Original article
Regional Anesthesia & Pain Medicine: first published as 10.1136/rapm-2018-000032 on 3 January 2019. Downloaded from file:/ on 5 February 2019 by guest. Protected by copyright.
1
Department of Anesthesia,
Hospital Clínico Universidad
de Chile, University of Chile,
Santiago, Chile
2
Department of Anesthesia,
Maharaj Nakorn Chiang Mai
Hospital, Chiang Mai University,
Chiang Mai, Thailand
3 in equivalent durations of motor block (equivalence
Department of Anesthesia,
Montreal General Hospital,
McGill University, Montreal,
Quebec, Canada
4 upper limb surgery with ultrasound-guided infraclavicular
Department of Anesthesia,
Ramathibodi Hospital, Mahidol
University, Bangkok, Thailand
Correspondence to
De Q Tran, Department of
Anesthesia, Montreal General
Hospital, Montreal, QC H3G-
1A4, Canada;
​de_​tran@​hotmail.​com
Received 24 June 2018
Revised 11 July 2018
Accepted 23 July 2018
© American Society of Regional
Anesthesia & Pain Medicine
2019. No commercial re-use.
See rights and permissions.
Published by BMJ.
To cite: Bravo D,
Aliste J, Layera S, et al.
Reg Anesth Pain Med
2019;44:46–51.
46    Bravo D, et al. Reg Anesth Pain Med 2019;44:46–51. doi:10.1136/rapm-2018-000032
A multicenter, randomized comparison between 2, 5,
and 8 mg of perineural dexamethasone for
ultrasound-guided infraclavicular block
Daniela Bravo,1 Julian Aliste,1 Sebastián Layera,1 Diego Fernández,1
Prangmalee Leurcharusmee,2 Artid Samerchua,2 Amornrat Tangjitbampenbun,3
Arraya Watanitanon,3 Vanlapa Arnuntasupakul,4 Choosak Tunprasit,4 Aida Gordon,3
Roderick J Finlayson,3 De Q Tran3
Abstract
Background and objectives  This multicenter,
randomized trial compared 2, 5, and 8 mg of perineural
dexamethasone for ultrasound-guided infraclavicular
brachial plexus block. Our research hypothesis was
that all three doses of dexamethasone would result
margin=3.0 hours).
Methods  Three hundred and sixty patients undergoing
block were randomly allocated to receive 2, 5, or 8 mg
of preservative-free perineural dexamethasone. The local
anesthetic agent (35 mL of lidocaine 1%-bupivacaine
0.25% with epinephrine 5 µg/mL) was identical in all
subjects. Patients and operators were blinded to the
dose of dexamethasone. During the performance of
the block, the performance time, number of needle
passes, procedural pain, and complications (vascular
puncture, paresthesia) were recorded. Subsequently
a blinded observer assessed the success rate (defined
as a minimal sensorimotor composite score of 14
out of 16 points at 30 min), onset time as well as the
incidence of surgical anesthesia (defined as the ability to
complete surgery without local infiltration, supplemental
blocks, intravenous opioids, or general anesthesia).
Postoperatively, the blinded observer contacted patients
with successful blocks to inquire about the duration of
motor block, sensory block, and postoperative analgesia.
The main outcome variable was the duration of motor
block.
Results  No intergroup differences were observed in
terms of technical execution (performance time/number
of needle passes/procedural pain complications),
onset time, success rate, and surgical anesthesia.
Furthermore, all three doses of dexamethasone
provided similar durations of motor block (14.9–16.1
hours) and sensory block. Although 5 mg provided a
longer analgesic duration than 2 mg, the difference
(2.7 hours) fell within our pre-established equivalence
margin (3.0 hours).
Conclusions  2, 5, and 8 mg of dexamethasone provide
clinically equivalent sensorimotor and analgesic durations
for ultrasound-guided infraclavicular block. Further trials
are required to compare low (ie, 2 mg) and ultra-low
(eg, 0.5–1 mg) doses of perineural dexamethasone for
brachial plexus blocks.
Trial registration number TCTR20150624001.
Introduction
Intravenous and perineural (PN) dexamethasone
have been previously shown to prolong the dura-
tion of brachial plexus blocks.1–17 Postulated mech-
anisms of action include inhibition of nociceptive
C fibers, suppression of ectopic neural discharge,
peripheral/central anti-inflammatory effects, and
suppression of the neuropeptide immune response
to injury.15 In two recent trials (combined n=300),
our research team has demonstrated that PN dexa-
methasone outperforms its intravenous counter-
part for infraclavicular and axillary brachial plexus
blocks.18 19 At present time, the optimal dose of
PN dexamethasone remains controversial. While
some authors advocate “low” doses (ie, 2 mg),20
others have employed “intermediate” doses (ie, 4–5
mg).2 4 6 12 18 In contrast, the majority of published
studies have favored a “high” dose (ie, 8–10 mg) of
PN dexamethasone.1–3 7–11 13–17 19 21
In this multicenter, randomized trial, we set out
to compare low (2 mg), intermediate (5 mg), and
high (8 mg) doses of PN dexamethasone for ultra-
sound (US)-guided infraclavicular brachial plexus
block (ICB). Because the most recent evidence
pertaining to intravenous dexamethasone suggests
minimal differences between 4 and 10 mg,22 we
hypothesized that all three PN doses would also
result in similar block durations, and consequently
designed the study as an equivalence trial. Since
analgesic and sensory duration can be influenced
by postoperative analgesic regimen and surgical
trauma to small cutaneous nerves, respectively, we
selected the duration of motor block as the primary
outcome.18 19
Materials and methods
The current trial was registered at www.​ clin-
icaltrials.​
in.​
th (trial registration number:
TCTR20170720001) on July 20, 2017. After
obtaining ethics committee approval and written
informed consent, we enrolled 360 patients under-
going surgery of the forearm, wrist, or hand.
Inclusion criteria were age between 18 and 80
years, American Society of Anesthesiologists phys-
ical status I–III, and body mass index between 18
and 35 kg/m2. Exclusion criteria were inability to
consent to the study, coagulopathy, sepsis, hepatic
or renal failure, allergy to local anesthetic (LA),

Figure 1  CONSORT diagram of patient flow through the study. Onset times could not be recorded for patients with minimal composite scores <14
points at 30 min. However the performance time, number of needle passes, procedural pain, operator’s experience level, adverse events (vascular
puncture/paresthesia), and surgical anesthesia were recorded for these subjects. CONSORT, Consolidated Standards of Reporting Trials; OR, operating
room.
pre-existing muculocutaneous/median/radial/ulnar neuropathy,
and prior surgery in the infraclavicular fossa.
After arrival in the induction room, an 18-gauge or 20-gauge
intravenous catheter was placed in the upper limb contralateral
to the surgical site, and intravenous premedication (0.015–0.03
mg/kg of midazolam and 0.6 µg/kg of fentanyl) was administered
to patients if necessary. Supplemental oxygen (nasal cannulae
at 4 L/min) and pulse oximetry were applied throughout the
procedure.
The ICB was performed according to a previously described
technique (add references 18, 23). A 6–13 MHz linear US trans-
ducer (SonoSite M-Turbo, SonoSite, Bothell, Washington, USA;
or General Electric LOGIC E, General Electric Healthcare,
Wauwatosa, Wisconsin, USA) was applied in a sterile fashion
in the infraclavicular fossa, medially to the coracoid process,
to obtain a short axis view of the axillary artery. A skin weal
was raised with 3 mL of 1.0% lidocaine. Using an inplane
technique and a cephalad to caudad direction, a 21-gauge or
22-gauge, 90–100 mm block needle (StimuQuik Echo, Arrow
International, Reading, Pennsylvania, USA; UniPlex NanoLine,
Pajunk, Geisingen, Germany; Stimuplex Ultra 360, B Braun
Medical AG, Melsungen, Germany; or Stimuplex A, B Braun
Medical AG) was advanced until its tip was located dorsal to the
axillary artery. Thirty-five milliliters of lidocaine 1.0%-bupiva-
caine 0.25% (obtained by mixing equal parts of lidocaine 2%
and bupivacaine 0.5%) with epinephrine 5 µg/mL were incre-
mentally injected. Using a computer-generated sequence of
random numbers and a sealed envelope technique, patients were
randomly allocated to receive 2, 5, or 8 mg of preservative-free
PN dexamethasone. Subjects were randomized in blocks of 15
Bravo D, et al. Reg Anesth Pain Med 2019;44:46–51. doi:10.1136/rapm-2018-000032
Original article
Regional Anesthesia & Pain Medicine: first published as 10.1136/rapm-2018-000032 on 3 January 2019. Downloaded from file:/ on 5 February 2019 by guest. Protected by copyright.
to ensure equal distribution of the three study groups. Based
on anticipated surgical volume, the Santiago, Montreal, Chiang
Mai, and Bangkok centers were assigned 10, 5, 5, and 4 blocks
of 15 patients, respectively. Randomization was independently
carried out in each of the four centers. The study solutions were
prepared by an investigator not involved in clinical care; thus,
patients, operators, and outcome assessors remained blinded to
the dose of PN dexamethasone.
All blocks were performed by residents, fellows, or staff
anesthesiologists. Independently of their status, operators were
considered experts for a given approach if, prior to the start of
the study, they possessed an experience level equal or superior
to 60 ICBs. Otherwise they were considered trainees.24 For
both groups, the imaging time was defined as the time interval
between contact of the US probe with the patient and the acqui-
sition of a satisfactory picture. The needling time (defined as the
temporal interval between the start of the skin weal and the end
of LA injection through the block needle) was also recorded.
Thus, performance time was defined as the sum of imaging and
needling times. The number of needle passes was also recorded.
The initial needle insertion counted as the first pass. Any subse-
quent needle advancement that was preceded by a retraction of
at least 10 mm counted as an additional pass.25 Furthermore,
the level of procedural pain (0=no pain; 10=worst imaginable
pain) as well as the incidence of vascular puncture and pares-
thesia were recorded.
After LA injection through the block needle, measurements of
brachial plexus blockade were carried out every 5 min until 30
min by a blinded observer. Sensory blockade of the musculocu-
taneous, median, radial, and ulnar nerves was graded according
47
 Original article

Regional Anesthesia & Pain Medicine: first published as 10.1136/rapm-2018-000032 on 3 January 2019. Downloaded from file:/ on 5 February 2019 by guest. Protected by copyright.
or LA infiltration by the surgeon (add references 18 and 23).
Table 1  Patient characteristics
However, in case of anxiety (as voiced by patients or deter-
2 mg 5 mg 8 mg mined by the treating anesthesiologists), subjects could receive a
(n=119) (n=120) (n=120) P values
propofol infusion (25–80 µg/kg/min) intraoperatively, provided
Age (years) 44.5±15.7 46.6±16.6 46.7±15.9 0.480 response to verbal stimulus was maintained. The blinded
Sex (male/female) 58/61 69/51 56/64 0.205 observer also recorded the patient’s anthropometric data.
BMI (kg/m²) 25.0±4.0 25.7±4.1 26.5±4.9 0.036* Postoperatively, patients with successful blocks (minimal
ASA physical status (I/II/III) 65/50/4 66/52/2 60/56/4 0.522 composite score of 14 points at 30 min) were provided a data-
Types of surgery 48/46/17/8 65/33/17/5 56/36/21/7 0.394 sheet to record the exact time when they first regained sensa-
(hand/wrist/forearm/elbow) tion in the fingers (duration of sensory block), moved the fingers
Continuous variables are presented as mean±SD; categorical variables are (duration of motor block), and experienced pain at the surgical
presented as counts. site (analgesic duration). We did not seek sensation or movement
*Statistically significant difference: 8 mg vs 2 mg and 5 mg. of specific digits but only of those whose tips were not covered
ASA, American Society of Anesthesiologists; BMI, body mass index. by the cast. The blinded observer contacted study subjects at 24
hours for data collection. In the event that patients could not
to a 3-point scale using a cold test: 0=no block, 1=analgesia be reached or that ICBs had receded during sleep, we did not
(patient can feel touch, not cold), and 2=anesthesia (patient record any data for the duration of sensorimotor block and post-
cannot feel touch).18 19 Sensory blockade of the musculocuta- operative analgesia. However data pertaining to technical execu-
neous, median, radial, and ulnar nerves was assessed on the tion/onset/success/surgical anesthesia were retained for analysis
lateral aspect of the forearm, the volar aspect of the thumb, the (figure 1).
lateral aspect of the dorsum of the hand, and the volar aspect of One week after the surgery, patients were contacted by the
the fifth finger, respectively.18 19 Motor blockade was also graded blinded investigator to inquire about complications such as
on a 3-point scale: 0=no block, 1=paresis, and 2=paralysis.18 19 persistent numbness/paresthesia or motor deficit.
Motor blockade of the musculocutaneous, radial, median, and
ulnar nerves was evaluated by elbow flexion, thumb abduction, Statistical analysis
thumb opposition, and thumb adduction, respectively. 18 19 Our previous experience with PN dexamethasone (5 mg) for
Overall the maximal composite score was 16 points. We consid- US-guided ICB revealed a motor block duration of 15.7±6.2
ered the block a success and the patient ready for surgery when hours.18 For the current study, we speculated equivalency
a minimal composite score of 14 points was achieved, provided between 2, 5, and 8 mg of PN dexamethasone and thus designed
the sensory block score was equal or superior to 7 out of 8 the protocol as an equivalence trial. We deemed that a 20%
points. This scale has been used in previous studies. 18 19 The difference in motor block duration (3 hours) carries minimal
onset time was defined as the time required to obtain 14 points. clinical significance, and therefore set our equivalence margin at
If after 30 min the composite score was inferior to 14 points, ±3 hours. A calculated sample size of 270 patients was required
the patient was transferred to the operating room for the start of to provide a statistical power of 0.90 and a type I error of 0.025
the surgery. For these patients, we did not record an onset time. (one-way analysis of variance [ANOVA]). Since block duration
Surgical anesthesia was recorded by the same blinded observer can only be calculated for successful blocks and since we antic-
and defined as the ability to proceed with surgery without the ipated a 90% success rate with a 35 mL volume,23 300 subjects
need for intravenous narcotics, general anesthesia, rescue blocks, needed to be enrolled to account for block failure. Furthermore,

Table 2  Block performance data and durations of sensorimotor block and postoperative analgesia
2 mg 5 mg 8 mg P values
Imaging time (s) 28.7±28.6 30.1±30.2 30.4±27.2 0.890
Needling time (min) 5.7±2.3 5.8±2.3 6.2±2.5 0.272
Performance time (min) 6.2±2.3 6.3±2.4 6.7±2.6 0.258
Onset time (min) 18.6±6.5 18.2±6.2 18.9±6.2 0.711
Total anesthesia-related time (min) 24.6±7.3 24.4±6.8 25.5±6.7 0.483
Blocks with a minimal composite score of 14 points 115 (96.6) 111 (92.5) 117 (97.5) 0.134
Surgical anesthesia 118 (99.2) 115 (95.8) 117 (97.5) 0.540
Operator’s experience level (expert/trainee) 23/96 27/93 24/96 0.919
Number of passes 2 (1–5) 2 (1–4) 2 (1–6) 0.994
Block-related pain (scale 0–10) 1 (0–6) 1 (0–8) 1 (0–7) 0.841
Duration of motor block (hours) 14.9±4.5 16.1±4.9 15.3±4.5 0.148
(95% CI) (14.1 to 15.8) (15.1 to 17.1) (14.5 to 16.1)
Duration of sensory block (hours) 16.6±4.6 18.0±5.0 17.3±4.8 0.102
(95% CI) (15.7 to 17.5) (17.0 to 19.0) (16.4 to 18.2)
Duration of postoperative analgesia (hours) 20.0±5.7 22.7±6.0 22.0±7.4 0.006*
(95% CI) (18.9 to 21.1) (21.6 to 23.9) (20.6 to 23.4)
Vascular puncture 6 (5.0) 4 (3.3) 3 (2.5) 0.308
Paresthesia 4 (3.4) 3 (2.5) 1 (0.8) 0.200
Continuous variables are presented as mean±SD; categorical variables are presented as count (percentage). Ordinal variables (number of passes, block-related pain scores) are
presented as median (range). Onset and total anesthesia-related times are calculated only for patients with a minimal composite score of 14 points at 30 min.
*Statistically significant difference: 5 mg vs 2 mg (p=0.006).

48 Bravo D, et al. Reg Anesth Pain Med 2019;44:46–51. doi:10.1136/rapm-2018-000032


Figure 2  Percentage of patients with a minimal composite score of 14
points according to time. Absolute count values are provided on top of
each column.
since the duration of motor block cannot be accurately measured
if the blocks wear off during the patient’s sleep (approximately
20% of cases), a total of 360 patients were recruited to account
for potential dropout. Equivalence was assessed by comparing
95% CIs, and the significance of intergroup differences was
assessed by planned post-hoc comparisons (ie, each group was
compared with its adjacent dose group).
Statistical analysis was performed using SPSS Statistics for
Windows V.21. Continuous variables were analyzed with the
one-way ANOVA followed by Sidak’s test. Ordinal variables as
well as continuous data that did not follow a normal distribu-
tion were examined with the Kruskal-Wallis one-way ANOVA.
Nominal variables were analyzed with χ2 or Fisher’s exact test as
appropriate. All p values were corrected for multiple compari-
sons and those inferior to 0.05 were considered significant.
Results
The 360 subjects were recruited over a period of approximately
10.5 months (August 2017 to mid-June 2018) (figure 1). As
planned, 150, 75, 75, and 60 patients were initially enrolled
in Santiago, Montreal, Chiang Mai, and Bangkok, respectively.
However, one subject (2 mg group) rescinded his consent imme-
diately after the performance of the block. Thus his data were
not included in any subsequent analysis. Therefore demographic
characteristics (table 1) and block performance data (table 2) are
presented for a total of 359 patients.
Figure 3  Kaplan-Meier survival plot for the duration of motor block.
There were no statistical differences between any of the groups.
Bravo D, et al. Reg Anesth Pain Med 2019;44:46–51. doi:10.1136/rapm-2018-000032
Original article
Regional Anesthesia & Pain Medicine: first published as 10.1136/rapm-2018-000032 on 3 January 2019. Downloaded from file:/ on 5 February 2019 by guest. Protected by copyright.
Figure 4  Kaplan-Meier survival plot for the duration of sensory block.
There were no statistical differences between any of the groups.
Patients in the 8 mg group displayed a higher body mass index
compared with their 2 mg and 5 mg counterparts. However
there were no other intergroup differences in terms of demo-
graphic data and surgical intervention (table 1).
Technical execution (performance time/number of needle
passes/procedural pain/complications) was comparable between
the three groups (table 2). No intergroup differences were
recorded in terms of onset time, success rate, and surgical
anesthesia (table 2; figure 2). Furthermore, all three doses of
dexamethasone provided similar durations of motor block
and sensory block. However, compared with its 2 mg counter-
part, the 5 mg group resulted in longer postoperative analgesia
(22.7±6.0 vs 20.0±5.7 hours; p=0.006) (table 2; figures 3–5).
Patient follow-up at 1 week revealed sensory deficits in only
one patient. However all symptoms spontaneously resolved by
2 weeks.
Discussion
In this randomized trial, we compared 2, 5, and 8 mg of PN
dexamethasone for US-guided ICB. Our findings suggest that
all three doses provide similar durations of sensorimotor block.
Although 5 mg provided a longer analgesic duration than 2 mg,
the difference (2.7 hours) fell within our pre-established equiva-
lence margin (3.0 hours).
In the literature, randomized trials investigating intermediate
(4–5 mg) and high (7.5–8 mg) doses of PN dexamethasone in
the setting of brachial plexus blocks have reported mixed results.
For interscalene blocks, studies by Tandoc et al,2 Woo et al,26 and
Figure 5  Kaplan-Meier survival plot for the duration of analgesia.
There were no statistical differences between any of the groups.
49
 Original article
Holland et al27 have found no intergroup differences in terms of
block duration or time to first analgesia. In contrast, for supra-
clavicular blocks, Patel et al28 detected longer motor blockade
and postoperative analgesia with 8 mg compared with 4 mg of
PN dexamethasone. To date, only Woo et al26 have compared
low (2.5 mg) and intermediate (5 mg) doses of PN dexametha-
sone. These authors reported no differences in the time to first
analgesia between the two doses.26 Therefore the cumulative
results derived from the current trial as well as most previously
published studies2 26 27 seem to suggest that high doses of PN
dexamethasone provide no significant benefits compared with
their intermediate counterparts. Furthermore, intermediate and
low doses of PN dexamethasone also appear to result in similar
durations of sensorimotor block and postoperative analgesia.26
The rationale of the current trial requires discussion. In light of
the conflicting results stemming from previous studies by Tandoc
et al,2 Woo et al,26 Holland et al,27 and Patel et al,28 a practical
argument could be made to systematically administer 8 mg of PN
dexamethasone for brachial plexus blocks, thereby increasing the
odds of maximizing postoperative analgesia. However, despite
its increasing popularity,1–21 PN remains an off-label adjuvant.
Theoretical concerns of neurotoxicity may persist, as no human
study has been carried out to analyze neural injury caused by
LA combined with PN dexamethasone.29 Therefore, during the
inception phase of our trial, we reasoned that if 2 mg of PN
dexamethasone can be equivalent to 5 mg or 8 mg, it would
provide clinicians with a non-negligible 60%–75% decrease in
commonly used doses of PN dexamethasone. Furthermore, 2 mg
would also mirror the dosing recommended by Williams et al30 31
based on extrapolation of doses that are least likely to be asso-
ciated with LA-induced worsening of cytotoxicity in cultured
neurons.
The fact that we only used patients with 14-point minimal
composite scores to tabulate block duration also deserves special
mention. In our trial, 92.5%–97.5% of subjects reached 14
points (or more) at 30 min. In contrast, up to 95.8%–99.2% of
patients achieved surgical anesthesia. In theory, one could have
a sensory block with minimal motor blockade and still display
surgical anesthesia. However, since our primary outcome was
motor block duration, we elected to retain only subjects with
minimal composite scores of 14 points. This strategy mirrors the
one employed in our two previous trials investigating intrave-
nous and PN dexamethasone.18 19
Our protocol contains some limitations. First, the durations
of sensorimotor block and postoperative analgesia inherently
depend on patient recall. Therefore, in order to minimize
subjectivity, we selected motor block as the primary outcome
and discarded patients whose blocks receded during their sleep.
Second, our findings are specific to the adrenalized lidocaine
1%-bupivacaine 0.25% mixture, 35 mL injectate, and infracla-
vicular approach used in the current study. Further randomized
investigation is required for other LAs, different injectates, as
well as other approaches for brachial plexus block and other
types of nerve block. Finally, we did not record postoperative
pain scores, breakthrough opioid consumption, and opioid-re-
lated side effects. Because the trial was carried out in four centers
(across three countries), we reasoned that different patterns
of opioid prescription/consumption might have constituted a
confounding variable.
In conclusion, 2, 5 and 8 mg of PN dexamethasone provide
clinically equivalent sensorimotor and analgesic durations for
US-guided ICB. Further trials are required to compare low (ie,
2 mg) and ultra-low (eg, 0.5–1 mg) doses of PN dexamethasone
for brachial plexus blocks.
50
Regional Anesthesia & Pain Medicine: first published as 10.1136/rapm-2018-000032 on 3 January 2019. Downloaded from file:/ on 5 February 2019 by guest. Protected by copyright.
Acknowledgements  The authors thank Derek Mitchell and Andrew Owen for
their assistance with patient recruitment at the Montreal General Hospital; Alejandra
Castillo, Verónica Salinas, Ma Mercedes Aguirre and Estela Maulén for their
assistance with patient recruitment at the Hospital Clínico Universidad de Chile; as
well as Theerawat Chalachewa and Thepparat Kanchanathepsak for their assistance
with patient recruitment at Ramathibodi Hospital.
Competing interests  None declared.
Patient consent  Obtained.
Ethics approval  Ethics committee approval was obtained from Hospital Clínico
Universidad de Chile, Santiago, Chile; McGill University Health Centre, Montreal,
Canada; Maharaj Nakorn Chiang Mai Hospital, Chiang Mai, Thailand; and
Ramathibodi Hospital, Bangkok, Thailand.
Provenance and peer review  Not commissioned; externally peer reviewed
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