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This article is featured in This Month in Anesthesiology, page 1A. Corresponding article on page 530.
Presented in part at the American Society of Regional Anesthesia Annual Meeting, San Diego, California, March 1518, 2012. Submitted for
publication January 10, 2013. Accepted for publication September 30, 2013. From the Department of Anesthesiology, Hospital for Special Surgery, New York, New York (D.H.K., Y.L., E.A.G., R.L.K., D.B.M., A.K.G., and J.T.Y.); Department of Anesthesiology and Critical Care Medicine,
The Johns Hopkins University, Baltimore, Maryland (A.M.); Department of Anesthesiology, Weill-Cornell Medical Center, New York, New
York (M.L.P.); and Department of Epidemiology and Biostatistics Core, Hospital for Special Surgery, New York, New York (Y.-y.L. and Y.M.).
Presented in part at the American Society of Regional Anesthesia Annual Meeting, San Diego, CA, March 1518, 2012.
Copyright 2014, the American Society of Anesthesiologists, Inc. Lippincott Williams & Wilkins. Anesthesiology 2014; 120:540-50
March 2014
PERIOPERATIVE MEDICINE
Physical therapists dangled patients (i.e., placed in sitting position with legs on the side of the bed) on POD 0
regardless of block status and patient readiness to ambulate. On POD 1 and afterward, patients were assessed and
encouraged to ambulate with assistance.
Noninferior analgesia was assessed by measuring both
NRS pain scores and opioid consumption, data collected
included: (1) NRS pain scores (determined by patient interview, using the standard NRS of 0 to 10, at 6 to 8, 24, and
48h); and (2) total morphine consumption (converting oral,
intravenous, and epidural opioid to morphine equivalent on
PODs 0, 1, and 2). To strengthen the claim that the ACB
was noninferior in analgesia to the FNB, we decided to conduct a joint hypothesis test using both pain score and opioid
consumption as primary outcomes.
Additional data collected included: (1) patient satisfaction (patient interviewed, using a scale of 010, 10 being the
most satisfied, at 68 and 24h); (2) postoperative nausea and
vomiting (present or absent, determined by patient interview
at 68, 24, and 48h); (3) pruritis, (present or absent, determined by patient interview at 68, 24, and 48h); (4) incidence of complications (if any), including falls, neurologic
symptoms, and local anesthetic toxicity; (5) length of hospital
stay (days); (6) success of blinding (by asking patients before
discharge which treatment they thought they had received.
Statistical Analysis
Standardized difference was calculated to compare patient
demographics and baseline characteristics including age,
sex, race, American Society of Anesthesiologists, length of
hospital stay, and body mass index between ACB and FNB.
An absolute difference greater than 0.2 was considered to be
clinically important.16,17 To reduce the chance of confounding, the clinically important variables were adjusted in multiple regression analysis.
The primary outcomes included quadriceps muscle
strength as measured by dynamometer reading, NRS pain
scores, and total opioid consumption. We hypothesized that
ACB would be preferred if (1) ACB was noninferior to FNB
on all primary outcomes and (2) ACB was superior to FNB at
least on quadriceps muscle strength. Therefore we conducted
a joint hypothesis testing as described by Mascha and Turan.18
A two-step sequential testing procedure18 was followed
for the joint hypothesis testing of (1) and (2), both at 6 to
8h postanesthesia administration. First, noninferiority was
assessed on each individual outcome. Specifically, the following noninferiority was defined for ACB as compared with
FNB: (1) the mean dynamometer readings not less than 3 kgf
(equivalent to a clinically relevant difference of 20% points as
described in Ilfeld etal.19) lower than FNB (2) the mean NRS
pain score not more than 1.6 higher than FNB,20 and (3) the
mean opioid consumption not more than 50% greater than
FNB.2 Second, we evaluated the superiority on each outcome
if noninferiority was confirmed on all outcomes. Noninferiority hypotheses were evaluated against a one-sided significance
PERIOPERATIVE MEDICINE
were originally randomly assigned, regardless of the treatment they actually received. SAS version 9.3 (SAS Institute,
Cary, NC) was used for all analyses.
Results
Patients were enrolled from March 2011 to November
2011. Patient recruitment and flow through the protocol are
described in the CONSORT (Consolidated Standards Of
Reporting Trials) diagram. Of the 94 patients enrolled, one
patient was excluded for inappropriate enrollment (fig.1).
The patient had a profound preexisting neurological condition (significant quadriceps weakness and numbness at baseline) and should not have been enrolled. Four patients were
noted to have failed blocks (i.e., no loss of sensation in the
saphenous distribution). Success rates for the ACB and FNB
were 93.6 and 97.9%, respectively. Three patients did not
have an epidural PCA postoperatively (1 intrathecal catheter, 2 spinals only) but an intravenous PCA. Four patients
withdrew from the study on POD 0 or 1, but all available
data were included in the intention-to-treat analysis. Three
patients were not assessed by the research assistant at either
the postanesthesia care unit, PODs 1 and/or 2 time points,
but all other available data were included in the intentionto-treat analysis. After the exclusion, 46 patients received
ACB; 47 patients received FNB. Baseline values were similar
between the two groups (table1), with the exception of the
Excluded (n = 137)
Did not meet inclusion criteria (n = 82)
Declined to participate (n = 55)
Randomized (n = 94)
Analyzed (n = 47)
Analyzed (n = 46)
Fig. 1. CONSORT (Consolidated Standards Of Reporting Trials) diagram. Flow of patients through the protocol.
Table 1. Demographics
Status, N (%)
Included in per-protocol
analysis
Excluded
Age, mean SD
Age, N (%)
Age group 1: age 50
Age group 2: 50 < age 60
Age group 3: 60 < age 70
Age group 4: 70 < age 80
Age group 5: 80 < age
Sex, N (%)
Male
Female
Race, N (%)
Asian
Black
Hispanic
White
Other/unknown
ASA, N (%)
1
2
3
Hospital stay, mean SD
BMI, mean SD
BMI, N (%)
Normal: 18.5 < BMI < 25
Overweight: 25 BMI < 30
Obese class I: 30 BMI < 35
Obese class II: 35 BMI < 40
Obese class III: 40 BMI
ACB
FNB
N = 46
N = 47
Standardized Difference
40 (87.0)
39 (83.0)
0.111
6 (13.0)
68.09.4
8 (17.0)
67.611.3
3 (6.5)
6 (13.0)
20 (43.5)
13 (28.3)
4 (8.7)
4 (8.5)
8 (17.0)
14 (29.8)
16 (34.0)
5 (10.6)
22 (47.8)
24 (52.2)
18 (38.3)
29 (61.7)
0
3 (6.5)
2 (4.3)
40 (87.0)
1 (2.2)
1 (2.1)
5 (10.6)
1 (2.1)
39 (83.0)
1 (2.1)
2 (4.3)
38 (82.6)
6 (13.0)
3.70.8
29.96.4
3 (6.4)
36 (76.6)
8 (17.0)
3.60.8
30.35.8
13 (28.3)
17 (37.0)
5 (10.9)
6 (13.0)
5 (10.9)
10 (21.3)
16 (34.0)
9 (19.1)
9 (19.1)
3 (6.4)
0.043
0.075
0.111
0.287
0.125
0.066
0.193
0.209
0.147
0.126
0.111
0.003
0.09
0.15
0.111
0.07
0.072
0.162
0.061
0.233
0.167
0.16
ACB
FNB
Difference
N = 46
N = 47
ACB-FNB
(95% CI)*
7.35.4
6.1 [3.5, 10.9]
1.71.9
1.0 [0.0, 3.5]
36.617.9
32.2 [22.4, 47.5]
2.23.8
0.0 [0.0, 3.9]
0.91.8
0.0 [0.0, 1.0]
35.820.7
26.6 [19.6, 49.0]
P Value
(HolmBonferroni)
Delta
P Value
<0.0001
1.6
0.019
0.9999
1.5
0.0115
0.9999
<0.0001
Results presented as mean SD, median [first, third quartiles]. Overall alpha is 0.025 for both noninferiority and superiority tests. Noninferiority was found
on all three outcomes with the given deltas (P < 0.025) and superiority on dynamometer readings (P < 0.008).
* Noninferiority test is significant for dynamometer readings (NRS, opioids) if the lower (upper) confidence limit is greater (less) than delta. Superiority test
is significant for dynamometer readings (NRS) if lower (upper) confidence limit is greater (less) than zero; superiority test is significant for opioids use if the
upper confidence limit is <1. Ratio of ACB/FNB.
ACB = adductor canal block; FNB = femoral nerve block; NRS = Numeric Rating Scale; PCA = patient-controlled analgesia.
PERIOPERATIVE MEDICINE
that ACB was not inferior to FNB with regard to the NRS
pain scores at rest throughout the first 48h.
The ACB group had a cumulative opioid intake that
was not inferior to the FNB group at 6 to 8h postanesthesia (table5, ratio: ACB/FNB [95% CI], 1.05 [0.81.3];
P = 0.0029). Similarly, ACB was not inferior to FNB with regard
to opioid use throughout the first 48h (noninferiority P value of
0.0115, and 0.0029 at 24 and 48h, respectively). The upper CI
limits at all times were less than the delta of 1.5. All patients analyzed had a bupivacaine/hydromorphone epidural PCA or an
intravenous hydromorphone PCA (n = 3), which was discontinued on POD 2. Even after the patient-controlled epidural analgesia was discontinued on POD 2, there was no difference in
oral consumption between the two groups by discharge (fig.2).
Time of Follow-up
Operative leg
Preoperative, kgf
Postanesthesia 68 h, kgf
Postanesthesia 24 h, kgf
Postanesthesia 48 h, kgf
Nonoperative leg
Preoperative, kgf
Postanesthesia 68 h, kgf
Postanesthesia 24 h, kgf
Postanesthesia 48 h, kgf
ACB
FNB
N = 46
N = 47
15.68.5
12.3 [9.6, 20.2]
7.35.4
6.1 [3.5, 10.9]
3.94.2
3.5 [1.1, 4.4]
2.22.9
1.8 [0.0, 3.3]
14.88.2
11.6 [8.3, 20.1]
2.23.8
0.0 [0.0, 3.9]
4.04.0
2.8 [1.1, 6.8]
2.83.2
1.7 [0.0, 4.1]
18.59.1
16.7 [11.6, 24.4]
15.87.6
14.4 [9.9, 21.3]
16.77.4
15.7 [10.2, 22.6]
16.77.8
15.1 [12.0, 22.0]
18.39.2
16.9 [10.7, 27.4]
16.210.3
13.9 [8.1, 25.4]
17.89.0
16.9 [10.1, 25.4]
18.511.8
16.4 [9.2, 26.3]
Difference:
ACB-FNB (95% CI)
Test of Equal
Medians:
P Value
(HolmBonferroni)*
0.9999
<0.0001
0.9999
0.9999
0.9999
0.9999
0.9999
0.9999
Time of Follow-up
Preoperative
Postanesthesia 68 h
Postanesthesia 24 h
Postanesthesia 48 h
ACB
FNB
N = 46
N = 47
3.03.2
2.0 [0.0, 6.0]
1.71.9
1.0 [0.0, 3.5]
3.12.3
3.0 [1.5, 5.0]
4.32.2
4.0 [3.0, 6.0]
3.43.1
3.0 [0.0, 5.0]
0.91.8
0.0 [0.0, 1.0]
2.82.3
3.0 [1.0, 4.0]
4.83.0
4.8 [3.0, 7.3]
Difference:
ACB-FNB (95% CI)
Noninferiority
One-tailed
Test*: P Value
(HolmBonferroni)
0.0075
0.0190
0.0103
0.0005
Results presented as mean SD, median [first, third quartiles]. HolmBonferroni adjusted P < 0.025 is considered statistically significant.
* Delta = 1.6 for the noninferiority test.
ACB = adductor canal block; FNB = femoral nerve block; NRS = Numeric Rating Scale.
Fig. 2. Total opioid use over time. The plus sign represents the femoral nerve block group and the triangle represents the adductor canal block group.
FNB
N = 46
N = 47
36.617.9
32.2 [22.4, 47.5]
50.330.8
46.8 [30.0, 60.6]
60.732.3
62.4 [41.0, 76.2]
35.820.7
26.6 [19.6, 49.0]
50.433.1
40.2 [29.7, 70.5]
62.839.1
57.8 [35.0, 77.4]
Ratio: ACB/FNB
(95% CI)
Noninferiority
One-tailed Test*: P Value
(HolmBonferroni)
1.05 (0.81.3)
0.0029
1.03 (0.71.4)
0.0115
0.95 (0.71.3)
0.0029
Results presented as mean SD, median [first, third quartiles]. HolmBonferroni adjusted P < 0.025 is considered statistically significant.
* Delta = 1.5 for the noninferiority test.
ACB = adductor canal block; FNB = femoral nerve block; PCA = patient-controlled analgesia.
PERIOPERATIVE MEDICINE
Discussion
This prospective study demonstrated that the ACB is an effective alternative to the FNB for patients undergoing TKA.
The ACB exhibited significant sparing of the quadriceps
strength at 6 to 8h and was not inferior to the FNB regarding pain scores and opioid consumption.
Several studies validated the ACB as an effective analgesic
method, but most studied arthroscopic knee surgery.2 This
study compared ACB with FNB in patients undergoing
TKA, a more painful procedure that requires optimal pain
relief to hasten mobilization. Jenstrup etal.25 demonstrated
effectiveness of the ACB on pain and ambulation after TKA,
compared with placebo. Strength was not objectively measured and the study involved a high dose of local anesthetic
(30ml of 0.75% ropivacaine, 225mg). This large dose of
local anesthetic could cause quadriceps weakness from proximal spread. The current study used a lower dose of anesthetic
(75mg bupivacaine) and directly compared ACB with FNB.
At 6 to 8h postanesthesia, median strength for ACB
patients was reduced compared with baseline. One explanation could be blockade of the nerve going to the vastus
Table 6. The Estimated Covariate-adjusted Treatment Effects and Differences between Treatments from the Regression Analysis
Based on GEE
Covariates
Dynamometer readings
Difference in dynamometer readings between ACB and FNB at each time point:
Preoperative
0.33 (3.14 to 3.79)
Postanesthesia 68 h
4.91 (1.798.03)
Postanesthesia 24 h
0.24 (2.46 to 1.98)
Postanesthesia 48 h
0.17 (2.67 to 2.34)
Nonoperative leg
0.35 (0.290.42)
2.18 (0.543.82)
50 < age 60 vs. age 50
3.13 (1.215.05)
60 < age 70 vs. age 50
3.18 (1.494.86)
70 < age 80 vs. age 50
1.77 (0.40 to 3.93)
80 < age vs. age 50
Male vs. female
1.05 (0.121.98)
Asian vs. White
0.60 (1.78 to 0.58)
Black vs. White
0.50 (1.61 to 0.61)
Hispanic vs. White
4.36 (0.997.72)
Others vs. White
1.95 (3.51 to 0.39)
Overall NRS pain scores at rest
Postanesthesia 68 h vs. preoperative
1.89 (2.66 to 1.12)
Postanesthesia 24 h vs. preoperative
0.23 (0.96 to 0.51)
Postanesthesia 48 h vs. preoperative
1.36 (0.602.12)
ACB vs. FNB
0.08 (0.56 to 0.71)
0.27 (1.75 to 1.21)
50 < age 60 vs. age 50
1.07 (2.45 to 0.30)
60 < age 70 vs. age 50
0.58 (1.99 to 0.84)
70 < age 80 vs. age 50
0.27 (2.31 to 1.77)
80 < age vs. age 50
Overall opioids (oral opioids + PCA)
Postanesthesia 24 h vs. preoperative
14.11 (8.5519.68)
Postanesthesia 48 h vs. preoperative
25.56 (19.0232.09)
ACB vs. FNB
0.35 (9.69 to 8.99)
20.72 (52.75 to 11.30)
50 < age 60 vs. age 50
25.46 (54.85 to 3.93)
60 < age 70 vs. age 50
29.68 (59.12 to 0.24)
70 < age 80 vs. age 50
33.31 (63.94 to 2.68)
80 < age vs. age 50
P Value
0.7689
<0.0001
0.7356
0.8345
<0.0001
0.0093
0.0014
0.0002
0.1099
0.0264
0.3160
0.3748
0.0112
0.0145
<0.0001
0.5500
0.0005
0.8144
0.7208
0.1267
0.4238
0.7964
<0.0001
<0.0001
0.9415
0.2047
0.0896
0.0482
0.0331
FNB
N = 47
N (%)
2 (4.5)
15 (35.7)
13 (29.6)
6 (14.3)
22 (52.4)
19 (43.2)
9.80.6
10.0 [10.0, 10.0]
8.81.9
10.0 [8.0, 10.0]
3.70.8
3.5 [3.0, 4.0]
5 (11.1)
16 (35.6)
11 (23.9)
7 (15.6)
19 (42.2)
15 (33.3)
9.60.9
10.0 [10.0, 10.0]
9.11.7
10.0 [8.5, 10.0]
3.60.8
4 [3.0, 4.0]
Time of Follow-up
Nausea or vomiting
Pruritis
Patient satisfaction
Postanesthesia 628 h
Postanesthesia 24 h
Postanesthesia 48 h
Postanesthesia 68 h
Postanesthesia 24 h
Postanesthesia 48 h
Postanesthesia 68 h
Postanesthesia 24 h
Hospital stay
P Value
(HolmBonferroni)
0.9999
0.9999
0.9999
0.9999
0.9999
0.9999
0.6439
0.5041
0.7346
Results presented as frequency (percentage) for discrete outcomes and mean SD, median [first, third quartiles] for continuous outcomes. HolmBonferroni adjusted P < 0.05 is considered statistically significant.
ACB = adductor canal block; FNB = femoral nerve block.
ACB
FNB
Guessed
ACB
Guessed
FNB
Do Not
Know
N (%)
N (%)
N (%)
Total
Assessed
9 (24)
10 (27)
6 (16)
10 (27)
22 (60)
17 (46)
37
37
with assistance. Future studies could investigate the relationship between improved early quadriceps strength and time
of achievement of physical therapy milestones.
No falls were noted in this study. However, three patients
in the FNB group were noted to buckle due to quadriceps
weakness on POD 1. No patients in the ACB group were
noted to be weak on POD 1. However, given the small sample
size of this study (n = 94), it would be difficult to assess fall risk
reduction. Other secondary outcomes like nausea and vomiting, pruritus, patient satisfaction, length of stay, and complications showed no significant difference. This can be attributed
to the ACB providing analgesia that is no different than that of
FNB, thus limiting the known side effects of opioid use (e.g.,
nausea, pruritus). Patients were blinded successfully, which
further strengthens the argument that the ACB provided
adequate analgesia to blind the patients regarding which block
was performed. However, the successful pain relief can also be
attributed in part to the postoperative use of an epidural PCA
and further studies could limit the use of an epidural (i.e., no
continuous infusion) or use an intravenous PCA.
Though we powered the study using a 50% difference
in motor strength between the two groups, we performed a
power analysis for NRS pain score and opioid consumption
at 6 to 8h. A difference of 1.6 and an increase of 50% (ACB
vs. FNB) were considered clinically significant for NRS pain
score and opioid consumption, respectively. With the given
sample size (n = 46 for ACB and n = 47 for FNB), we were
able to detect clinical significance with a power of 98.4 and
97.9% for pain score and opioid consumption, respectively.
The sample size, however, was underpowered to detect significant difference in the complications, for example, falls,
neuropraxia, and nausea and vomiting.
A major concern among practitioners is whether an ACB
provides enough sensory coverage for a TKA. It is important
to note that the ACB performed at the level of the midthigh involves not only the saphenous nerve but several
PERIOPERATIVE MEDICINE
Acknowledgments
The authors thank Dorothy Marcello, B.A., Department of
Anesthesiology, Hospital for Special Surgery, New York,
New York, for assistance with patient enrollment and data
entry.
Study funded by the Hospital for Special Surgery Anesthesiology Department (New York, New York)Research
and Education Fund. The Agency for Healthcare Research
and Quality (Rockville, Maryland) grant R01HS021734 supported Dr. Mas research.
Competing Interests
The authors declare no competing interests.
Correspondence
Address correspondence to Dr. Kim: Department of Anesthesiology, Hospital for Special Surgery, 535 East 70th Street,
New York, New York 10021. kimd@hss.edu. This article may
be accessed for personal use at no charge through the Journal Web site, www.anesthesiology.org.
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On Ether Days Eve, October 15, 1958, Dr. Paul M. Wood received Active Membership Certificate No. 21 (above)
from The Academy of Anesthesiology. Founded by Mayo Clinics John S. Lundy, M.D., in 1929, as the Anaesthetists
Travel Club, this organization of leading North American anesthesiologists met annually to update each other on
advances in the art and science of anesthesiology. The Travel Club was resurrected, after a brief wartime lapse, as
The Academy of Anesthesiology in 1952. The Academy continues today with active membership limited to 75
anesthesiologists. (Copyright the American Society of Anesthesiologists, Inc.)
George S. Bause, M.D., M.P.H., Honorary Curator, ASAs Wood Library-Museum of Anesthesiology, Park Ridge,
Illinois, and Clinical Associate Professor, Case Western Reserve University, Cleveland, Ohio. UJYC@aol.com.