REGIONAL ANESTHESIA AND ACUTE PAIN
ORIGINAL ARTICLE
Perineural Versus Systemic Dexamethasone in Front-Foot
Surgery Under Ankle Block
A Randomized Double-Blind Study
Philippe Marty, MD,* Olivier Rontes, MD,* Clément Chassery, MD,* Corine Vuillaume, MD,*
Bertrand Basset, MD,* Mehdi Merouani, MD,* Constance Marquis, MD,* Benoit Bataille, MD,†
Martine Chaubard, MD,* Marie Claude Mailles, MD,* Fabrice Ferré, MD,* and Alain Delbos, MD*
Background and Objectives: Among the different adjuvants, dexa-
methasone is one of the most accepted to prolong the effect of local anes-
thetics. This study aims to determine the superiority of perineural over
systemic dexamethasone administration after a single-shot ankle block in
metatarsal osteotomy.
Methods: We performed a prospective, double-blind, randomized study.
A total of 100 patients presenting for metatarsal osteotomy with an ankle
block were randomized into 2 groups: 30 mL ropivacaine 0.375% + peri-
neural dexamethasone 4 mg (1 mL) + 2.5 mL of systemic saline solution
(PNDex group, n = 50) and 30 mL ropivacaine 0.375% + 1 mL of perineu-
ral saline solution + intravenous dexamethasone 10 mg (2.5 mL) (IVDex
group, n = 50). The primary end point was the duration of analgesia de-
fined as the time between the performance of the ankle block and the first
administration of rescue analgesia with tramadol.
Results: Time period to first rescue analgesia with tramadol was similar in
the IVDex group and the PNDex group. Data are expressed as mean (SD)
or median (range). Duration of analgesia was 23.2 (9.5)hours in the IVDex
group and 19 (8.2)hours in the PNDex group (P = 0.4). Consumption of
tramadol during the first 48 hours was 0 mg (0–150 mg) in the IVDex
group versus 0 mg (0–250 mg) in the PNDex group (P = 0.59). Four
(8%) and 12 (24%) patients reported nausea or vomiting in the IVDex
group and the PNDex group, respectively (P = 0.03).
Conclusions: In front-foot surgery, perineural and systemic administra-
tions of dexamethasone are equivalent for postoperative pain relief when
used as an adjuvant to ropivacaine ankle block.
Clinical Trial Registration: This study was registered at ClinicalTrials.
gov, identifier NCT02904538.
(Reg Anesth Pain Med 2018;43: 00–00)
O utpatient surgical procedures have boomed over the past de-
cade. This requires an efficient analgesia procedure as more
From the *Department of Anesthesia, Clinique Médipôle Garonne, Toulouse;
and †Department of Anesthesia and Intensive Care, Centre Hospitalier Nar-
bonne, France.
Address correspondence to: Philippe Marty, MD, Department of Anesthesia,
Clinique Médipôle Garonne, 31036, Toulouse, France
(e‐mail: philippemarty@hotmail.com).
Accepted for publication November 20, 2017.
The authors declare no conflict of interest.
Support was provided solely from institutional and department sources from
Department of Anesthesiology, Clinique Médipôle Garonne,
Toulouse, France.
This work should be attributed to the Department of Anesthesiology, Clinique
Médipôle Garonne, Toulouse, France.
Authors' contributions: O.R., B.Basset, C.V., and M.C.M. performed all regional
anesthesia. P.M. and F.F. wrote the manuscript. C.M., M.M., and M.C.
participated in the design of the study. B.Bataille performed the statistical
analysis. A.D. participated in its design and coordination and helped to draft
the manuscript. All authors read and approved the final manuscript.
Copyright © 2018 by American Society of Regional Anesthesia and Pain
Medicine
ISSN: 1098-7339
DOI: 10.1097/AAP.0000000000000769
Regional Anesthesia and Pain Medicine • Volume 43, Number 5, July 2018
Copyright © 2018 American Society of Regional Anesthesia and Pain Medicine. Unauthorized reproduction of this article is prohibited.
than 30% of patients present a moderate to severe pain in the first
24 hours after ambulatory surgery.1 In forefoot surgery, a recent
study reported that 80% of patients experienced pain in the first
postoperative hours, and more than 30% experienced nausea.2
Compared with oral analgesia, regional anesthesia is associated
with better pain relief, less opioid consumption, and less nausea
and vomiting.3,4 In order to prolong the effect of local anesthetics
(LAs), a number of strategies have been investigated, such as the
use of continuous perineural catheters. Although effective, these
catheters themselves bring along potential risks (eg, infection, de-
layed mobilization, increased nursing costs) and can be challeng-
ing in the setting of ambulatory surgery.5–7 To avoid these pitfalls,
adjuvants have been tested to prolong the duration of postopera-
tive analgesia. Among the different adjuvants, dexamethasone is
one of the most accepted to prolong the effect of LAs. Perineural
administration was the first route tested, and its effectiveness has
been clearly reported.8–10 Systemic administration of dexametha-
sone in combination with LA was also tested and resulted in a pro-
longed postoperative analgesia duration compared with regional
anesthesia alone.11 The next step is to determine whether a systemic
or a perineural route is the most effective for postoperative analge-
sia. This point is still a matter of debate and controversy.12,13
In patients having an ankle block for metatarsal osteotomy,
this study aims to determine if perineural dexamethasone com-
pared with systemic dexamethasone reduces analgesic requirements
during the postoperative period.
METHODS
The trial was registered at ClinicalTrials.gov (NCT02904538).
Oversight and study approval were provided by the Committee for
Protection of Human Subjects (South East 6, Clermont-Ferrand,
France; institutional review board no. IRB00008526).
Patients
This prospective, randomized, double-blind study was con-
ducted in the Orthopedics Department of Clinique Médipôle Ga-
ronne. Patients were included from November 2016 to May 2017.
All patients scheduled for ambulatory metatarsal osteotomy were
screened for inclusion in the study. We have chosen a specific sur-
gical procedure to ensure reproducible postoperative pain man-
agement. Exclusion criteria were as follows: refusal to participate,
age younger than 18 years, preexisting neuropathies, systemic
glucocorticoid therapy within 24 hours of the surgery, pregnancy,
routine use of opioid medications, intolerance for 1 or more med-
ications of the study protocol, and diabetes.
Study Design
At patient arrival in the anesthetic room, the research assis-
tant checked the patient's consent. Using a computer-generated
1
Marty et al Regional Anesthesia and Pain Medicine • Volume 43, Number 5, July 2018
random-number table, patients were randomized in 2 treatment
groups by resource not part of the study:
(1) PNDex group = 30 mL ropivacaine 0.375% + perineural
dexamethasone 4 mg (1 mL) + 2.5 mL of systemic saline solution
(1) IVDex group = 30 mL ropivacaine 0.375% + 1 mL of perineural
saline solution + intravenous dexamethasone 10 mg (2.5 mL)
Medication was prepared by a staff member who was not in-
volved in the study and delivered in unidentifiable syringes.
Premedication (midazolam 1 mg) was administered 5 minutes
before the regional anesthesia procedure. The patient was monitored
with electrocardiography, pulse oximetry, and noninvasive arterial
pressure. An experienced anesthetist performed the ankle block.
All regional anesthesia procedures were guided by ultra-
sound (SonoSite Export, 8- to 12-MHz linear probe; SonoSite,
Bothell, Washington) using a 50-mm sonovisible nerve block nee-
dle (Ultraplex; B. Braun, Melsungen, Germany).
Ankle block was performed as previously described14,15:
• The tibial nerve was visualized immediately posterior to the
posterior tibial artery, at the malleolar level. Five to 7 mL of
LA solution was injected.
• For the saphenous nerve, the probe was placed anterior to the
internal malleolus, and 3 to 5 mL of LA was injected close to
the long saphenous vein. The deep peroneal nerve was visual-
ized at the anterior face of the ankle, in close proximity to an-
terior tibial artery. Five to 7 mL of LA solution was injected
around the nerve.
• The superficial peroneal nerve was located superficial to the
fibular bone. Five to 7 mL of LA solution was injected. The
sural nerve was visualized lateral to the Achilles tendon, in
close proximity to sural vein. Three to 5 mL of LA solution
was injected.
The patient was then transferred to the operating room. Pa-
tients had, at their disposal, an electronic device to play the music
of their choice and were able to ask for sedative medication if nec-
essary. A tourniquet was placed at the ankle level and inflated dur-
ing the surgery (250 mm Hg). Only patients with metatarsal
osteotomy were included (either a distal or a proximal metatarsal
osteotomy). Frequently, the procedure included other surgeries
(tendon resection, phalanx osteotomy, or neurectomy).
The patient was then transferred to the postanesthesia care
unit. Paracetamol (1 g each 6 hours) and ketoprofen (100 mg
twice a day) were systematically administered in all groups. Res-
cue analgesia with tramadol (100 mg each 8 hours) was adminis-
tered if necessary (verbal rating scale [VRS] >3). Recovery room
discharge criteria were stable vital parameters, absence of nausea
and vomiting, and a pain VRS of less than 3. Hospital discharge
was planned 8 hours after surgery. All adverse effects were col-
lected. A phone call was scheduled 3 days after surgery to evaluate
pain using a VRS, consumption of tramadol tablets, adverse ef-
fects, and overall satisfaction. Patients were instructed to keep a
diary or write down a time when they took painkillers.
Sample Size Considerations
Based on our experience with ropivacaine 0.375%, we as-
sumed a duration of analgesia of 1320 minutes with an SD of
360 minutes in the PNDex group. A difference of 240 minutes be-
tween the treatment and the control group was considered clini-
cally relevant, and a sample size (power 90% and α = 0.05%) of
48 patients per group was calculated (2-sample t test). To correct
for failed blocks and patient dropout, 50 patients per group were
included in the study.
2 © 2018 American Society of Regional Anesthesia and Pain Medicine
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Statistical Analysis
The primary end point was the duration of analgesia defined
as the time between the performance of the ankle block and the
first administration of rescue analgesia with tramadol. Secondary
outcomes were pain scores, analgesic need, nausea, adverse ef-
fects, and overall satisfaction. Descriptive statistics were used to
present baseline characteristics for the 2 groups. The normality
of the quantitative data was verified using a Kolmogorov-Smirnov
test and expressed as mean ± SD or median (range) according to
their distribution. Quantitative variables were compared using Stu-
dent t test or Mann-Whitney U test according to the normality of their
distribution. Categorical variables were assessed using Fisher exact
test. The interval between the performance of the ankle block and
the initial use of rescue analgesia was analyzed by Kaplan-Meier sur-
vival analysis in accordance with the censured nature of the depen-
dent variable and proportionality of the hazard ratio and compared
between groups with log-rank test or Tarone-Ware test if appropriate.
The primary analysis was the comparison between survival curves.
All other statistical tests were secondary and performed at the
5% significance level. Statistical analysis was performed using
Stata SE 11.1 software (StataCorp LP, College Station, Texas).
RESULTS
Patient Characteristics
From November 2016 to May 2017, 123 patients scheduled
for ambulatory metatarsal osteotomy were screened for inclusion
in the study. Twenty-three patients were ineligible because of ex-
clusion criteria or refusal to participate, and a total of 100 patients
were prospectively enrolled and completed the study successfully
(intention-to-treat analysis). Flowchart is shown in Figure 1. No
patient reported failure of regional anesthesia, and no general an-
esthesia was required in any patient in either group. Patient char-
acteristics are similar in both groups (Table 1).
Primary Outcome
Time period to first rescue analgesia with tramadol was sim-
ilar in the IVDex group and the PNDex group. Mean duration of
analgesia was 23.2 (SD, 9.5)hours in the IVDex group and 19
(SD, 8.2)hours in the PNDex group (P = 0.4) (Table 2). Kaplan-
Meier curves for the first analgesic request with patients not
receiving any analgesics after 48 hours are presented in Figure 2.
No significant difference between these curves (log-rank test)
was observed (P = 0.403).
Secondary Outcomes
Median consumption of tramadol during the first 48 hours
was 0 mg (range, 0–150 mg) in the IVDex group versus 0 mg
(range, 0–250 mg) in the PNDex group (P = 0.59). Thirty patients
(60%) in the IVDex group and 35 patients (70%) in the PNDex
group did not require tramadol during the first 48 hours
(P = 0.29). Maximum pain reported during the first 48 hours
was similar in both groups: 2 (range, 1–5) in the IVDex group ver-
sus 2 (range, 1–4) in the PNDex group (P = 0.25). A lower inci-
dence of patients reporting nausea or vomiting was reported in
the IVDex group than in the PNDex group: 4 (8%) versus 12
(24%), respectively (P = 0.03). No patient complained of neuro-
logical symptoms associated with regional anesthesia in any of
the groups (Table 2).
DISCUSSION
We identified the clinical analgesic equivalence of perineural
and systemic dexamethasone after ankle block with ropivacaine
Regional Anesthesia and Pain Medicine • Volume 43, Number 5, July 2018 Front-Foot Surgery Under Ankle Block

FIGURE 1. Randomization and follow-up of patients.

for metatarsal osteotomy. We observed a relatively long duration
of analgesia (approximately 20 hours) in both groups. This result
extends the knowledge of the benefit of adding dexamethasone
for the management of postoperative pain in the setting of front-
foot surgery under regional anesthesia.
Ankle block allows intraoperative management as well as
postoperative pain relief. Both perineural and systemic routes of
dexamethasone provide similar postoperative pain control with
an extremely low consumption of tramadol. Indeed, approximately
two-thirds of patients did not require tramadol consumption, making
the superiority of a route of administration more difficult to
demonstrate. This latter result could explain why we did not ob-
serve a clinically significant difference between intravenous and
perineural dexamethasone on analgesic duration. Although this
surgery was traditionally considered painful, the advent of ankle
block with the addition of dexamethasone (whatever the route of
administration) could revive the debate about the interest of con-
tinuous sciatic nerve blocks in front-foot surgery.
The equivalence of perineural or systemic administration of
dexamethasone as adjuvant to ropivacaine 0.375% is a controver-
sial issue. Recent meta-analysis reported longer duration of anal-
gesia associated with perineural administration of dexamethasone.13

TABLE 1. Demographic Characteristics

IVDex Group (n = 50) PNDex Group (n = 50) P

Female 43 (86%) 46 (92%) 0.52
Age, y 65 (12) 66 (13) 0.66
Body mass index, kg/m2 21 (2) 21 (3) 0.75
Failed blocks 0 (0) 0 (0) 1
Length of surgery, min 31 (8) 33 (7) 0.38
Delay between the completion of RA and incisure, min 33 (10–55) 42 (10–62) 0.31
Values are expressed as mean (SD), median (range), or n (%).
RA indicates regional anesthesia.

© 2018 American Society of Regional Anesthesia and Pain Medicine 3

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Marty et al Regional Anesthesia and Pain Medicine • Volume 43, Number 5, July 2018

TABLE 2. Intraoperative and Postoperative Management

Intraoperative Management IVDex Group (n = 50) PNDex Group (n = 50) P

Intraoperative conversion to general anesthesia 0 (0%) 0 (0%) 1
Doses of sedative request during surgery
Midazolam, mg 0 (0–1) 0 (0–1) 0.37
Sufentanil, μg 0 (0–0) 0 (0–0) 1
Ketamine, mg 5 (0–10) 5 (0–5) 0.14
Postoperative pain management
Time period to first rescue analgesia with tramadol, h 23.2 (9.5) 19 (8.2) 0.4
Tramadol consumption during the first 48 h, mg 0 (0–150) 0 (0–250) 0.59
Patients not requiring tramadol during the first 48 h 30 (60%) 35 (70%) 0.29
Maximum pain reported during the first 48 h (VRS) 2 (1–5) 2 (1–4) 0.25
Patients reporting nausea or vomiting 4 (8%) 12 (24%) 0.03
Values are expressed as mean (SD), median (range), or n (%).

However, the dose of dexamethasone administered has to be con-
sidered to analyze the superiority of perineural route.16 Previous
randomized double-blind studies reported equivalence of perineu-
ral and systemic routes using high systemic dexamethasone dose
(>8 mg) when added to long-acting LAs.17,18 Other previous ran-
domized double-blind studies reported superiority of perineural
route when using low systemic dexamethasone dose (<8 mg).19,20
In this controversial topic, evidence based on well-designed stud-
ies should be considered. Future studies investigating the dosage
response of systemic and perineural dexamethasone are war-
ranted. Moreover, the exact mechanism of action by which dexa-
methasone prolongs the duration of analgesia of LAs remains to
be defined, and our current work does not add mechanistic infor-
mation. Had we measured blood levels of dexamethasone, we
could have better determined whether the dexamethasone added
to the ankle block was acting by a local neural mechanism versus
a systemic effect.
In foot surgery, Dawson et al18 previously compared sys-
temic and perineural routes for dexamethasone administration as
adjuvant to ropivacaine 0.75%. This study presented several pit-
falls that we attempted to correct. First, this trial reported use of
a very high concentration of ropivacaine, which is known to be as-
sociated with neurotoxicity.21 Our study presented similar results
regarding postoperative pain with a lower concentration of ropivacaine
(0.375%). Second, we tried to define a more reliable primary ob-
jective as time to first request for analgesic versus movement as
used by Dawson et al.18
Interestingly, the only difference we observed between
IVDex and the PNDex groups was the incidence of nausea or
vomiting. The effectiveness of systemic dexamethasone on the

FIGURE 2. Kaplan-Meier survival plot.

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Regional Anesthesia and Pain Medicine • Volume 43, Number 5, July 2018
prevention of nausea and vomiting is well known and has been
previously described.22
To ensure reproducible postoperative pain intensity, we have
chosen to include only patients with metatarsal osteotomy. Pa-
tients with tendon surgery and/or neurectomy surgery, without
metatarsal osteotomy, were excluded from the study. These results
have to be interpreted with caution in other types of surgery.
This study presents several limitations. First, its monocentric
design implies that these results need to be confirmed in a larger
multicentric trial. Second, this study, which suggests equivalence
of perineural and systemic route (using high systemic dexametha-
sone dose), may not be reproducible with other surgical or re-
gional procedures. We may have been significantly underpowered
to detect a difference between groups because of the unexpected
minimal pain that patients experienced in the setting of foot sur-
gery with a ropivacaine ankle block. Third, we decided to use dif-
ferent perineural and systemic doses of dexamethasone. This
makes the results interpretation challenging. However, based on
previous findings, we decided to compare the supposed optimal
ceiling dose of both perineural and systemic dexamethasone that
prolongs analgesia duration.23–25 Finally, our study was not de-
signed to assess neural toxicity of dexamethasone. There is a lack
of data regarding this complex issue. Recent studies do not sup-
port any evidence of neural toxicity of dexamethasone when ad-
ministered perineurally.26,27 However, these experimental results
need to be confirmed before extending the routine use of perineu-
ral administration to humans.
CONCLUSIONS
In front-foot surgery, 8 mg of systemic dexamethasone is equiv-
alent to perineural dexamethasone (4 mg) in prolonging the anal-
gesic duration of an ankle block with ropivacaine 0.375%. Given
that we observed a protective effect against nausea or vomiting
using the systemic route, clinicians may want to favor the sys-
temic route given the possibility for increased risk of neurotoxic-
ity of perineural dexamethasone.
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