Trial Outcomes & Findings for Decadron as Adjuvant in Femoral Nerve Blocks in Knee Arthroscopy (NCT NCT01971645)
NCT ID: NCT01971645
Last Updated: 2018-12-11
Results Overview
Number of doses of narcotic pain medicine administered during surgery and up to 48 hours after discharge from surgery center.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
77 participants
Primary outcome timeframe
Intra-operative and up to 48 hours post-discharge, an average of 48 hours
Results posted on
2018-12-11
Participant Flow
Participant milestones
| Measure |
Perineural Dexamethasone Group
Perineural group patients will receive 2 mg/kg of 0.5% ropivacaine (max. dose 100 mg) with 0.1 mg/kg preservative-free dexamethasone (max. dose 4 mg) perineurally for their femoral block. Group D will also receive a gluteal intramuscular injection of saline of volume equivalent to 0.1 mg/kg preservative-free dexamethasone (max. volume 0.4 ml).
Dexamethasone: Patients may receive 0.1 mg/kg preservative-free dexamethasone (max. dose 4 mg) either perineurally or intramuscularly.
Ropivacaine: Patients will receive 2 mg/kg of 0.5% ropivacaine (max. dose 100 mg) perineurally.
|
Ropivacaine Group
Ropivacaine group patients will receive 2 mg/kg of 0.5% ropivacaine (max. dose 100 mg) combined with a volume of saline equivalent to 0.1 mg/kg preservative-free dexamethasone (max. volume 0.4 ml) perineurally. Group R will also receive a gluteal intramuscular injection of saline of volume equivalent to 0.1 mg/kg preservative-free dexamethasone (max. volume 0.4 ml).
Ropivacaine: Patients will receive 2 mg/kg of 0.5% ropivacaine (max. dose 100 mg) perineurally.
|
Intramuscular Dexamethasone Group
Intramuscular group patients will receive 2 mg/kg of 0.5% ropivacaine (max. dose 100 mg) combined with a volume of saline equivalent to 0.1 mg/kg preservative-free dexamethasone (max. volume 0.4 ml) perineurally. Group M will also receive a gluteal intramuscular injection of 0.1 mg/kg preservative-free dexamethasone (max. dose 4 mg).
Dexamethasone: Patients may receive 0.1 mg/kg preservative-free dexamethasone (max. dose 4 mg) either perineurally or intramuscularly.
Ropivacaine: Patients will receive 2 mg/kg of 0.5% ropivacaine (max. dose 100 mg) perineurally.
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|---|---|---|---|
|
Overall Study
STARTED
|
25
|
27
|
25
|
|
Overall Study
COMPLETED
|
23
|
27
|
23
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
2
|
Reasons for withdrawal
| Measure |
Perineural Dexamethasone Group
Perineural group patients will receive 2 mg/kg of 0.5% ropivacaine (max. dose 100 mg) with 0.1 mg/kg preservative-free dexamethasone (max. dose 4 mg) perineurally for their femoral block. Group D will also receive a gluteal intramuscular injection of saline of volume equivalent to 0.1 mg/kg preservative-free dexamethasone (max. volume 0.4 ml).
Dexamethasone: Patients may receive 0.1 mg/kg preservative-free dexamethasone (max. dose 4 mg) either perineurally or intramuscularly.
Ropivacaine: Patients will receive 2 mg/kg of 0.5% ropivacaine (max. dose 100 mg) perineurally.
|
Ropivacaine Group
Ropivacaine group patients will receive 2 mg/kg of 0.5% ropivacaine (max. dose 100 mg) combined with a volume of saline equivalent to 0.1 mg/kg preservative-free dexamethasone (max. volume 0.4 ml) perineurally. Group R will also receive a gluteal intramuscular injection of saline of volume equivalent to 0.1 mg/kg preservative-free dexamethasone (max. volume 0.4 ml).
Ropivacaine: Patients will receive 2 mg/kg of 0.5% ropivacaine (max. dose 100 mg) perineurally.
|
Intramuscular Dexamethasone Group
Intramuscular group patients will receive 2 mg/kg of 0.5% ropivacaine (max. dose 100 mg) combined with a volume of saline equivalent to 0.1 mg/kg preservative-free dexamethasone (max. volume 0.4 ml) perineurally. Group M will also receive a gluteal intramuscular injection of 0.1 mg/kg preservative-free dexamethasone (max. dose 4 mg).
Dexamethasone: Patients may receive 0.1 mg/kg preservative-free dexamethasone (max. dose 4 mg) either perineurally or intramuscularly.
Ropivacaine: Patients will receive 2 mg/kg of 0.5% ropivacaine (max. dose 100 mg) perineurally.
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
1
|
|
Overall Study
Protocol Violation
|
0
|
0
|
1
|
Baseline Characteristics
Decadron as Adjuvant in Femoral Nerve Blocks in Knee Arthroscopy
Baseline characteristics by cohort
| Measure |
Perineural Dexamethasone Group
n=25 Participants
Group D patients will receive 2 mg/kg of 0.5% ropivacaine (max. dose 100 mg) with 0.1 mg/kg preservative-free dexamethasone (max. dose 4 mg) perineurally for their femoral block. Group D will also receive a gluteal intramuscular injection of saline of volume equivalent to 0.1 mg/kg preservative-free dexamethasone (max. volume 0.4 ml).
Dexamethasone: Patients may receive 0.1 mg/kg preservative-free dexamethasone (max. dose 4 mg) either perineurally or intramuscularly.
Ropivacaine: Patients will receive 2 mg/kg of 0.5% ropivacaine (max. dose 100 mg) perineurally.
|
Ropivacaine Group
n=27 Participants
Group R patients will receive 2 mg/kg of 0.5% ropivacaine (max. dose 100 mg) combined with a volume of saline equivalent to 0.1 mg/kg preservative-free dexamethasone (max. volume 0.4 ml) perineurally. Group R will also receive a gluteal intramuscular injection of saline of volume equivalent to 0.1 mg/kg preservative-free dexamethasone (max. volume 0.4 ml).
Ropivacaine: Patients will receive 2 mg/kg of 0.5% ropivacaine (max. dose 100 mg) perineurally.
|
Intramuscular Dexamethasone Group
n=25 Participants
Group M patients will receive 2 mg/kg of 0.5% ropivacaine (max. dose 100 mg) combined with a volume of saline equivalent to 0.1 mg/kg preservative-free dexamethasone (max. volume 0.4 ml) perineurally. Group M will also receive a gluteal intramuscular injection of 0.1 mg/kg preservative-free dexamethasone (max. dose 4 mg).
Dexamethasone: Patients may receive 0.1 mg/kg preservative-free dexamethasone (max. dose 4 mg) either perineurally or intramuscularly.
Ropivacaine: Patients will receive 2 mg/kg of 0.5% ropivacaine (max. dose 100 mg) perineurally.
|
Total
n=77 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
24 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
74 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Continuous
|
15.1 years
STANDARD_DEVIATION 2 • n=5 Participants
|
14.6 years
STANDARD_DEVIATION 2 • n=7 Participants
|
14.7 years
STANDARD_DEVIATION 2 • n=5 Participants
|
14.8 years
STANDARD_DEVIATION 2 • n=4 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
41 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
36 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
25 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
77 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Intra-operative and up to 48 hours post-discharge, an average of 48 hoursNumber of doses of narcotic pain medicine administered during surgery and up to 48 hours after discharge from surgery center.
Outcome measures
| Measure |
Group D
n=23 Participants
Group D patients will receive 2 mg/kg of 0.5% ropivacaine (max. dose 100 mg) with 0.1 mg/kg preservative-free dexamethasone (max. dose 4 mg) perineurally for their femoral block. Group D will also receive a gluteal intramuscular injection of saline of volume equivalent to 0.1 mg/kg preservative-free dexamethasone (max. volume 0.4 ml).
Dexamethasone: Patients may receive 0.1 mg/kg preservative-free dexamethasone (max. dose 4 mg) either perineurally or intramuscularly.
Ropivacaine: Patients will receive 2 mg/kg of 0.5% ropivacaine (max. dose 100 mg) perineurally.
|
Group R
n=27 Participants
Group R patients will receive 2 mg/kg of 0.5% ropivacaine (max. dose 100 mg) combined with a volume of saline equivalent to 0.1 mg/kg preservative-free dexamethasone (max. volume 0.4 ml) perineurally. Group R will also receive a gluteal intramuscular injection of saline of volume equivalent to 0.1 mg/kg preservative-free dexamethasone (max. volume 0.4 ml).
Ropivacaine: Patients will receive 2 mg/kg of 0.5% ropivacaine (max. dose 100 mg) perineurally.
|
Group M
n=23 Participants
Group M patients will receive 2 mg/kg of 0.5% ropivacaine (max. dose 100 mg) combined with a volume of saline equivalent to 0.1 mg/kg preservative-free dexamethasone (max. volume 0.4 ml) perineurally. Group M will also receive a gluteal intramuscular injection of 0.1 mg/kg preservative-free dexamethasone (max. dose 4 mg).
Dexamethasone: Patients may receive 0.1 mg/kg preservative-free dexamethasone (max. dose 4 mg) either perineurally or intramuscularly.
Ropivacaine: Patients will receive 2 mg/kg of 0.5% ropivacaine (max. dose 100 mg) perineurally.
|
|---|---|---|---|
|
Intra-operative and Post-operative Opioid Consumption
|
2 doses
Interval 1.0 to 4.0
|
2 doses
Interval 0.0 to 5.0
|
3 doses
Interval 0.0 to 6.0
|
SECONDARY outcome
Timeframe: Immediately post-operatively and up to 48 hours post-discharge, an average of 48 hoursVisual Analogue Scale (VAS) pain scores (0 being no pain and 10 being worst pain) from arrival to post-anesthesia care unit (PACU) to 48 hours after discharge from surgery center.
Outcome measures
| Measure |
Group D
n=23 Participants
Group D patients will receive 2 mg/kg of 0.5% ropivacaine (max. dose 100 mg) with 0.1 mg/kg preservative-free dexamethasone (max. dose 4 mg) perineurally for their femoral block. Group D will also receive a gluteal intramuscular injection of saline of volume equivalent to 0.1 mg/kg preservative-free dexamethasone (max. volume 0.4 ml).
Dexamethasone: Patients may receive 0.1 mg/kg preservative-free dexamethasone (max. dose 4 mg) either perineurally or intramuscularly.
Ropivacaine: Patients will receive 2 mg/kg of 0.5% ropivacaine (max. dose 100 mg) perineurally.
|
Group R
n=27 Participants
Group R patients will receive 2 mg/kg of 0.5% ropivacaine (max. dose 100 mg) combined with a volume of saline equivalent to 0.1 mg/kg preservative-free dexamethasone (max. volume 0.4 ml) perineurally. Group R will also receive a gluteal intramuscular injection of saline of volume equivalent to 0.1 mg/kg preservative-free dexamethasone (max. volume 0.4 ml).
Ropivacaine: Patients will receive 2 mg/kg of 0.5% ropivacaine (max. dose 100 mg) perineurally.
|
Group M
n=23 Participants
Group M patients will receive 2 mg/kg of 0.5% ropivacaine (max. dose 100 mg) combined with a volume of saline equivalent to 0.1 mg/kg preservative-free dexamethasone (max. volume 0.4 ml) perineurally. Group M will also receive a gluteal intramuscular injection of 0.1 mg/kg preservative-free dexamethasone (max. dose 4 mg).
Dexamethasone: Patients may receive 0.1 mg/kg preservative-free dexamethasone (max. dose 4 mg) either perineurally or intramuscularly.
Ropivacaine: Patients will receive 2 mg/kg of 0.5% ropivacaine (max. dose 100 mg) perineurally.
|
|---|---|---|---|
|
Post-operative Pain Scores
|
2 units on a scale
Interval 0.0 to 4.0
|
2 units on a scale
Interval 0.0 to 2.0
|
1 units on a scale
Interval 0.0 to 3.0
|
Adverse Events
Group D
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Group R
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Group M
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Group D
n=25 participants at risk
Group D patients will receive 2 mg/kg of 0.5% ropivacaine (max. dose 100 mg) with 0.1 mg/kg preservative-free dexamethasone (max. dose 4 mg) perineurally for their femoral block. Group D will also receive a gluteal intramuscular injection of saline of volume equivalent to 0.1 mg/kg preservative-free dexamethasone (max. volume 0.4 ml).
Dexamethasone: Patients may receive 0.1 mg/kg preservative-free dexamethasone (max. dose 4 mg) either perineurally or intramuscularly.
Ropivacaine: Patients will receive 2 mg/kg of 0.5% ropivacaine (max. dose 100 mg) perineurally.
|
Group R
n=27 participants at risk
Group R patients will receive 2 mg/kg of 0.5% ropivacaine (max. dose 100 mg) combined with a volume of saline equivalent to 0.1 mg/kg preservative-free dexamethasone (max. volume 0.4 ml) perineurally. Group R will also receive a gluteal intramuscular injection of saline of volume equivalent to 0.1 mg/kg preservative-free dexamethasone (max. volume 0.4 ml).
Ropivacaine: Patients will receive 2 mg/kg of 0.5% ropivacaine (max. dose 100 mg) perineurally.
|
Group M
n=25 participants at risk
Group M patients will receive 2 mg/kg of 0.5% ropivacaine (max. dose 100 mg) combined with a volume of saline equivalent to 0.1 mg/kg preservative-free dexamethasone (max. volume 0.4 ml) perineurally. Group M will also receive a gluteal intramuscular injection of 0.1 mg/kg preservative-free dexamethasone (max. dose 4 mg).
Dexamethasone: Patients may receive 0.1 mg/kg preservative-free dexamethasone (max. dose 4 mg) either perineurally or intramuscularly.
Ropivacaine: Patients will receive 2 mg/kg of 0.5% ropivacaine (max. dose 100 mg) perineurally.
|
|---|---|---|---|
|
Injury, poisoning and procedural complications
emergence delerium
|
4.0%
1/25 • From beginning of surgery until 2 weeks post-op, an average of 2 weeks.
|
0.00%
0/27 • From beginning of surgery until 2 weeks post-op, an average of 2 weeks.
|
0.00%
0/25 • From beginning of surgery until 2 weeks post-op, an average of 2 weeks.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place