume 32 cc for interscalene block given pre-operatively
Ropivicaine 0.75% + 75 mcg clonidine: Ropivicaine 0.75% + 75 mcg Clonidine is administered for this arm of the interscalene block
|
Ropiviciane + Dexamethasone
A mixture of 0.75% ropivacaine with and 8 mg dexamethasone, total volume 32 cc for interscalene block given pre-operatively
Ropivicaine 0.75% + 8 mg dexamethasone: Ropivicaine 0.75% + 8 mg Dexamethasone is administered for this arm of the interscalene block
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
40
|
40
|
40
|
40
|
|
Overall Study
COMPLETED
|
40
|
40
|
40
|
40
|
|
Overall Study
NOT COMPLETED
|
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 |
Plain Ropivacaine
n=40 Participants
Plain ropivacaine 0.75%, (225 mg) total volume 32 cc for interscalene block given pre-operatively
Ropivacaine 0.75%: Only ropivacaine 0.75% is administered for this arm of the interscalene block
|
Ropivacaine + Buprenorphine
n=40 Participants
A mixture of 0.75% ropivacaine with 300 mcg buprenorphine, total volume 32 cc for interscalene block given pre-operatively
Ropivacaine 0.75% + 300 mcg buprenorphine: Ropivacaine 0.75% + 300 mcg buprenorphine is administered for this arm of the interscalene block
|
Ropivacaine + Clonidine
n=40 Participants
A mixture of 0.75% ropivacaine with 75 mcg clonidine, total volume 32 cc for interscalene block given pre-operatively
Ropivacaine 0.75% + 75 mcg clonidine: Ropivacaine 0.75% + 75 mcg clonidine is administered for this arm of the interscalene block
|
Ropivacaine + Dexamethasone
n=40 Participants
A mixture of 0.75% ropivacaine with and 8 mg dexamethasone, total volume 32 cc for interscalene block given pre-operatively
Ropivacaine 0.75% + 8 mg dexamethasone: Ropivacaine 0.75% + 8 mg dexamethasone is administered for this arm of the interscalene block
|
Total
n=160 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=40 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=160 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
37 Participants
n=40 Participants
|
38 Participants
n=40 Participants
|
39 Participants
n=40 Participants
|
40 Participants
n=40 Participants
|
154 Participants
n=160 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=40 Participants
|
2 Participants
n=40 Participants
|
1 Participants
n=40 Participants
|
0 Participants
n=40 Participants
|
6 Participants
n=160 Participants
|
|
Age, Continuous
|
45.38 years
STANDARD_DEVIATION 14.39 • n=40 Participants
|
44.8 years
STANDARD_DEVIATION 14.2 • n=40 Participants
|
43.1 years
STANDARD_DEVIATION 14.74 • n=40 Participants
|
42.3 years
STANDARD_DEVIATION 13.71 • n=40 Participants
|
43.89 years
STANDARD_DEVIATION 14.19 • n=160 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=40 Participants
|
9 Participants
n=40 Participants
|
7 Participants
n=40 Participants
|
9 Participants
n=40 Participants
|
40 Participants
n=160 Participants
|
|
Sex: Female, Male
Male
|
25 Participants
n=40 Participants
|
31 Participants
n=40 Participants
|
33 Participants
n=40 Participants
|
31 Participants
n=40 Participants
|
120 Participants
n=160 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
ASA (American Society of Anesthesiolgy) Classification system
ASA classification I
|
13 Participants
n=40 Participants
|
14 Participants
n=40 Participants
|
15 Participants
n=40 Participants
|
17 Participants
n=40 Participants
|
59 Participants
n=160 Participants
|
|
ASA (American Society of Anesthesiolgy) Classification system
ASA classification II
|
23 Participants
n=40 Participants
|
24 Participants
n=40 Participants
|
18 Participants
n=40 Participants
|
21 Participants
n=40 Participants
|
86 Participants
n=160 Participants
|
|
ASA (American Society of Anesthesiolgy) Classification system
ASA classification III
|
4 Participants
n=40 Participants
|
2 Participants
n=40 Participants
|
7 Participants
n=40 Participants
|
2 Participants
n=40 Participants
|
15 Participants
n=160 Participants
|
|
Weight
|
98.82 kilograms
STANDARD_DEVIATION 22.71 • n=40 Participants
|
98.13 kilograms
STANDARD_DEVIATION 21.47 • n=40 Participants
|
99.78 kilograms
STANDARD_DEVIATION 25.95 • n=40 Participants
|
95.63 kilograms
STANDARD_DEVIATION 21.41 • n=40 Participants
|
98.09 kilograms
STANDARD_DEVIATION 22.79 • n=160 Participants
|
PRIMARY outcome
Timeframe: 1-3 days post-operativePatients are called 1-3 days post-operatively to assess when the analgesia of their nerve block wore off
Outcome measures
| Measure |
Plain Ropivacaine
n=40 Participants
Plain Ropivacaine 0.75%, (225 mg) total volume 32 cc for interscalene block given pre-operatively
Ropivacaine 0.75%: Only ropivacaine 0.75% is administered for this arm of the interscalene block
|
Ropivacaine + Buprenorphine
n=40 Participants
A mixture of 0.75% ropivacaine with 300 mcg buprenorphine, total volume 32 cc for interscalene block given pre-operatively
Ropivacaine 0.75% + 300 mcg Buprenorphine: Ropivacaine 0.75% + 300 mcg Buprenorphine is administered for this arm of the interscalene block
|
Ropivacaine + Clonidine
n=40 Participants
A mixture of 0.75% ropivacaine with 75 mcg clonidine, total volume 32 cc for interscalene block given pre-operatively
Ropivacaine 0.75% + 75 mcg clonidine: Ropivacaine 0.75% + 75 mcg clonidine is administered for this arm of the interscalene block
|
Ropivacaine + Dexamethasone
n=40 Participants
A mixture of 0.75% ropivacaine with and 8 mg dexamethasone, total volume 32 cc for interscalene block given pre-operatively
Ropivacaine 0.75% + 8 mg dexamethasone: Ropivacaine 0.75% + 8 mg dexamethasone is administered for this arm of the interscalene block
|
|---|---|---|---|---|
|
Duration of Analgesia
|
911 minutes
Interval 652.0 to 1300.0
|
1026.5 minutes
Interval 756.5 to 1392.5
|
1181 minutes
Interval 880.5 to 1528.5
|
982 minutes
Interval 799.0 to 1270.0
|
SECONDARY outcome
Timeframe: Day onePatients are assessed from needle removal to when they are no longer able to feel cold on the blocked extremity
Outcome measures
| Measure |
Plain Ropivacaine
n=40 Participants
Plain Ropivacaine 0.75%, (225 mg) total volume 32 cc for interscalene block given pre-operatively
Ropivacaine 0.75%: Only ropivacaine 0.75% is administered for this arm of the interscalene block
|
Ropivacaine + Buprenorphine
n=40 Participants
A mixture of 0.75% ropivacaine with 300 mcg buprenorphine, total volume 32 cc for interscalene block given pre-operatively
Ropivacaine 0.75% + 300 mcg Buprenorphine: Ropivacaine 0.75% + 300 mcg Buprenorphine is administered for this arm of the interscalene block
|
Ropivacaine + Clonidine
n=40 Participants
A mixture of 0.75% ropivacaine with 75 mcg clonidine, total volume 32 cc for interscalene block given pre-operatively
Ropivacaine 0.75% + 75 mcg clonidine: Ropivacaine 0.75% + 75 mcg clonidine is administered for this arm of the interscalene block
|
Ropivacaine + Dexamethasone
n=40 Participants
A mixture of 0.75% ropivacaine with and 8 mg dexamethasone, total volume 32 cc for interscalene block given pre-operatively
Ropivacaine 0.75% + 8 mg dexamethasone: Ropivacaine 0.75% + 8 mg dexamethasone is administered for this arm of the interscalene block
|
|---|---|---|---|---|
|
Block Set up Time
|
6 minutes
Interval 3.0 to 9.0
|
3 minutes
Interval 3.0 to 6.0
|
6 minutes
Interval 3.0 to 6.0
|
4.5 minutes
Interval 3.0 to 10.5
|
SECONDARY outcome
Timeframe: Day 1-3Patients are called 1-3 days post-operatively to assess when the sensory component of their nerve block wore off
Outcome measures
| Measure |
Plain Ropivacaine
n=40 Participants
Plain Ropivacaine 0.75%, (225 mg) total volume 32 cc for interscalene block given pre-operatively
Ropivacaine 0.75%: Only ropivacaine 0.75% is administered for this arm of the interscalene block
|
Ropivacaine + Buprenorphine
n=40 Participants
A mixture of 0.75% ropivacaine with 300 mcg buprenorphine, total volume 32 cc for interscalene block given pre-operatively
Ropivacaine 0.75% + 300 mcg Buprenorphine: Ropivacaine 0.75% + 300 mcg Buprenorphine is administered for this arm of the interscalene block
|
Ropivacaine + Clonidine
n=40 Participants
A mixture of 0.75% ropivacaine with 75 mcg clonidine, total volume 32 cc for interscalene block given pre-operatively
Ropivacaine 0.75% + 75 mcg clonidine: Ropivacaine 0.75% + 75 mcg clonidine is administered for this arm of the interscalene block
|
Ropivacaine + Dexamethasone
n=40 Participants
A mixture of 0.75% ropivacaine with and 8 mg dexamethasone, total volume 32 cc for interscalene block given pre-operatively
Ropivacaine 0.75% + 8 mg dexamethasone: Ropivacaine 0.75% + 8 mg dexamethasone is administered for this arm of the interscalene block
|
|---|---|---|---|---|
|
Sensory Duration of Block
|
923.5 minutes
Interval 652.0 to 1304.0
|
982 minutes
Interval 705.0 to 1189.0
|
940.5 minutes
Interval 736.5 to 1234.0
|
1066 minutes
Interval 797.0 to 1240.0
|
SECONDARY outcome
Timeframe: 1-3 daysPopulation: 1 patient in the Plain Ropivacaine group and the Ropivacaine and Buprenorphine group did not complete the survey about vomiting at home and therefore was not included in the analysis
Patients are called 1-3 days post-operatively to assess if they had any side effects of the adjuvants such as nausea, vomiting or itching. There blood pressure is looked at pre-op and compared to post-op. Any prolonged PACU (Post Anesthesia Care Unit) stay for sedation is recorded.
Outcome measures
| Measure |
Plain Ropivacaine
n=39 Participants
Plain Ropivacaine 0.75%, (225 mg) total volume 32 cc for interscalene block given pre-operatively
Ropivacaine 0.75%: Only ropivacaine 0.75% is administered for this arm of the interscalene block
|
Ropivacaine + Buprenorphine
n=39 Participants
A mixture of 0.75% ropivacaine with 300 mcg buprenorphine, total volume 32 cc for interscalene block given pre-operatively
Ropivacaine 0.75% + 300 mcg Buprenorphine: Ropivacaine 0.75% + 300 mcg Buprenorphine is administered for this arm of the interscalene block
|
Ropivacaine + Clonidine
n=40 Participants
A mixture of 0.75% ropivacaine with 75 mcg clonidine, total volume 32 cc for interscalene block given pre-operatively
Ropivacaine 0.75% + 75 mcg clonidine: Ropivacaine 0.75% + 75 mcg clonidine is administered for this arm of the interscalene block
|
Ropivacaine + Dexamethasone
n=40 Participants
A mixture of 0.75% ropivacaine with and 8 mg dexamethasone, total volume 32 cc for interscalene block given pre-operatively
Ropivacaine 0.75% + 8 mg dexamethasone: Ropivacaine 0.75% + 8 mg dexamethasone is administered for this arm of the interscalene block
|
|---|---|---|---|---|
|
Patient Reporting Vomiting at Home
|
0 Participants
|
3 Participants
|
2 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Post-op Day 0 (Baseline)Vomiting in PACU (Post-Anesthesia Care Unit) for patients was looked at
Outcome measures
| Measure |
Plain Ropivacaine
n=40 Participants
Plain Ropivacaine 0.75%, (225 mg) total volume 32 cc for interscalene block given pre-operatively
Ropivacaine 0.75%: Only ropivacaine 0.75% is administered for this arm of the interscalene block
|
Ropivacaine + Buprenorphine
n=40 Participants
A mixture of 0.75% ropivacaine with 300 mcg buprenorphine, total volume 32 cc for interscalene block given pre-operatively
Ropivacaine 0.75% + 300 mcg Buprenorphine: Ropivacaine 0.75% + 300 mcg Buprenorphine is administered for this arm of the interscalene block
|
Ropivacaine + Clonidine
n=40 Participants
A mixture of 0.75% ropivacaine with 75 mcg clonidine, total volume 32 cc for interscalene block given pre-operatively
Ropivacaine 0.75% + 75 mcg clonidine: Ropivacaine 0.75% + 75 mcg clonidine is administered for this arm of the interscalene block
|
Ropivacaine + Dexamethasone
n=40 Participants
A mixture of 0.75% ropivacaine with and 8 mg dexamethasone, total volume 32 cc for interscalene block given pre-operatively
Ropivacaine 0.75% + 8 mg dexamethasone: Ropivacaine 0.75% + 8 mg dexamethasone is administered for this arm of the interscalene block
|
|---|---|---|---|---|
|
Number of Patients Vomiting in the PACU (Post-Anesthesia Care Unit)
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 1-3 daysPopulation: 1 patient in the Plain Ropivacaine group and the Ropivacaine and Buprenorphine group did not complete the survey about nausea at home and therefore was not included in the analysis
Patients are called 1-3 days post-operatively to assess if they had any side effects of the adjuvants such as nausea, vomiting or itching. There blood pressure is looked at pre-op and compared to post-op. Any prolonged PACU (Post Anesthesia Care Unit) stay for sedation is recorded.
Outcome measures
| Measure |
Plain Ropivacaine
n=39 Participants
Plain Ropivacaine 0.75%, (225 mg) total volume 32 cc for interscalene block given pre-operatively
Ropivacaine 0.75%: Only ropivacaine 0.75% is administered for this arm of the interscalene block
|
Ropivacaine + Buprenorphine
n=39 Participants
A mixture of 0.75% ropivacaine with 300 mcg buprenorphine, total volume 32 cc for interscalene block given pre-operatively
Ropivacaine 0.75% + 300 mcg Buprenorphine: Ropivacaine 0.75% + 300 mcg Buprenorphine is administered for this arm of the interscalene block
|
Ropivacaine + Clonidine
n=40 Participants
A mixture of 0.75% ropivacaine with 75 mcg clonidine, total volume 32 cc for interscalene block given pre-operatively
Ropivacaine 0.75% + 75 mcg clonidine: Ropivacaine 0.75% + 75 mcg clonidine is administered for this arm of the interscalene block
|
Ropivacaine + Dexamethasone
n=40 Participants
A mixture of 0.75% ropivacaine with and 8 mg dexamethasone, total volume 32 cc for interscalene block given pre-operatively
Ropivacaine 0.75% + 8 mg dexamethasone: Ropivacaine 0.75% + 8 mg dexamethasone is administered for this arm of the interscalene block
|
|---|---|---|---|---|
|
Number of Patients Reporting Nausea at Home
|
4 Participants
|
9 Participants
|
2 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Post-op day 0 (Baseline)PACU (Post-Anesthesia Care Unit) assessment of nausea
Outcome measures
| Measure |
Plain Ropivacaine
n=40 Participants
Plain Ropivacaine 0.75%, (225 mg) total volume 32 cc for interscalene block given pre-operatively
Ropivacaine 0.75%: Only ropivacaine 0.75% is administered for this arm of the interscalene block
|
Ropivacaine + Buprenorphine
n=40 Participants
A mixture of 0.75% ropivacaine with 300 mcg buprenorphine, total volume 32 cc for interscalene block given pre-operatively
Ropivacaine 0.75% + 300 mcg Buprenorphine: Ropivacaine 0.75% + 300 mcg Buprenorphine is administered for this arm of the interscalene block
|
Ropivacaine + Clonidine
n=40 Participants
A mixture of 0.75% ropivacaine with 75 mcg clonidine, total volume 32 cc for interscalene block given pre-operatively
Ropivacaine 0.75% + 75 mcg clonidine: Ropivacaine 0.75% + 75 mcg clonidine is administered for this arm of the interscalene block
|
Ropivacaine + Dexamethasone
n=40 Participants
A mixture of 0.75% ropivacaine with and 8 mg dexamethasone, total volume 32 cc for interscalene block given pre-operatively
Ropivacaine 0.75% + 8 mg dexamethasone: Ropivacaine 0.75% + 8 mg dexamethasone is administered for this arm of the interscalene block
|
|---|---|---|---|---|
|
Number of Patients Reporting Nausea in the PACU
|
4 Participants
|
9 Participants
|
2 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: Day 1-3Patients are called 1-3 days post-operatively to assess when motor component of their nerve block wore off
Outcome measures
| Measure |
Plain Ropivacaine
n=40 Participants
Plain Ropivacaine 0.75%, (225 mg) total volume 32 cc for interscalene block given pre-operatively
Ropivacaine 0.75%: Only ropivacaine 0.75% is administered for this arm of the interscalene block
|
Ropivacaine + Buprenorphine
n=40 Participants
A mixture of 0.75% ropivacaine with 300 mcg buprenorphine, total volume 32 cc for interscalene block given pre-operatively
Ropivacaine 0.75% + 300 mcg Buprenorphine: Ropivacaine 0.75% + 300 mcg Buprenorphine is administered for this arm of the interscalene block
|
Ropivacaine + Clonidine
n=40 Participants
A mixture of 0.75% ropivacaine with 75 mcg clonidine, total volume 32 cc for interscalene block given pre-operatively
Ropivacaine 0.75% + 75 mcg clonidine: Ropivacaine 0.75% + 75 mcg clonidine is administered for this arm of the interscalene block
|
Ropivacaine + Dexamethasone
n=40 Participants
A mixture of 0.75% ropivacaine with and 8 mg dexamethasone, total volume 32 cc for interscalene block given pre-operatively
Ropivacaine 0.75% + 8 mg dexamethasone: Ropivacaine 0.75% + 8 mg dexamethasone is administered for this arm of the interscalene block
|
|---|---|---|---|---|
|
Motor Duration of Block
|
1120 minutes
Interval 748.0 to 1484.0
|
1198 minutes
Interval 835.0 to 1406.0
|
1090 minutes
Interval 829.0 to 1526.0
|
1143.5 minutes
Interval 949.5 to 1356.5
|
SECONDARY outcome
Timeframe: Post-op Day 0 (baseline)Population: 1 patient in Ropivacaine and Buprenorphine group did get data for the BP changes in the PACU for the study so therefore was not included in the analysis
Blood pressure changes in PACU (Post-Anesthesia Care Unit) for patients was looked at
Outcome measures
| Measure |
Plain Ropivacaine
n=40 Participants
Plain Ropivacaine 0.75%, (225 mg) total volume 32 cc for interscalene block given pre-operatively
Ropivacaine 0.75%: Only ropivacaine 0.75% is administered for this arm of the interscalene block
|
Ropivacaine + Buprenorphine
n=39 Participants
A mixture of 0.75% ropivacaine with 300 mcg buprenorphine, total volume 32 cc for interscalene block given pre-operatively
Ropivacaine 0.75% + 300 mcg Buprenorphine: Ropivacaine 0.75% + 300 mcg Buprenorphine is administered for this arm of the interscalene block
|
Ropivacaine + Clonidine
n=40 Participants
A mixture of 0.75% ropivacaine with 75 mcg clonidine, total volume 32 cc for interscalene block given pre-operatively
Ropivacaine 0.75% + 75 mcg clonidine: Ropivacaine 0.75% + 75 mcg clonidine is administered for this arm of the interscalene block
|
Ropivacaine + Dexamethasone
n=40 Participants
A mixture of 0.75% ropivacaine with and 8 mg dexamethasone, total volume 32 cc for interscalene block given pre-operatively
Ropivacaine 0.75% + 8 mg dexamethasone: Ropivacaine 0.75% + 8 mg dexamethasone is administered for this arm of the interscalene block
|
|---|---|---|---|---|
|
Number of Patients With Blood Pressure (BP) Changes in the PACU
|
8 Participants
|
3 Participants
|
7 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Post-op Day 0 (baseline)Population: 1 patient in Ropivacaine and Buprenorphine group did not have blood pressure data obtained in the second stage area so therefore was not included in the analysis
Blood pressure changes in Second Stage Recovery Area for patients was looked at
Outcome measures
| Measure |
Plain Ropivacaine
n=40 Participants
Plain Ropivacaine 0.75%, (225 mg) total volume 32 cc for interscalene block given pre-operatively
Ropivacaine 0.75%: Only ropivacaine 0.75% is administered for this arm of the interscalene block
|
Ropivacaine + Buprenorphine
n=39 Participants
A mixture of 0.75% ropivacaine with 300 mcg buprenorphine, total volume 32 cc for interscalene block given pre-operatively
Ropivacaine 0.75% + 300 mcg Buprenorphine: Ropivacaine 0.75% + 300 mcg Buprenorphine is administered for this arm of the interscalene block
|
Ropivacaine + Clonidine
n=40 Participants
A mixture of 0.75% ropivacaine with 75 mcg clonidine, total volume 32 cc for interscalene block given pre-operatively
Ropivacaine 0.75% + 75 mcg clonidine: Ropivacaine 0.75% + 75 mcg clonidine is administered for this arm of the interscalene block
|
Ropivacaine + Dexamethasone
n=40 Participants
A mixture of 0.75% ropivacaine with and 8 mg dexamethasone, total volume 32 cc for interscalene block given pre-operatively
Ropivacaine 0.75% + 8 mg dexamethasone: Ropivacaine 0.75% + 8 mg dexamethasone is administered for this arm of the interscalene block
|
|---|---|---|---|---|
|
Number of Patient With Blood Pressure Changes in the Second Stage Recovery Area
|
5 Participants
|
1 Participants
|
5 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 1-3Patients are called 1-3 days post-operatively to assess pain. Pain score is 0-10 scale with 0 is no pain and 10 is most severe pain.
Outcome measures
| Measure |
Plain Ropivacaine
n=40 Participants
Plain Ropivacaine 0.75%, (225 mg) total volume 32 cc for interscalene block given pre-operatively
Ropivacaine 0.75%: Only ropivacaine 0.75% is administered for this arm of the interscalene block
|
Ropivacaine + Buprenorphine
n=40 Participants
A mixture of 0.75% ropivacaine with 300 mcg buprenorphine, total volume 32 cc for interscalene block given pre-operatively
Ropivacaine 0.75% + 300 mcg Buprenorphine: Ropivacaine 0.75% + 300 mcg Buprenorphine is administered for this arm of the interscalene block
|
Ropivacaine + Clonidine
n=40 Participants
A mixture of 0.75% ropivacaine with 75 mcg clonidine, total volume 32 cc for interscalene block given pre-operatively
Ropivacaine 0.75% + 75 mcg clonidine: Ropivacaine 0.75% + 75 mcg clonidine is administered for this arm of the interscalene block
|
Ropivacaine + Dexamethasone
n=40 Participants
A mixture of 0.75% ropivacaine with and 8 mg dexamethasone, total volume 32 cc for interscalene block given pre-operatively
Ropivacaine 0.75% + 8 mg dexamethasone: Ropivacaine 0.75% + 8 mg dexamethasone is administered for this arm of the interscalene block
|
|---|---|---|---|---|
|
Pain Score Reported by Patients at First Phone Call
|
4 units on a scale
Interval 3.0 to 5.0
|
3 units on a scale
Interval 2.0 to 5.0
|
4 units on a scale
Interval 2.0 to 5.5
|
3 units on a scale
Interval 2.0 to 4.5
|
SECONDARY outcome
Timeframe: Post-op day 0 (baseline)Population: 1 patient in the Ropivacaine and Buprenorphine group did not obtain data on the itching in the PACU therefore was not included in the analysis
Patients itching was assessed post-op in the PACU.
Outcome measures
| Measure |
Plain Ropivacaine
n=40 Participants
Plain Ropivacaine 0.75%, (225 mg) total volume 32 cc for interscalene block given pre-operatively
Ropivacaine 0.75%: Only ropivacaine 0.75% is administered for this arm of the interscalene block
|
Ropivacaine + Buprenorphine
n=39 Participants
A mixture of 0.75% ropivacaine with 300 mcg buprenorphine, total volume 32 cc for interscalene block given pre-operatively
Ropivacaine 0.75% + 300 mcg Buprenorphine: Ropivacaine 0.75% + 300 mcg Buprenorphine is administered for this arm of the interscalene block
|
Ropivacaine + Clonidine
n=40 Participants
A mixture of 0.75% ropivacaine with 75 mcg clonidine, total volume 32 cc for interscalene block given pre-operatively
Ropivacaine 0.75% + 75 mcg clonidine: Ropivacaine 0.75% + 75 mcg clonidine is administered for this arm of the interscalene block
|
Ropivacaine + Dexamethasone
n=40 Participants
A mixture of 0.75% ropivacaine with and 8 mg dexamethasone, total volume 32 cc for interscalene block given pre-operatively
Ropivacaine 0.75% + 8 mg dexamethasone: Ropivacaine 0.75% + 8 mg dexamethasone is administered for this arm of the interscalene block
|
|---|---|---|---|---|
|
Number of Patients Reporting Itching in the PACU
|
5 Participants
|
2 Participants
|
6 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: 1-3 daysPatients are called 1-3 days post-operatively to assess if they had any side effects of the adjuvants such as nausea, vomiting or itching. There blood pressure is looked at pre-op and compared to post-op. Any prolonged PACU (Post Anesthesia Care Unit) stay for sedation is recorded.
Outcome measures
| Measure |
Plain Ropivacaine
n=40 Participants
Plain Ropivacaine 0.75%, (225 mg) total volume 32 cc for interscalene block given pre-operatively
Ropivacaine 0.75%: Only ropivacaine 0.75% is administered for this arm of the interscalene block
|
Ropivacaine + Buprenorphine
n=40 Participants
A mixture of 0.75% ropivacaine with 300 mcg buprenorphine, total volume 32 cc for interscalene block given pre-operatively
Ropivacaine 0.75% + 300 mcg Buprenorphine: Ropivacaine 0.75% + 300 mcg Buprenorphine is administered for this arm of the interscalene block
|
Ropivacaine + Clonidine
n=40 Participants
A mixture of 0.75% ropivacaine with 75 mcg clonidine, total volume 32 cc for interscalene block given pre-operatively
Ropivacaine 0.75% + 75 mcg clonidine: Ropivacaine 0.75% + 75 mcg clonidine is administered for this arm of the interscalene block
|
Ropivacaine + Dexamethasone
n=40 Participants
A mixture of 0.75% ropivacaine with and 8 mg dexamethasone, total volume 32 cc for interscalene block given pre-operatively
Ropivacaine 0.75% + 8 mg dexamethasone: Ropivacaine 0.75% + 8 mg dexamethasone is administered for this arm of the interscalene block
|
|---|---|---|---|---|
|
Number of Patients Reporting Itching at Home
|
1 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Post-op Day 0 (Baseline)Surgical position was recorded
Outcome measures
| Measure |
Plain Ropivacaine
n=40 Participants
Plain Ropivacaine 0.75%, (225 mg) total volume 32 cc for interscalene block given pre-operatively
Ropivacaine 0.75%: Only ropivacaine 0.75% is administered for this arm of the interscalene block
|
Ropivacaine + Buprenorphine
n=40 Participants
A mixture of 0.75% ropivacaine with 300 mcg buprenorphine, total volume 32 cc for interscalene block given pre-operatively
Ropivacaine 0.75% + 300 mcg Buprenorphine: Ropivacaine 0.75% + 300 mcg Buprenorphine is administered for this arm of the interscalene block
|
Ropivacaine + Clonidine
n=40 Participants
A mixture of 0.75% ropivacaine with 75 mcg clonidine, total volume 32 cc for interscalene block given pre-operatively
Ropivacaine 0.75% + 75 mcg clonidine: Ropivacaine 0.75% + 75 mcg clonidine is administered for this arm of the interscalene block
|
Ropivacaine + Dexamethasone
n=40 Participants
A mixture of 0.75% ropivacaine with and 8 mg dexamethasone, total volume 32 cc for interscalene block given pre-operatively
Ropivacaine 0.75% + 8 mg dexamethasone: Ropivacaine 0.75% + 8 mg dexamethasone is administered for this arm of the interscalene block
|
|---|---|---|---|---|
|
Surgical Position
Beach Chair
|
38 Participants
|
31 Participants
|
31 Participants
|
32 Participants
|
|
Surgical Position
Lateral
|
2 Participants
|
6 Participants
|
7 Participants
|
6 Participants
|
|
Surgical Position
Supine
|
0 Participants
|
3 Participants
|
2 Participants
|
2 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Post op Day 0 (Baseline)Surgical length was recorded
Outcome measures
| Measure |
Plain Ropivacaine
n=40 Participants
Plain Ropivacaine 0.75%, (225 mg) total volume 32 cc for interscalene block given pre-operatively
Ropivacaine 0.75%: Only ropivacaine 0.75% is administered for this arm of the interscalene block
|
Ropivacaine + Buprenorphine
n=40 Participants
A mixture of 0.75% ropivacaine with 300 mcg buprenorphine, total volume 32 cc for interscalene block given pre-operatively
Ropivacaine 0.75% + 300 mcg Buprenorphine: Ropivacaine 0.75% + 300 mcg Buprenorphine is administered for this arm of the interscalene block
|
Ropivacaine + Clonidine
n=40 Participants
A mixture of 0.75% ropivacaine with 75 mcg clonidine, total volume 32 cc for interscalene block given pre-operatively
Ropivacaine 0.75% + 75 mcg clonidine: Ropivacaine 0.75% + 75 mcg clonidine is administered for this arm of the interscalene block
|
Ropivacaine + Dexamethasone
n=40 Participants
A mixture of 0.75% ropivacaine with and 8 mg dexamethasone, total volume 32 cc for interscalene block given pre-operatively
Ropivacaine 0.75% + 8 mg dexamethasone: Ropivacaine 0.75% + 8 mg dexamethasone is administered for this arm of the interscalene block
|
|---|---|---|---|---|
|
Surgical Length
|
68.5 minutes
Interval 45.0 to 94.0
|
65 minutes
Interval 49.0 to 87.5
|
73.5 minutes
Interval 56.0 to 101.0
|
71 minutes
Interval 47.5 to 117.0
|
Adverse Events
Plain Ropivacaine
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Ropivacaine + Buprenorphine
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Ropivacaine + Clonidine
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Ropivacaine + Dexamethasone
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