Trial Outcomes & Findings for Ultrasound-guided Adductor Canal Block for Total Knee Replacement (NCT NCT02100579)
NCT ID: NCT02100579
Last Updated: 2017-07-11
Results Overview
Opioid consumption (morphine equivalents)
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
40 participants
Primary outcome timeframe
36 hours
Results posted on
2017-07-11
Participant Flow
Participant milestones
| Measure |
Active Group
Ultrasound-guided adductor canal blockade with 10 ml of 0.25% bupivacaine
Bupivacaine: 10 ml of 0.25% bupivacaine
|
Control Group
Ultrasound-guided sham block with 10 ml of preservative free normal saline
Preservative free normal saline: 10 ml of preservative free normal saline
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
20
|
|
Overall Study
COMPLETED
|
20
|
20
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Ultrasound-guided Adductor Canal Block for Total Knee Replacement
Baseline characteristics by cohort
| Measure |
Active Group
n=20 Participants
Ultrasound-guided adductor canal blockade with 10 ml of 0.25% bupivacaine
Bupivacaine: 10 ml of 0.25% bupivacaine
|
Control Group
n=20 Participants
Ultrasound-guided sham block with 10 ml of preservative free normal saline
Preservative free normal saline: 10 ml of preservative free normal saline
|
Total
n=40 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
|
8 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
12 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Age, Continuous
|
68 years
n=5 Participants
|
67 years
n=7 Participants
|
67 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 36 hoursOpioid consumption (morphine equivalents)
Outcome measures
| Measure |
Active Group
n=20 Participants
Ultrasound-guided adductor canal blockade with 10 ml of 0.25% bupivacaine
Bupivacaine: 10 ml of 0.25% bupivacaine
|
Control Group
n=20 Participants
Ultrasound-guided sham block with 10 ml of preservative free normal saline
Preservative free normal saline: 10 ml of preservative free normal saline
|
|---|---|---|
|
Opioid Consumption (mg morEq)
|
48 Morphine Equivalents
Interval 39.0 to 61.0
|
60 Morphine Equivalents
Interval 49.0 to 85.0
|
SECONDARY outcome
Timeframe: Pain burden at 36hrVisual Analog Scale pain score; 0 = no pain, 10 = excruciating pain) in the knee recorded every 6 hours up to 36hrs following surgery.
Outcome measures
| Measure |
Active Group
n=20 Participants
Ultrasound-guided adductor canal blockade with 10 ml of 0.25% bupivacaine
Bupivacaine: 10 ml of 0.25% bupivacaine
|
Control Group
n=20 Participants
Ultrasound-guided sham block with 10 ml of preservative free normal saline
Preservative free normal saline: 10 ml of preservative free normal saline
|
|---|---|---|
|
Visual Analog Scale Pain Score
|
71 scores*hours
Interval 37.0 to 120.0
|
131 scores*hours
Interval 92.0 to 161.0
|
SECONDARY outcome
Timeframe: 0 to 192 hoursThe average time to discharge in hours. Participants were discharged home went physical therapy criteria were met.
Outcome measures
| Measure |
Active Group
n=20 Participants
Ultrasound-guided adductor canal blockade with 10 ml of 0.25% bupivacaine
Bupivacaine: 10 ml of 0.25% bupivacaine
|
Control Group
n=20 Participants
Ultrasound-guided sham block with 10 ml of preservative free normal saline
Preservative free normal saline: 10 ml of preservative free normal saline
|
|---|---|---|
|
Length of Hospitalization
|
73 hours
Interval 64.0 to 83.0
|
92 hours
Interval 76.0 to 111.0
|
Adverse Events
Active Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control 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
Antoun Nader
Northwestern University, Feinberg School of Medicine
Phone: 312-695-3045
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place