Trial Outcomes & Findings for the Analgesic Duration of Dexmedetomidine Compared to Dexamethasone as Adjuncts to Single Shot Interscalene Block (NCT NCT02653144)
NCT ID: NCT02653144
Last Updated: 2020-07-22
Results Overview
How much opioid did patient ask for within 24 hours post op
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
105 participants
Primary outcome timeframe
24 hours
Results posted on
2020-07-22
Participant Flow
Participant milestones
| Measure |
Dexmedetomidine and Ropivacaine Group
In this group, participants will undergo pre-operative single shot interscalene nerve block under ultrasound guidance and peripheral nerve stimulation with Ropivacaine 0.5% 20ml + 75mcg of dexmedetomidine
Ropivacaine: local anesthetics adjuvants. Ropivacaine 0.5% 20ml. pre-operative single shot interscalene nerve block under ultrasound guidance and peripheral nerve stimulation in patients undergoing ambulatory shoulder surgery
Dexmedetomidine: local anesthetics adjuvants. 75mcg of dexmedetomidine. pre-operative single shot interscalene nerve block under ultrasound guidance and peripheral nerve stimulation in patients undergoing ambulatory shoulder surgery
|
Dexamethasone and Ropivacaine Group
In this group, participants will undergo pre-operative single shot interscalene nerve block under ultrasound guidance and peripheral nerve stimulation with. Ropivacaine 0.5% 20ml + 4mg dexamethasone
Ropivacaine: local anesthetics adjuvants. Ropivacaine 0.5% 20ml. pre-operative single shot interscalene nerve block under ultrasound guidance and peripheral nerve stimulation in patients undergoing ambulatory shoulder surgery
Dexamethasone: local anesthetics adjuvants. 4mg dexamethasone. pre-operative single shot interscalene nerve block under ultrasound guidance and peripheral nerve stimulation in patients undergoing ambulatory shoulder surgery
|
Ropivacaine Only Group
In this group, participants will undergo pre-operative single shot interscalene nerve block under ultrasound guidance and peripheral nerve stimulation with Ropivacaine 0.5% 20ml (acting as control)
Ropivacaine: local anesthetics adjuvants. Ropivacaine 0.5% 20ml. pre-operative single shot interscalene nerve block under ultrasound guidance and peripheral nerve stimulation in patients undergoing ambulatory shoulder surgery
|
|---|---|---|---|
|
Overall Study
STARTED
|
30
|
28
|
31
|
|
Overall Study
COMPLETED
|
30
|
28
|
31
|
|
Overall Study
NOT COMPLETED
|
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 |
Dexmedetomidine and Ropivacaine Group
n=30 Participants
In this group, participants will undergo pre-operative single shot interscalene nerve block under ultrasound guidance and peripheral nerve stimulation with Ropivacaine 0.5% 20ml + 75mcg of dexmedetomidine
Ropivacaine: local anesthetics adjuvants. Ropivacaine 0.5% 20ml. pre-operative single shot interscalene nerve block under ultrasound guidance and peripheral nerve stimulation in patients undergoing ambulatory shoulder surgery
Dexmedetomidine: local anesthetics adjuvants. 75mcg of dexmedetomidine. pre-operative single shot interscalene nerve block under ultrasound guidance and peripheral nerve stimulation in patients undergoing ambulatory shoulder surgery
|
Dexamethasone and Ropivacaine Group
n=28 Participants
In this group, participants will undergo pre-operative single shot interscalene nerve block under ultrasound guidance and peripheral nerve stimulation with. Ropivacaine 0.5% 20ml + 4mg dexamethasone
Ropivacaine: local anesthetics adjuvants. Ropivacaine 0.5% 20ml. pre-operative single shot interscalene nerve block under ultrasound guidance and peripheral nerve stimulation in patients undergoing ambulatory shoulder surgery
Dexamethasone: local anesthetics adjuvants. 4mg dexamethasone. pre-operative single shot interscalene nerve block under ultrasound guidance and peripheral nerve stimulation in patients undergoing ambulatory shoulder surgery
|
Ropivacaine Only Group
n=31 Participants
In this group, participants will undergo pre-operative single shot interscalene nerve block under ultrasound guidance and peripheral nerve stimulation with Ropivacaine 0.5% 20ml (acting as control)
Ropivacaine: local anesthetics adjuvants. Ropivacaine 0.5% 20ml. pre-operative single shot interscalene nerve block under ultrasound guidance and peripheral nerve stimulation in patients undergoing ambulatory shoulder surgery
|
Total
n=89 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
54 years
n=30 Participants
|
52 years
n=28 Participants
|
52 years
n=31 Participants
|
53.5 years
n=89 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=30 Participants
|
14 Participants
n=28 Participants
|
12 Participants
n=31 Participants
|
44 Participants
n=89 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=30 Participants
|
14 Participants
n=28 Participants
|
19 Participants
n=31 Participants
|
45 Participants
n=89 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Body Mass Index
|
31 kg/m2
n=30 Participants
|
29 kg/m2
n=28 Participants
|
29 kg/m2
n=31 Participants
|
29 kg/m2
n=89 Participants
|
PRIMARY outcome
Timeframe: 24 hoursHow much opioid did patient ask for within 24 hours post op
Outcome measures
| Measure |
Dexmedetomidine and Ropivacaine Group
n=30 Participants
In this group, participants will undergo pre-operative single shot interscalene nerve block under ultrasound guidance and peripheral nerve stimulation with Ropivacaine 0.5% 20ml + 75mcg of dexmedetomidine
Ropivacaine: local anesthetics adjuvants. Ropivacaine 0.5% 20ml. pre-operative single shot interscalene nerve block under ultrasound guidance and peripheral nerve stimulation in patients undergoing ambulatory shoulder surgery
Dexmedetomidine: local anesthetics adjuvants. 75mcg of dexmedetomidine. pre-operative single shot interscalene nerve block under ultrasound guidance and peripheral nerve stimulation in patients undergoing ambulatory shoulder surgery
|
Dexamethasone and Ropivacaine Group
n=28 Participants
In this group, participants will undergo pre-operative single shot interscalene nerve block under ultrasound guidance and peripheral nerve stimulation with. Ropivacaine 0.5% 20ml + 4mg dexamethasone
Ropivacaine: local anesthetics adjuvants. Ropivacaine 0.5% 20ml. pre-operative single shot interscalene nerve block under ultrasound guidance and peripheral nerve stimulation in patients undergoing ambulatory shoulder surgery
Dexamethasone: local anesthetics adjuvants. 4mg dexamethasone. pre-operative single shot interscalene nerve block under ultrasound guidance and peripheral nerve stimulation in patients undergoing ambulatory shoulder surgery
|
Ropivacaine Only Group
n=31 Participants
In this group, participants will undergo pre-operative single shot interscalene nerve block under ultrasound guidance and peripheral nerve stimulation with Ropivacaine 0.5% 20ml (acting as control)
Ropivacaine: local anesthetics adjuvants. Ropivacaine 0.5% 20ml. pre-operative single shot interscalene nerve block under ultrasound guidance and peripheral nerve stimulation in patients undergoing ambulatory shoulder surgery
|
|---|---|---|---|
|
Opioid Requirements (Morphine Equivalents)
|
15 morphine milligram equivalent
Interval 0.0 to 30.0
|
15 morphine milligram equivalent
Interval 0.0 to 20.6
|
22.5 morphine milligram equivalent
Interval 10.0 to 30.0
|
SECONDARY outcome
Timeframe: 48 hoursHow much opioid did patient ask for within 48 hours post op
Outcome measures
| Measure |
Dexmedetomidine and Ropivacaine Group
n=30 Participants
In this group, participants will undergo pre-operative single shot interscalene nerve block under ultrasound guidance and peripheral nerve stimulation with Ropivacaine 0.5% 20ml + 75mcg of dexmedetomidine
Ropivacaine: local anesthetics adjuvants. Ropivacaine 0.5% 20ml. pre-operative single shot interscalene nerve block under ultrasound guidance and peripheral nerve stimulation in patients undergoing ambulatory shoulder surgery
Dexmedetomidine: local anesthetics adjuvants. 75mcg of dexmedetomidine. pre-operative single shot interscalene nerve block under ultrasound guidance and peripheral nerve stimulation in patients undergoing ambulatory shoulder surgery
|
Dexamethasone and Ropivacaine Group
n=28 Participants
In this group, participants will undergo pre-operative single shot interscalene nerve block under ultrasound guidance and peripheral nerve stimulation with. Ropivacaine 0.5% 20ml + 4mg dexamethasone
Ropivacaine: local anesthetics adjuvants. Ropivacaine 0.5% 20ml. pre-operative single shot interscalene nerve block under ultrasound guidance and peripheral nerve stimulation in patients undergoing ambulatory shoulder surgery
Dexamethasone: local anesthetics adjuvants. 4mg dexamethasone. pre-operative single shot interscalene nerve block under ultrasound guidance and peripheral nerve stimulation in patients undergoing ambulatory shoulder surgery
|
Ropivacaine Only Group
n=31 Participants
In this group, participants will undergo pre-operative single shot interscalene nerve block under ultrasound guidance and peripheral nerve stimulation with Ropivacaine 0.5% 20ml (acting as control)
Ropivacaine: local anesthetics adjuvants. Ropivacaine 0.5% 20ml. pre-operative single shot interscalene nerve block under ultrasound guidance and peripheral nerve stimulation in patients undergoing ambulatory shoulder surgery
|
|---|---|---|---|
|
Opioid Requirements (Morphine Equivalents)
|
52.5 morphine milligram equivalent
Interval 30.0 to 75.0
|
30 morphine milligram equivalent
Interval 22.0 to 50.6
|
40 morphine milligram equivalent
Interval 25.0 to 67.5
|
SECONDARY outcome
Timeframe: 24-48 hours after surgeryHow long after surgery does patient take to ask for opioid to manage pain
Outcome measures
| Measure |
Dexmedetomidine and Ropivacaine Group
n=30 Participants
In this group, participants will undergo pre-operative single shot interscalene nerve block under ultrasound guidance and peripheral nerve stimulation with Ropivacaine 0.5% 20ml + 75mcg of dexmedetomidine
Ropivacaine: local anesthetics adjuvants. Ropivacaine 0.5% 20ml. pre-operative single shot interscalene nerve block under ultrasound guidance and peripheral nerve stimulation in patients undergoing ambulatory shoulder surgery
Dexmedetomidine: local anesthetics adjuvants. 75mcg of dexmedetomidine. pre-operative single shot interscalene nerve block under ultrasound guidance and peripheral nerve stimulation in patients undergoing ambulatory shoulder surgery
|
Dexamethasone and Ropivacaine Group
n=28 Participants
In this group, participants will undergo pre-operative single shot interscalene nerve block under ultrasound guidance and peripheral nerve stimulation with. Ropivacaine 0.5% 20ml + 4mg dexamethasone
Ropivacaine: local anesthetics adjuvants. Ropivacaine 0.5% 20ml. pre-operative single shot interscalene nerve block under ultrasound guidance and peripheral nerve stimulation in patients undergoing ambulatory shoulder surgery
Dexamethasone: local anesthetics adjuvants. 4mg dexamethasone. pre-operative single shot interscalene nerve block under ultrasound guidance and peripheral nerve stimulation in patients undergoing ambulatory shoulder surgery
|
Ropivacaine Only Group
n=31 Participants
In this group, participants will undergo pre-operative single shot interscalene nerve block under ultrasound guidance and peripheral nerve stimulation with Ropivacaine 0.5% 20ml (acting as control)
Ropivacaine: local anesthetics adjuvants. Ropivacaine 0.5% 20ml. pre-operative single shot interscalene nerve block under ultrasound guidance and peripheral nerve stimulation in patients undergoing ambulatory shoulder surgery
|
|---|---|---|---|
|
Time to Discharge From PACU to First Opioid Consumption
|
1280 minutes
Interval 977.0 to 1434.0
|
1130 minutes
Interval 854.0 to 1325.0
|
900 minutes
Interval 609.0 to 1348.0
|
SECONDARY outcome
Timeframe: 24-48 hours after surgeryBetween 24 to 48 hours after surgery, questionnaire will be used to determine if motor and sensory function have returned.
Outcome measures
| Measure |
Dexmedetomidine and Ropivacaine Group
n=30 Participants
In this group, participants will undergo pre-operative single shot interscalene nerve block under ultrasound guidance and peripheral nerve stimulation with Ropivacaine 0.5% 20ml + 75mcg of dexmedetomidine
Ropivacaine: local anesthetics adjuvants. Ropivacaine 0.5% 20ml. pre-operative single shot interscalene nerve block under ultrasound guidance and peripheral nerve stimulation in patients undergoing ambulatory shoulder surgery
Dexmedetomidine: local anesthetics adjuvants. 75mcg of dexmedetomidine. pre-operative single shot interscalene nerve block under ultrasound guidance and peripheral nerve stimulation in patients undergoing ambulatory shoulder surgery
|
Dexamethasone and Ropivacaine Group
n=28 Participants
In this group, participants will undergo pre-operative single shot interscalene nerve block under ultrasound guidance and peripheral nerve stimulation with. Ropivacaine 0.5% 20ml + 4mg dexamethasone
Ropivacaine: local anesthetics adjuvants. Ropivacaine 0.5% 20ml. pre-operative single shot interscalene nerve block under ultrasound guidance and peripheral nerve stimulation in patients undergoing ambulatory shoulder surgery
Dexamethasone: local anesthetics adjuvants. 4mg dexamethasone. pre-operative single shot interscalene nerve block under ultrasound guidance and peripheral nerve stimulation in patients undergoing ambulatory shoulder surgery
|
Ropivacaine Only Group
n=31 Participants
In this group, participants will undergo pre-operative single shot interscalene nerve block under ultrasound guidance and peripheral nerve stimulation with Ropivacaine 0.5% 20ml (acting as control)
Ropivacaine: local anesthetics adjuvants. Ropivacaine 0.5% 20ml. pre-operative single shot interscalene nerve block under ultrasound guidance and peripheral nerve stimulation in patients undergoing ambulatory shoulder surgery
|
|---|---|---|---|
|
Return of Motor and Sensory Function
|
1280 minutes
Interval 977.0 to 1434.0
|
1130 minutes
Interval 854.0 to 1325.0
|
900 minutes
Interval 609.0 to 1348.0
|
Adverse Events
Dexmedetomidine and Ropivacaine Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Dexamethasone and Ropivacaine Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Ropivacaine Only Group
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