Trial Outcomes & Findings for The Effects of Dexamethasone on Low Dose Interscalene Brachial Plexus Block (NCT NCT02322242)
NCT ID: NCT02322242
Last Updated: 2020-07-15
Results Overview
Defined as time from completion of block procedure to NRS for pain \> 0 (in hours)
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
182 participants
Primary outcome timeframe
1 day postoperative
Results posted on
2020-07-15
Participant Flow
Recruitment setting: pre-operative anesthesia clinic 182 recruited because of time lag between recruitment and surgery
Participant milestones
| Measure |
Perineural Dexamethasone
ISB performed with local anesthetic (ropivacaine 0.5%) and perinerual dexamethasone (4mg)
|
Systemic Dexamethasone
ISB with local anesthetic alone (ropivacaine 0.5%) alone and intravenous dexamethasone (4mg)
|
|---|---|---|
|
Overall Study
STARTED
|
92
|
90
|
|
Overall Study
Primary Outcome
|
92
|
90
|
|
Overall Study
1 Week Follow-up
|
90
|
89
|
|
Overall Study
COMPLETED
|
92
|
90
|
|
Overall Study
NOT COMPLETED
|
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 |
Perineural Dexamethasone
n=92 Participants
ISB performed with local anesthetic (ropivacaine 0.5%) and perinerual dexamethasone (4mg)
Perineural dexamethasone: Perinerual administration of dexamethasone (4mg)
|
Systemic Dexamethasone
n=90 Participants
ISB with local anesthetic alone (ropivacaine 0.5%) alone and intravenous dexamethasone (4mg)
Systemic Dexamethasone: Intravenous infusion of dexamethasone (4mg)
|
Total
n=182 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
51.6 years
n=92 Participants
|
52.8 years
n=90 Participants
|
52.2 years
n=182 Participants
|
|
Sex: Female, Male
Female
|
25 Participants
n=92 Participants
|
21 Participants
n=90 Participants
|
46 Participants
n=182 Participants
|
|
Sex: Female, Male
Male
|
67 Participants
n=92 Participants
|
69 Participants
n=90 Participants
|
136 Participants
n=182 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
PRIMARY outcome
Timeframe: 1 day postoperativeDefined as time from completion of block procedure to NRS for pain \> 0 (in hours)
Outcome measures
| Measure |
Perineural Dexamethasone
n=92 Participants
ISB performed with local anesthetic (ropivacaine 0.5%) and perinerual dexamethasone (4mg)
|
Systemic Dexamethasone
n=90 Participants
ISB with local anesthetic alone (ropivacaine 0.5%) alone and intravenous dexamethasone (4mg)
|
|---|---|---|
|
Duration of Sensory Block
|
521 minutes
Standard Deviation 442
|
566 minutes
Standard Deviation 428
|
SECONDARY outcome
Timeframe: 1 day postoperativeDefined as time from completion of block procedure to first consumption of opioid analgesic (in hours)
Outcome measures
| Measure |
Perineural Dexamethasone
n=92 Participants
ISB performed with local anesthetic (ropivacaine 0.5%) and perinerual dexamethasone (4mg)
|
Systemic Dexamethasone
n=90 Participants
ISB with local anesthetic alone (ropivacaine 0.5%) alone and intravenous dexamethasone (4mg)
|
|---|---|---|
|
Time to First Opioid Consumption
|
9.1 hours
Standard Deviation 6.9
|
9.6 hours
Standard Deviation 10.8
|
SECONDARY outcome
Timeframe: 1 day postoperativeDefined as time from completion of block procedure to return to baseline motor function (in hours)
Outcome measures
| Measure |
Perineural Dexamethasone
n=92 Participants
ISB performed with local anesthetic (ropivacaine 0.5%) and perinerual dexamethasone (4mg)
|
Systemic Dexamethasone
n=90 Participants
ISB with local anesthetic alone (ropivacaine 0.5%) alone and intravenous dexamethasone (4mg)
|
|---|---|---|
|
Duration of Motor Block
|
18.5 hours
Standard Deviation 13.8
|
20.3 hours
Standard Deviation 22.3
|
SECONDARY outcome
Timeframe: 1 hour postoperativePulse oximetry (in %) measured 1 hour after arrival in post-operative recovery room, scale 0-100, higher number is better
Outcome measures
| Measure |
Perineural Dexamethasone
n=92 Participants
ISB performed with local anesthetic (ropivacaine 0.5%) and perinerual dexamethasone (4mg)
|
Systemic Dexamethasone
n=90 Participants
ISB with local anesthetic alone (ropivacaine 0.5%) alone and intravenous dexamethasone (4mg)
|
|---|---|---|
|
Post-operative Oxygen Saturation on Room Air
|
96.6 Room air oxygen saturation percent
Standard Deviation 2.3
|
97.0 Room air oxygen saturation percent
Standard Deviation 2.4
|
SECONDARY outcome
Timeframe: 7 days postoperativeOpioid consumption (in oral morphine equivalents) will be recorded at 12 hours, 24 hours, and 7 days
Outcome measures
| Measure |
Perineural Dexamethasone
n=92 Participants
ISB performed with local anesthetic (ropivacaine 0.5%) and perinerual dexamethasone (4mg)
|
Systemic Dexamethasone
n=90 Participants
ISB with local anesthetic alone (ropivacaine 0.5%) alone and intravenous dexamethasone (4mg)
|
|---|---|---|
|
Opioid Consumption
|
148.8 mg (oral morphine equivalent)
Standard Deviation 117.9
|
167.2 mg (oral morphine equivalent)
Standard Deviation 140.0
|
SECONDARY outcome
Timeframe: 7 days postoperativeRecorded at 12 hours, 24 hours, and 7 days 0 is no pain, 10 is the worst pain imaginable. Lower number is better.
Outcome measures
| Measure |
Perineural Dexamethasone
n=92 Participants
ISB performed with local anesthetic (ropivacaine 0.5%) and perinerual dexamethasone (4mg)
|
Systemic Dexamethasone
n=90 Participants
ISB with local anesthetic alone (ropivacaine 0.5%) alone and intravenous dexamethasone (4mg)
|
|---|---|---|
|
Numeric Rating Scale for Pain (NRS 0-10)
7 days
|
3.1 units on a scale
Standard Deviation 2.3
|
3.4 units on a scale
Standard Deviation 2.4
|
|
Numeric Rating Scale for Pain (NRS 0-10)
24hours
|
4.9 units on a scale
Standard Deviation 2.6
|
4.7 units on a scale
Standard Deviation 2.6
|
|
Numeric Rating Scale for Pain (NRS 0-10)
12hours
|
3.3 units on a scale
Standard Deviation 3.0
|
3.3 units on a scale
Standard Deviation 2.9
|
SECONDARY outcome
Timeframe: 1 hour postoperativeMeasured 1 hour after arrival to the post-operative recovery room
Outcome measures
| Measure |
Perineural Dexamethasone
n=92 Participants
ISB performed with local anesthetic (ropivacaine 0.5%) and perinerual dexamethasone (4mg)
|
Systemic Dexamethasone
n=90 Participants
ISB with local anesthetic alone (ropivacaine 0.5%) alone and intravenous dexamethasone (4mg)
|
|---|---|---|
|
Postoperative Serum Blood Glucose
|
6.8 mmol/L
Standard Deviation 1.0
|
6.6 mmol/L
Standard Deviation 1.1
|
SECONDARY outcome
Timeframe: 7 Days postoperativeDefined as persistent paresthesia, and sensory/motor block at 7 days
Outcome measures
| Measure |
Perineural Dexamethasone
n=92 Participants
ISB performed with local anesthetic (ropivacaine 0.5%) and perinerual dexamethasone (4mg)
|
Systemic Dexamethasone
n=90 Participants
ISB with local anesthetic alone (ropivacaine 0.5%) alone and intravenous dexamethasone (4mg)
|
|---|---|---|
|
Number of Participants With Nerve Damage From Interscalene Block
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 7 Days postoperativeNumber of participants with localized infection at nerve block site
Outcome measures
| Measure |
Perineural Dexamethasone
n=92 Participants
ISB performed with local anesthetic (ropivacaine 0.5%) and perinerual dexamethasone (4mg)
|
Systemic Dexamethasone
n=90 Participants
ISB with local anesthetic alone (ropivacaine 0.5%) alone and intravenous dexamethasone (4mg)
|
|---|---|---|
|
Infection
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 7 days postoperativeNumber of participants with postoperative nausea and/or vomiting assessed at 12 hours, 24, hours, and 7 days postoperatively
Outcome measures
| Measure |
Perineural Dexamethasone
n=92 Participants
ISB performed with local anesthetic (ropivacaine 0.5%) and perinerual dexamethasone (4mg)
|
Systemic Dexamethasone
n=90 Participants
ISB with local anesthetic alone (ropivacaine 0.5%) alone and intravenous dexamethasone (4mg)
|
|---|---|---|
|
Number of Participants With Postoperative Nausea and/or Vomiting
|
32 Participants
|
32 Participants
|
Adverse Events
Perineural Dexamethasone
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Systemic 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