Trial Outcomes & Findings for Adductor Canal Block Versus Periarticular Bupivicaine Injection in Total Knee Arthroplasty (NCT NCT02777749)
NCT ID: NCT02777749
Last Updated: 2019-03-20
Results Overview
Post-operatively, visual analog scale (VAS) pain scores will be recorded two times/day from Post-Operative Day (POD) 0 through POD3. VAS Scores range from 0 to 10, with 0 being "No Pain" and 10 being the "Worst Pain"
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
155 participants
Primary outcome timeframe
Day 0 through Day 3
Results posted on
2019-03-20
Participant Flow
Participant milestones
| Measure |
Adductor Canal Block
15 cc's of 0.5% bupivacaine preoperatively administered by the regional pain anesthesia team in the pre-operative block area, just prior to surgery.
Adductor Canal Block (ACB)
Bupivacaine: 15 cc's of 0.5% bupivacaine or 20 cc's short-acting bupivacaine (SB), intramuscular injection
|
Periarticular SB
50 cc's of bupivacaine will be injected intraoperatively, just prior to wound closure, by the performing surgeon.
Bupivacaine: 15 cc's of 0.5% bupivacaine or 50 cc's short-acting bupivacaine (SB), intramuscular injection
|
ACB + SB
15 cc's of 0.5% bupivacaine preoperatively administered by the regional pain anesthesia team in the pre-operative block area, just prior to surgery.
50 cc's of bupivacaine will be injected intraoperatively, just prior to wound closure, by the performing surgeon.
Bupivacaine: 15 cc's of 0.5% bupivacaine or 50 cc's short-acting bupivacaine (SB), intramuscular injection
|
|---|---|---|---|
|
Overall Study
STARTED
|
53
|
51
|
51
|
|
Overall Study
COMPLETED
|
53
|
51
|
51
|
|
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 |
Adductor Canal Block
n=53 Participants
15 cc's of 0.5% bupivacaine preoperatively administered by the regional pain anesthesia team in the pre-operative block area, just prior to surgery.
Adductor Canal Block (ACB)
Bupivacaine: 15 cc's of 0.5% bupivacaine or 20 cc's short-acting bupivacaine (SB), intramuscular injection
|
Periarticular SB
n=51 Participants
20 cc's of bupivacaine will be injected intraoperatively, just prior to wound closure, by the performing surgeon.
Bupivacaine: 15 cc's of 0.5% bupivacaine or 20 cc's short-acting bupivacaine (SB), intramuscular injection
|
ACB + SB
n=51 Participants
15 cc's of 0.5% bupivacaine preoperatively administered by the regional pain anesthesia team in the pre-operative block area, just prior to surgery.
20 cc's of bupivacaine will be injected intraoperatively, just prior to wound closure, by the performing surgeon.
Bupivacaine: 15 cc's of 0.5% bupivacaine or 20 cc's short-acting bupivacaine (SB), intramuscular injection
|
Total
n=155 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=53 Participants
|
0 Participants
n=51 Participants
|
0 Participants
n=51 Participants
|
0 Participants
n=155 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
14 Participants
n=53 Participants
|
9 Participants
n=51 Participants
|
13 Participants
n=51 Participants
|
36 Participants
n=155 Participants
|
|
Age, Categorical
>=65 years
|
39 Participants
n=53 Participants
|
42 Participants
n=51 Participants
|
38 Participants
n=51 Participants
|
119 Participants
n=155 Participants
|
|
Age, Continuous
|
69 years
STANDARD_DEVIATION 10 • n=53 Participants
|
73 years
STANDARD_DEVIATION 10 • n=51 Participants
|
71 years
STANDARD_DEVIATION 10 • n=51 Participants
|
71 years
STANDARD_DEVIATION 10 • n=155 Participants
|
|
Sex: Female, Male
Female
|
38 Participants
n=53 Participants
|
33 Participants
n=51 Participants
|
37 Participants
n=51 Participants
|
108 Participants
n=155 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=53 Participants
|
18 Participants
n=51 Participants
|
14 Participants
n=51 Participants
|
47 Participants
n=155 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
PRIMARY outcome
Timeframe: Day 0 through Day 3Post-operatively, visual analog scale (VAS) pain scores will be recorded two times/day from Post-Operative Day (POD) 0 through POD3. VAS Scores range from 0 to 10, with 0 being "No Pain" and 10 being the "Worst Pain"
Outcome measures
| Measure |
Adductor Canal Block
n=53 Participants
15 cc's of 0.5% bupivacaine preoperatively administered by the regional pain anesthesia team in the pre-operative block area, just prior to surgery.
Adductor Canal Block (ACB)
Bupivacaine: 15 cc's of 0.5% bupivacaine or 20 cc's short-acting bupivacaine (SB), intramuscular injection
|
Periarticular SB
n=51 Participants
50 cc's of bupivacaine will be injected intraoperatively, just prior to wound closure, by the performing surgeon.
Bupivacaine: 15 cc's of 0.5% bupivacaine or 50 cc's short-acting bupivacaine (SB), intramuscular injection
|
ACB + SB
n=51 Participants
15 cc's of 0.5% bupivacaine preoperatively administered by the regional pain anesthesia team in the pre-operative block area, just prior to surgery.
50 cc's of bupivacaine will be injected intraoperatively, just prior to wound closure, by the performing surgeon.
Bupivacaine: 15 cc's of 0.5% bupivacaine or 20 cc's short-acting bupivacaine (SB), intramuscular injection
|
|---|---|---|---|
|
Change in VAS Pain Scores
Day 0
|
3.0 scores on a scale
Standard Deviation 2.9
|
3.0 scores on a scale
Standard Deviation 3.0
|
2.7 scores on a scale
Standard Deviation 2.6
|
|
Change in VAS Pain Scores
Day 1
|
3.9 scores on a scale
Standard Deviation 2.3
|
3.8 scores on a scale
Standard Deviation 2.4
|
3.0 scores on a scale
Standard Deviation 2.1
|
|
Change in VAS Pain Scores
Day 2
|
4.1 scores on a scale
Standard Deviation 2.5
|
3.8 scores on a scale
Standard Deviation 2.4
|
3.3 scores on a scale
Standard Deviation 2.5
|
|
Change in VAS Pain Scores
Day 3
|
4.2 scores on a scale
Standard Deviation 3.1
|
3.0 scores on a scale
Standard Deviation 2.8
|
2.0 scores on a scale
Standard Deviation 2.0
|
SECONDARY outcome
Timeframe: Day 0 and Day 1Daily steps taken will be recorded. The more steps taken daily the better. Minimum is 0 steps, maximum is unlimited.
Outcome measures
| Measure |
Adductor Canal Block
n=53 Participants
15 cc's of 0.5% bupivacaine preoperatively administered by the regional pain anesthesia team in the pre-operative block area, just prior to surgery.
Adductor Canal Block (ACB)
Bupivacaine: 15 cc's of 0.5% bupivacaine or 20 cc's short-acting bupivacaine (SB), intramuscular injection
|
Periarticular SB
n=51 Participants
50 cc's of bupivacaine will be injected intraoperatively, just prior to wound closure, by the performing surgeon.
Bupivacaine: 15 cc's of 0.5% bupivacaine or 50 cc's short-acting bupivacaine (SB), intramuscular injection
|
ACB + SB
n=51 Participants
15 cc's of 0.5% bupivacaine preoperatively administered by the regional pain anesthesia team in the pre-operative block area, just prior to surgery.
50 cc's of bupivacaine will be injected intraoperatively, just prior to wound closure, by the performing surgeon.
Bupivacaine: 15 cc's of 0.5% bupivacaine or 20 cc's short-acting bupivacaine (SB), intramuscular injection
|
|---|---|---|---|
|
Change in Activity Level
Day 0
|
26 steps
Standard Deviation 33
|
68 steps
Standard Deviation 63
|
65 steps
Standard Deviation 50
|
|
Change in Activity Level
Day 1
|
124 steps
Standard Deviation 117
|
120 steps
Standard Deviation 117
|
139 steps
Standard Deviation 118
|
SECONDARY outcome
Timeframe: Day 0 through Day 3Total amount of opioid consumption post-operatively will be recorded. The less opioids consumed (mg) postoperatively the better. A morphine equivalence metric will be used for equianalgesic comparison. Minimum is 0 mg, maximum is unlimited.
Outcome measures
| Measure |
Adductor Canal Block
n=53 Participants
15 cc's of 0.5% bupivacaine preoperatively administered by the regional pain anesthesia team in the pre-operative block area, just prior to surgery.
Adductor Canal Block (ACB)
Bupivacaine: 15 cc's of 0.5% bupivacaine or 20 cc's short-acting bupivacaine (SB), intramuscular injection
|
Periarticular SB
n=51 Participants
50 cc's of bupivacaine will be injected intraoperatively, just prior to wound closure, by the performing surgeon.
Bupivacaine: 15 cc's of 0.5% bupivacaine or 50 cc's short-acting bupivacaine (SB), intramuscular injection
|
ACB + SB
n=51 Participants
15 cc's of 0.5% bupivacaine preoperatively administered by the regional pain anesthesia team in the pre-operative block area, just prior to surgery.
50 cc's of bupivacaine will be injected intraoperatively, just prior to wound closure, by the performing surgeon.
Bupivacaine: 15 cc's of 0.5% bupivacaine or 20 cc's short-acting bupivacaine (SB), intramuscular injection
|
|---|---|---|---|
|
Opioid Consumption
Combined (POD0 through POD3)
|
131 morphine equivalents
Standard Deviation 74
|
100 morphine equivalents
Standard Deviation 62
|
98 morphine equivalents
Standard Deviation 62
|
|
Opioid Consumption
POD0
|
33 morphine equivalents
Standard Deviation 15
|
31 morphine equivalents
Standard Deviation 18
|
35 morphine equivalents
Standard Deviation 21
|
|
Opioid Consumption
POD1
|
48 morphine equivalents
Standard Deviation 25
|
42 morphine equivalents
Standard Deviation 31
|
40 morphine equivalents
Standard Deviation 30
|
|
Opioid Consumption
POD2
|
35 morphine equivalents
Standard Deviation 29
|
20 morphine equivalents
Standard Deviation 22
|
18 morphine equivalents
Standard Deviation 21
|
|
Opioid Consumption
POD3
|
13 morphine equivalents
Standard Deviation 23
|
5.5 morphine equivalents
Standard Deviation 16
|
4.3 morphine equivalents
Standard Deviation 9
|
SECONDARY outcome
Timeframe: Postoperative day 21Range of knee flexion for active motion will be recorded at 3 week follow-up for all groups. The greater range of motion the better, with a good outcome considered at least 115 degrees of motion.
Outcome measures
| Measure |
Adductor Canal Block
n=53 Participants
15 cc's of 0.5% bupivacaine preoperatively administered by the regional pain anesthesia team in the pre-operative block area, just prior to surgery.
Adductor Canal Block (ACB)
Bupivacaine: 15 cc's of 0.5% bupivacaine or 20 cc's short-acting bupivacaine (SB), intramuscular injection
|
Periarticular SB
n=51 Participants
50 cc's of bupivacaine will be injected intraoperatively, just prior to wound closure, by the performing surgeon.
Bupivacaine: 15 cc's of 0.5% bupivacaine or 50 cc's short-acting bupivacaine (SB), intramuscular injection
|
ACB + SB
n=51 Participants
15 cc's of 0.5% bupivacaine preoperatively administered by the regional pain anesthesia team in the pre-operative block area, just prior to surgery.
50 cc's of bupivacaine will be injected intraoperatively, just prior to wound closure, by the performing surgeon.
Bupivacaine: 15 cc's of 0.5% bupivacaine or 20 cc's short-acting bupivacaine (SB), intramuscular injection
|
|---|---|---|---|
|
Range of Knee Flexion
|
99 degrees
Standard Deviation 15
|
104 degrees
Standard Deviation 12
|
101 degrees
Standard Deviation 16
|
SECONDARY outcome
Timeframe: Up to Day 5Total length of hospital stay from time of surgery through time of discharge will be recorded. The shorter the length of stay (days) the better. Range 0 days to 5 days.
Outcome measures
| Measure |
Adductor Canal Block
n=53 Participants
15 cc's of 0.5% bupivacaine preoperatively administered by the regional pain anesthesia team in the pre-operative block area, just prior to surgery.
Adductor Canal Block (ACB)
Bupivacaine: 15 cc's of 0.5% bupivacaine or 20 cc's short-acting bupivacaine (SB), intramuscular injection
|
Periarticular SB
n=51 Participants
50 cc's of bupivacaine will be injected intraoperatively, just prior to wound closure, by the performing surgeon.
Bupivacaine: 15 cc's of 0.5% bupivacaine or 50 cc's short-acting bupivacaine (SB), intramuscular injection
|
ACB + SB
n=51 Participants
15 cc's of 0.5% bupivacaine preoperatively administered by the regional pain anesthesia team in the pre-operative block area, just prior to surgery.
50 cc's of bupivacaine will be injected intraoperatively, just prior to wound closure, by the performing surgeon.
Bupivacaine: 15 cc's of 0.5% bupivacaine or 20 cc's short-acting bupivacaine (SB), intramuscular injection
|
|---|---|---|---|
|
Length of Hospital Stay
|
2.9 days
Standard Deviation 1.5
|
2.5 days
Standard Deviation 1.2
|
2.5 days
Standard Deviation 2.1
|
Adverse Events
Adductor Canal Block
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Periarticular SB
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
ACB + SB
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