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Parecoxib sodium in the treatment of

postoperative pain after Lichtenstein tensionfree mesh inguinal hernia repair
Article in Hernia October 2010
Impact Factor: 2.05 DOI: 10.1007/s10029-010-0737-1 Source: PubMed

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Hernia
DOI 10.1007/s10029-010-0737-1

O R I G I N A L A R T I CL E

Parecoxib sodium in the treatment of postoperative pain

after Lichtenstein tension-free mesh inguinal hernia repair
A. V. Kyriakidis I. Perysinakis I. Alexandris
K. Athanasiou Ch. Papadopoulos I. Mpesikos

Received: 26 February 2010 / Accepted: 3 October 2010

Springer-Verlag 2010

Abstract
Purpose This prospective, randomized, double-blind study
compared the analgesic eYcacy and safety of parecoxib
sodium versus lornoxicam and diclofenac, after Lichtenstein
tension-free mesh inguinal hernia repair.
Methods Patients were randomly assigned to receive
parecoxib 80 mg daily i.v. (Group A), lornoxicam 16 mg
daily i.v. (Group B) or diclofenac 150 mg daily i.m. (Group
C). Rescue analgesia in all groups consisted of pethidine
25 mg i.m. Pain was measured with an analogue scale (pain
intensity score).
Results Patients treated with parecoxib 80 mg reported
signiWcantly lower summed pain intensity scores compared
with lornoxicam and diclofenac-treated patients. Duration
of analgesia was also signiWcantly longer with parecoxib
than with lornoxicam and diclofenac. Adverse events were
signiWcantly less common in the parecoxib and lornoxicam
group, compared with diclofenac group.
Conclusions Multiple-day administration of parecoxib
40 mg twice daily is more eVective than equivalent doses of
lornoxicam and diclofenac, and generally better tolerated
than diclofenac after Lichtenstein tension-free mesh inguinal hernia repair.
Keywords Parecoxib NSAIDs
Postoperative analgesia Hernia repair
A. V. Kyriakidis (&) I. Perysinakis I. Alexandris
K. Athanasiou
Surgical Department, General Hospital of AmWssa,
Frouriou 95, AmWssa 33100, Greece
e-mail: alkidi@hotmail.com
Ch. Papadopoulos I. Mpesikos
Department of Anesthesiology,
General Hospital of AmWssa, AmWssa, Greece

Introduction
EVective postoperative pain control requires an analgesic
with rapid onset and long duration of action. Opioids, such
as pethidine, are satisfactory regimens but their use is frequently accompanied by adverse eVects, such as respiratory
depression, nausea, vomiting, constipation, urinary retention, decreased blood pressure and sedation, thus leading to
slower patient recovery [1]. Non-steroidal anti-inXammatory drugs (NSAIDs) have an opioid sparing eVect when
used postoperatively, but they tend to show a slower onset
of action [2, 3]. Diclofenac and lornoxicam have been
widely used for this purpose. The arrival of speciWc COX-2
inhibitors, such as parecoxib, was very promising as far as
adverse eVects were concerned, but their eVectiveness in
comparison with non-speciWc inhibitors has yet to be determined. Several studies have been published for this purpose, most of which claim that speciWc COX-2 inhibitors
are at least as eVective as non-speciWc ones [47]. The aim
of our study was to evaluate the eYcacy of a speciWc COX2
inhibitor, parecoxib, compared with two non-speciWc NSAIDs, lornoxicam and diclofenac, in patients undergoing
Lichtenstein tension-free mesh inguinal hernia repair. The
primary end-point was the diVerence between groups in
pain scores. Secondary end-points were the need for rescue
analgesia and adverse eVects.

Patients and methods

This prospective, randomized, double-blind study was conducted in accordance with good clinical practice and the
Declaration of Helsinki. An Institutional Review Board
approved the protocol. All patients gave written, informed
consent. Inclusion criteria were the following: patients

123

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between the ages of 18 and 75 and ASA physical status

III. Patients with a history of signiWcant cardiac, pulmonary, hepatic, or renal disease, body mass index <19 or >35,
chronic drug or alcohol abuse, and contraindications or previous adverse reaction to any of the drugs used in the study
were excluded. Not included were females with a positive
pregnancy test and patients unable to cooperate. A total of
510 eligible patients who underwent Lichtenstein tensionfree mesh inguinal hernia repair in the General Hospital of
AmWssa from January 2003 to April 2009. were included in
this study
Patients were assigned randomly to one of three study
groups. The three study groups were: (1) parecoxib sodium
40 mg i.v. perioperatively and parecoxib sodium 40 mg i.v.
twice a day as postsurgical analgesia (n = 260), (2) lornoxicam 8 mg i.v. perioperatively and lornoxicam 8 mg i.v
twice a day (n = 140), (3) diclofenac 75 mg i.m. perioperatively and diclofenac 75 mg i.m. twice a day (n = 110).
Rescue analgesia consisted of pethidine 25 mg i.m. Both
patients and investigators were blinded to treatment. All
patients were followed for 2 days and were discharged the
second postoperative day.
Parenteral administration of the three NSAIDs was preferred over per os administration for the following reasons:
parenetral administration has been associated with 30% less
gastric toxicity than per os administration and oVers
quicker therapeutic eVect. Furthermore, all postoperative
patients have an intravenous cannula inserted. Comparison
of intravenous with intramuscular administration was
unavoidable, given that diclofenac must not be administered intravenously.
Maximum daily doses of all three drugs (parecoxib
80 mg/24 h, lornoxicam 16 mg/24 h, and diclofenac
150 mg/24 h) were administered according to the Hellenic
National Organization for Medicines, in order to ensure
equivalency between them and similar serum levels.
Assessment of pain was made by a pain scale provided
by the British Pain Society (pain intensity score, PIS).
Patients were asked how intense and distressing their pain
was, how much their pain interfered with their normal
everyday activities and how much had the treatment
relieved (taken away) the pain. Pain was measured with a 0
to 10 analogue scale, 8 h postoperatively and in the morning of the Wrst postoperative day. If the pain intensity score
was over 4, pethidine 25 mg i.m. was administered. All
patients were assessed for postoperative adverse eVects,
such as decreased blood pressure, respiratory depression,
vomiting and nausea, as well as adverse eVects connected
with NSAIDS, such as hypertension, renal dysfunction and
gastrointestinal disorders.
Statistical analysis was performed using t-test for numerical variables and chi-square test for categorical variables.

123

The level of statistical signiWcance was set at 5%

(P < 0.05).

Results
A total of 513 patients (262 patients in the parecoxib group,
141 in the lornoxicam group and 110 in the diclofenac
group) were included from January 2003 to April 2009.
Three patients refused to comply with the protocol until the
end of the follow-up. Therefore, 510 patients received the
study medications. Completion status and reasons for leaving the study are shown in Fig. 1.
Demographic data and procedure duration are presented
in Table 1. The three groups were similar with respect to
gender, age, height, weight, body mass index, ASA physical status, and duration of surgery. Eighteen patients had
recurrent hernia and 48 patients had scrotal hernia. No femoral hernias were included in this cohort of patients.
The results of our study are presented in Tables 2, 3, 4,
5, 6 and 7. The level of analgesia was signiWcantly better
with parecoxib than with lornoxicam (P < 0.01) and diclofenac (P < 0.001) 8 h postoperatively as well as in the
morning of the Wrst postoperative day (P < 0.05 and
P < 0.001, respectively). Furthermore, lornoxicam had a
better analgesic eVect than diclofenac, both 8 h postoperatively and on post-op day 1 (P < 0.05). Mean PIS in Groups
A, B and C are shown in Tables 2, 3 and 4.
Duration of analgesia was signiWcantly diVerent between
the three groups. Mean duration was 11 h in Group A, 8 h
in Group B and 6 h in Group C. The diVerences between
groups A and B, B and C as well as A and C were statistically all very signiWcant (Tables 2, 3, 4).
The percentage of patients needing additional analgesia
was 3.1% in Group A (8 patients), 13.6% in Group B (19
patients) and 32.7% in Group C (36 patients) (Tables 2, 3, 4).
The prevalence of side eVects in each analgesic regimen
is presented in Tables 5, 6 and 7. The overall rates of side
eVects were 4.2% for parecoxib, 5% for lornoxicam and
20% for diclofenac. The diVerence between parecoxib and
lornoxicam was not statistically signiWcant (P > 0.1), while
both diVered signiWcantly from diclofenac (P < 0.001).
Side eVects connected with NSAIDS were observed in
11 patients from Group A (4.2%), 6 patients from Group
B (4.3%) and 18 patients from Group C (16.4%). Similarly, the diVerence between parecoxib and lornoxicam
was not statistically signiWcant (P > 0.05), while both
diVered signiWcantly from diclofenac (P < 0.001). Side
eVects caused by the use of the three study medications
were: slightly impaired renal function (6 patients), mild
hypertension (7 patients) and gastrointestinal disorders
(22 patients).

Hernia

Fig. 1 Patient Xow chart

Table 3 Comparison of eVectiveness, duration and adequacy of analgesia in Groups B and C

Table 1 Demographic data and duration of surgery

Group
A (n = 260) B (n = 140)

C (n = 110)

Gender (male/female)

187/73

86/24

Age (year)

48.5 11.2 49.5 11

Height (cm)

172.2 9.2 173.6 8.1 171.7 8.9

Weight (kg)

77.1 11.1 75.7 10.8 76.1 10.7

Body mass index (kg/m2) 26.2 2.9

102/38

46.9 10.8

25.9 2.9

26 2.8

ASA physical status I/II

78/182

42/98

34/76

Duration of surgery (min)

47.6 5

48.1 4.9

47.8 5.1

Data are shown as mean SD or number of patients as appropriate

Table 2 Comparison of eVectiveness, duration and adequacy of analgesia in Groups A and B

PIS

Parecoxib Lornoxicam T value SD

8-h

1.8

2.2

Post-op day 1

1.5

1.8

Mean duration
of analgesia (h)

11

Number of patients 8 (3.1%)

requiring pethidine
PIS Pain intensity score

19 (13.6%)

2.71 1.32 <0.01

2.25 1.23 <0.05
14.5

PIS

Lornoxicam Diclofenac T value SD P

8-h

2.2

2.6

Post-op day 1

1.8

2.2

Mean duration
of analgesia (h)

2.12 1.42 <0.05

2.24 1.29 <0.05
7.7

1.95 <0.001

Number of patients 19 (13.6%) 36 (32.7%)

requiring pethidine

Table 4 Comparison of eVectiveness, duration and adequacy of analgesia in Groups A and C

PIS

Parecoxib Diclofenac T value SD

8-h

1.8

2.6

Post-op day 1

1.5

2.2

Mean duration
of analgesia (h)

11

Number of patients 8 (3.1%)

requiring pethidine

4.74 1.53 <0.001

4.34 1.49 <0.001
21.9

1.94 <0.001

36 (32.7%)

1.98 <0.001

Opioid-related side eVects were reported only in

Groups B and C (0.7 and 3.6%, respectively). These were
nausea and vomiting in 1 patient of Group B and four

123

Hernia
Table 5 Comparison of adverse eVects of the analgesic regimens A
and B
Parecoxib

Lornoxicam

2 value

0.08

>0.1

0.001

>0.1

0.31

>0.1

Total adverse eVects

Yes

11 (4.2%)

7 (5%)

No

249 (95.8%)

133 (95%)

Adverse eVects of NSAIDS

Yes

11 (4.2%)

6 (4.3%)

No

249 (95.8%)

134 (95.7%)

Adverse eVects of opioids

Yes

0 (0%)

1 (0.7%)

No

260 (100%)

139 (99.3%)

Table 6 Comparison of adverse eVects of the analgesic regimens B

and C
Lornoxicam

Diclofenac

2 value

13.52

<0.001

10.35

<0.01

1.4

>0.1

Total adverse eVects

Yes

7 (5%)

22 (20%)

No

133 (95%)

88 (80%)

Adverse eVects of NSAIDS

Yes

6 (4.3%)

18 (16.4%)

No

134 (95.7%)

92 (83.6%)

Adverse eVects of opioids

Yes

1 (0.7%)

4 (3.6%)

No

139 (99.3%)

106 (96.4%)

NSAIDS Non-steroidal anti-inXammatory drugs

Table 7 Comparison of adverse eVects of the analgesic regimens A

and C
Parecoxib

Diclofenac

2 value

15.99

<0.001

10.64

<0.01

<0.05

Total adverse eVects

Yes

11 (4.2%)

22 (20%)

No

249 (95.8%)

88 (80%)

Adverse eVects of NSAIDS

Yes

11 (4.2%)

18 (16.4%)

No

249 (95.8%)

92 (83.6%)

Adverse eVects of opioids

Yes

0 (0%)

4 (3.6%)

No

260 (100%)

106 (96.4%)

patients of Group C, and decreased blood pressure in one

patient of Group C (BP = 92/58 mmHg). Nausea and
vomiting were treated with metoclopramide IV, and hypotension with rapid infusion of crystalloids. The only statistically signiWcant diVerence was that between Group A
and C (P < 0.05).

123

Discussion
In 1971, Vane showed that the analgesic action of traditional NSAIDs relies on inhibition of the cyclo-oxygenase
(COX) enzyme, which in turn results in reduced synthesis
of proalgesic prostaglandins [8]. Two decades later, COX
was shown to exist as two distinct isoforms [9, 10]. COX1,
which is constitutively expressed as a housekeeping
enzyme in nearly all tissues, and mediates physiological
responses (e.g., cytoprotection of the stomach, platelet
aggregation); and COX2, which is responsible for the synthesis of prostanoids involved in pathological processes, such
as acute and chronic inXammatory states. In fact, predominantly COX2-dependent prostaglandins sensitize peripheral
nociceptors and act in the spinal cord to produce central
hyperalgesia [11]. COX2 is also involved in many adaptive
processes, such as regulation of blood pressure, kidney
function, and ulcer and wound healing.
Many of the adverse eVects of NSAIDs (e.g., gastrointestinal ulceration and bleeding, platelet dysfunction) have
been associated with a suppression of COX1-derived prostanoids, whereas inhibition of COX2-derived prostanoids
mediates the anti-inXammatory, analgesic, and antipyretic
eVects of these compounds. In consequence, the hypothesis
that selective inhibition of COX2 might have therapeutic
actions similar to those of traditional NSAIDs, but cause
fewer unwanted drug eVects, was the rationale for the
development of selective COX2 inhibitors.
The hypothesis that COX2 inhibitors provide an
improved risk proWle in terms of gastrointestinal safety as
compared with NSAIDs was tested in three large phase III
clinical trials that included a total of approximately 35,000
patients. Two of them conWrmed this hypothesis [12, 13],
but in the third one a signiWcant beneWcial eVect of the
COX2 inhibitor was evident only when the deWnition of
upper gastrointestinal endpoints was expanded to include
symptomatic ulcers [14]. An alternative therapeutic approach
to COX2 inhibitors is co-therapy with proton-pump inhibitors, which can prevent peptic ulcers in high-risk patients
using NSAIDs [15, 16]. This combination, however, does
not provide protection against damage caused by NSAIDs
in the lower gastrointestinal tract.
COX2 inhibitors have been associated with an increased
incidence of cardiovascular adverse eVects [1721]. As a
whole, six placebo-controlled trials have established that
COX2 inhibitors confer a cardiovascular risk, which manifests as myocardial infarction, stroke, and congestive heart
failure. Current recommendations suggest that an assessment of the risk of thrombotic events should be performed
for patients in whom COX2 inhibitors are being considered
for postoperative pain management [22].
Several studies have shown that parecoxib is a potent
analgesic for the control of postoperative pain after several

Hernia

types of surgical procedures. Viscusi et al. compared the

analgesic eYcacy and safety of two dosing regimens of
parecoxib versus placebo after total hip arthroplasty. The
author came to the conclusion that multiple-day administration of parecoxib 20 mg once or twice daily is eVective and
generally well tolerated after total hip arthroplasty [23].
Joshi et al. [24] evaluated the analgesic and opioid-sparing eYcacy of a preoperative dose of IV parecoxib followed by oral valdecoxib in treating pain associated with
elective laparoscopic cholecystectomy and concluded that
preoperative parecoxib is a valuable opioid-sparing adjunct
to standard opioid treatment of pain after laparoscopic cholecystectomy and that subsequent treatment with oral valdecoxib extends this beneWt in a clinically meaningful
manner.
In 2006, Papadima et al. conducted a prospective randomized placebo-controlled trial, comparing the eYcacy of
lornoxicam versus parecoxib for the management of postoperative pain. The authors concluded that parecoxib
40 mg and lornoxicam 8 mg were equianalgesic for the
management of pain after laparoscopic cholecystectomy
[25].
Tang et al. [26] assessed the analgesic eYcacy and side
eVect proWle of parecoxib in patients undergoing major
gynecological surgical procedures. According to this study,
intravenous parecoxib (20 or 40 mg) was eVective in
decreasing the patient-controlled analgesia (PCA) opioid
requirement after lower abdominal surgical procedures.
However, it failed to improve pain management or reduce
opioid-related side eVects in the early postoperative period.
Nussmeier et al. [27] suggested that parecoxib and its
oral form, valdecoxib, are useful adjuncts to opioids for the
treatment of postoperative pain in noncardiac surgical
patients, but further study will be required to determine the
safety proWle of parecoxib and valdecoxib administered to
patients with known atherosclerotic disease after noncardiac surgery.
Beaussier et al. [28] compared parecoxib with proparacetamol after inguinal hernia repair. Their data showed that,
within the Wrst 12 h after inguinal hernia repair, a single
parenteral injection of parecoxib 40 mg compares favorably
with two injections of propacetamol 2 g.
In 2004, Kranke et al. performed a systematic review,
including full reports of randomized comparisons of parecoxib compared with any other analgesic intervention for
prophylaxis or treatment of postoperative pain. The results
suggested a favorable proWle for parecoxib compared with
inactive or active controls (morphine, ketorolac, placebo),
without determining the optimal dose, timing, and frequency of administration [29].
Apart from analgesic drugs, postoperative analgesia
after inguinal hernia repair can be enhanced by other
means. Wound inWltration with local anesthetics such as

ropivacaine results in lower postoperative pain scores,

delays the requirement for additional analgesics, and allows
earlier patient discharge [30]. Aasb et al. [31] suggest that
preoperative inguinal Weld block for hernia repair provides
beneWts for patients in terms of faster recovery, less pain,
better mobilization and higher satisfaction throughout the
whole Wrst postoperative week, compared with general
anesthesia and wound inWltration. Harrison et al. [32] have
shown that the combination of nerve block and wound inWltration reduces consumption of morphine in the Wrst 24 h
after herniorrhaphy. Vintar et al. placed an epidural catheter
in the surgical wound and connected it to a balloon-pump
containing either 0.25% bupivacaine or 0.25% ropivacaine.
Postoperatively, the patient self-administered the local
anesthetic into the wound. The authors concluded that selfadministration of the local anesthetic solution via a catheter
in the surgical wound is an eVective method of pain relief
after inguinal hernia repair with few side-eVects [33].
Our data showed that parecoxib is more eYcacious than
lornoxicam and diclofenac in terms of level and duration of
analgesia, as well as in reducing the percentage of patients
requiring opioid administration. Furthermore, no upper
gastrointestinal clinical events and signiWcantly fewer opioid-related side eVects (respiratory depression, nausea,
vomiting and decreased blood pressure) were observed
with parecoxib. As far as cost is concerned, parecoxib
40 mg is the most expensive medication of the three tested
here, as each ampoule costs 5D. Lornoxicam 8 mg and diclofenac 75 mg cost 1.83D and 0.29D/ampoule, respectively.
In conclusion, parecoxib, although more expensive, is more
eYcacious than lornoxicam and diclofenac, and generally
better tolerated than diclofenac, in the treatment of postoperative pain after Lichtenstein tension-free mesh inguinal
hernia repair.
ConXict of interest

None.

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