British Journal of Anaesthesia 97 (6): 858–61 (2006)

doi:10.1093/bja/ael249 Advance Access publication September 13, 2006

A prospective, double-blind, randomized trial of caudal block

using ropivacaine 0.2% with or without fentanyl
1 mg kg 1 in children
Y. Kawaraguchi1 *, T. Otomo1, C. Ota1, N. Uchida1, A. Taniguchi1 and S. Inoue2
1
Department of Anaesthesia and Critical Care, Miyagi Children’s Hospital, Sendai, Japan.
2
Department of Anaesthesiology, Nara Medical University, Kashihara, Japan
*Corresponding author: Department of Anaesthesiology, Nara Medical University, 840, Shijo-cho,
Kashihara, Nara, 634-8522, Japan. E-mail: kawaraguchi@bea.hi-ho.ne.jp
Background. It has been reported that ropivacaine produces vasoconstriction in contrast
to vasodilation produced by bupivacaine. It is possible that additives to ropivacaine can
provide further analgesic advantages compared with bupivacaine. We thus evaluated whether
the addition of fentanyl to ropivacaine prolonged the duration of analgesia after a single shot
caudal block.
Methods. A total of 36 children undergoing surgical procedures below the umbilicus were
randomly allocated to one of two groups: Group F received ropivacaine 0.2%, 1 ml kg 1 with
fentanyl 1 mg kg 1 and Group S received ropivacaine 0.2%, 1 ml kg 1 with saline. The analgesic
effect of the caudal block was evaluated using the Children’s Hospital of Eastern Ontario Pain
Scale (CHEOPS) and sedation was assessed using the Steward score at 30 min after extubation
and at 1, 2, 4, 6, 12 and 24 h. The first analgesic requirement time and side-effects in a 24 h period
were also recorded.
Results. There were no differences in characteristics between the groups. The end-tidal con-
centration of sevoflurane at extubation in Group F was significantly lower than in Group S.
However, there was no significant difference in time from discontinuation of the volatile anaes-
thetics to tracheal extubation. No statistical differences were found in the CHEOPS and Steward
score, and the time to first analgesia. The incidence of postoperative vomiting was not significantly
different.
Conclusion. We found that the addition of fentanyl 1 mg kg 1 to ropivacaine 0.2% for caudal
analgesia provides no further analgesic advantages over ropivacaine 0.2% alone.
Br J Anaesth 2006; 97: 858–61
Keywords: analgesia, postoperative; analgesics opioid, fentanyl; anaesthesia, paediatric;
anaesthetic techniques, regional, caudal; anaesthetics local, ropivacaine
Accepted for publication: August 8, 2006

Introduction 1 mg kg 1 to the mixture of local anaesthetics (bupivacaine

Single shot caudal block is used commonly in paediatric 0.25% with epinephrine and lidocaine 1% in equal parts)
patients. The duration of surgical analgesia provided by prolonged the duration of postoperative analgesia.2 Vaso-
single shot of local anaesthetics is limited. Thus, addition constrictive property of epinephrine might contribute to pro-
of various drugs, such as clonidine,1–3 ketamine4 or long the duration of analgesia. It has been reported that
opioids,2 3 5–7 to local anaesthetics have been used to pro- ropivacaine produces vasoconstriction in contrast to vasodi-
long the pain-free period. Fentanyl is one of the common lation produced by bupivacaine.9–11 Thus, it is possible that
adjuvants with local anaesthetics8 and the effect of adding addictives to ropivacaine can provide further analgesic
fentanyl to local anaesthetics has been reported. Caudal advantages compared with bupivacaine. In this prospective,
block with bupivacaine 0.25% and fentanyl 1 mg kg 1 randomized, double-blind study, we evaluated whether the
provides no further analgesic advantages to bupivacaine addition of fentanyl 1 mg kg 1 to ropivacaine prolonged the
alone.6 7 On the other hand, addition of fentanyl duration of analgesia after a single shot caudal block.

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 The effect of caudal ropivacaine with fentanyl in children

Methods greater than 6, or if the patient complained of pain at the

After obtaining Institutional Ethics Committee approval and surgical site, i.v. pentazocine (0.3 mg kg 1) was adminis-
written informed parental consent, ASA I–II, 36 boys aged tered. If no pentazocine was necessary within 24 h, the
3–7 yr scheduled to undergo surgical procedures below the duration of analgesia was counted as 24 h. No analgesics
umbilicus were enrolled in the study. Patients were excluded other than i.v. pentazocine were given in the study period. In
if a history of allergic reactions to local anaesthetics, bleed- addition, sedation was assessed using Steward score13
ing diathesis, contraindications to caudal anaesthesia, or 30 min after extubation and at hours 1, 2, 4 and 6. Recovery
pre-existing neurological or spinal disease was present. criteria were met when a Steward score of 6 was achieved.
The study used a prospective, randomized, double-blind All measurements were recorded by the same anaesthesi-
design. ologist who did not know which medication was adminis-
Children were premedicated 30 min before surgery with tered. The incidence of side-effects (vomiting and pruritus)
midazolam 0.5 mg kg 1 orally. In the operating room, the was recorded. Finally, global assessment of the duration of
patient was prepared for arterial pressure (non-invasive), effective analgesia was performed by comparing the time
peripheral oxygen saturation (SpO2 ) and electrocardio- from caudal block to administration of the first analgesic.
graphic monitoring. Anaesthesia was induced by facemask
with sevoflurane and nitrous oxide 66% in oxygen. After Statistical analysis
placement of an i.v. cannula, the trachea was intubated Power analysis for duration of analgesia was calculated by
without the use of a neuromuscular blocking agent and referring the previous study.14 Fourteen patients in each
the lungs were ventilated mechanically. Anaesthesia was group allows a >95% chance of rejecting the null hypothesis
maintained with sevoflurane (0.6 MAC corrected for age) (Group S patients would require a rescue analgesic medica-
and nitrous oxide 66%. We measured end-tidal sevoflurane tion within 8 h and Group F patients would require a rescue
concentration using calibrated Capnomac Ultima (Datex, analgesic within 16 h, SD=5 h) at the usual level of signifi-
Finland). Caudal anaesthesia was performed in the lateral cance (a=0.05). Patients’ characteristics, duration of surgery
position with 25 gauge Axillary Block Needle (Becton and anaesthesia, time to extubation, the end-tidal concen-
Dickinson, USA) and one of the two different mixtures tration of sevoflurane at extubation and time to first anal-
described below was administered. gesics were analysed for independent samples using the
Children were allocated randomly in one of two groups by t-test. The Mann–Whitney U-test was used to compare
opening a sealed envelope. Group F received 1 ml kg 1 of means of sedation and pain score at each time point.
ropivacaine 0.2% and fentanyl 1 mg kg 1 and Group S
received 1 ml kg 1 of ropivacaine 0.2% and saline
0.02 ml kg 1. The maximum volume of ropivacaine
Results
0.2% was 30 ml; patients >30 kg were excluded so that
all subjects received an equivalent dose by weight. Caudal One subject in Group F was excluded from analysis because
solution was prepared by another anaesthesiologist who was he was very agitated at emergence and midazolam was
not involved in the study. administered i.v. in the operating room. No patient demon-
Heart rate (HR), mean arterial pressure (MAP) and SpO2 strated signs of a failed block. Data from 35 children were
were recorded before induction, after induction and then analysed. There were no differences between the groups in
5 min after caudal anaesthesia. During surgery, adequate terms of age, height, weight, duration of surgery or duration
analgesia was defined by haemodynamic stability, as indi- of anaesthesia (Table 1). There were no differences between
cated by the absence of an increase in MAP or HR of more the groups in haemodynamic and respiratory parameters
than 15% compared with baseline values obtained just (data not shown). The end-tidal concentration
before the surgical incision. If HR or MAP increased by of sevoflurane at extubation in Group F [mean (SD), 0.33
more than 15%, analgesia was considered inadequate and (0.079)%] was significantly lower than in Group S [0.38
subsequent data obtained from those children were no
Table 1 Patient demographics and clinical data. Data are presented as mean
longer considered. During surgery, children received acetate
(range) or (SD). There were no differences between the groups
Ringer’s solution 5 ml kg 1 h 1. Time from discontinuing
the volatile anaesthetic to tracheal extubation and end-tidal Group F (n=17) Group S (n=18)
sevoflurane concentration at extubation were recorded. Age (months) 48.1 (36–83) 51.6 (36–85)
MAP, HR and SpO2 values were recorded 30 min after Height (cm) 100 (8.6) 101 (8.7)
extubation and at 1, 2, 4, 6, 12 and 24 h. The analgesic effect Weight (kg) 15.4 (2.3) 16.5 (2.9)
Duration of surgery (min) 124 (44) 133 (56)
of caudal block was evaluated using the Children’s Hospital Duration of anaesthesia (min) 172 (48) 184 (58)
of Eastern Ontario Pain Scale (CHEOPS12) 30 min after Type of surgery
extubation and at 1, 2, 4, 6, 12 and 24 h. When the CHEOPS Hypospadias repair 12 14
Orchiopexy 3 2
score was greater than 6, analgesic was given in previous Correction of vesicoureteral reflux 2 2
studies.2 3 In the present study, if the patient’s CHEOPS was

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 Kawaraguchi et al.

Table 2 CHEOPS. CHEOPS are expressed as median (range in parentheses) A previous report18 demonstrated that ropivacaine 0.2%
Group F (n=17) Group S (n=18)
provided satisfactory postoperative pain relief and 0.1%
was less efficacious, whereas 0.3% was associated with a
At 30 min 6 (6–10) 6 (6–12) more frequent incidence of motor block with minimal
At 1h 6 (6–6) 6 (5–8)
At 2h 6 (5–7) 6 (5–10)
improvement in postoperative pain relief. Thus, we chose
At 4h 6 (5–7) 6 (4–12) ropivacaine 0.2% in the present study. In addition, it has
At 6h 6 (5–8) 6 (4–10) been reported that ropivacaine produces vasoconstriction in
At 12 h 6 (5–7) 6 (4–6)
At 24 h 6 (5–7) 6 (4–6)
contrast to vasodilation produced by bupivacaine.9–11 Thus,
we hypothesized that addictives to ropivacaine can provide
further analgesic advantages compared with bupivacaine.
Table 3 Steward scores. Steward scores are expressed as median (range in To our knowledge, the present study is the first report
parentheses) regarding the effects of adding fentanyl to ropivacaine on
Group F (n=17) Group S (n=18) single caudal block in children. Consequently, this study
revealed that the same analgesic intensity of the caudal
At 30 min 5 (2–6) 6 (2–6)
At 1h 6 (2–6) 6 (2–6)
block whether using the mixture of fentanyl 1 mg kg 1
At 2h 6 (3–6) 6 (4–6) and ropivacaine or ropivacaine alone.
At 4h 6 (2–6) 6 (2–6) In the study, the end-tidal concentration of sevoflurane at
At 6h 6 (3–6) 6 (3–6)
extubation in Group F was significantly lower than in Group
S. In a previous report, Katoh and colleagues19 demon-
strated the MACawake reduction of sevoflurane by constant
(0.064)%] (P<0.05). However, there was no significant plasma fentanyl concentrations. Our results are in close
difference in time from discontinuation of the sevoflurane agreement with the report. However, we do not think that
to tracheal extubation [mean (SD), 7.2 (1.7) min in Group F the difference is clinically significant because there was no
and 6.6 (1.3) min in Group S]. A total of 11 patients in Group significant difference in time from discontinuation of the
F and 12 patients in Group S received rescue analgesia. A sevoflurane to tracheal extubation. Furthermore, the addi-
trend towards more time to first analgesic rescue was tion of fentanyl to ropivacaine had a trend towards extending
observed in Group F [mean (SD), 836 (502) min] compared time to first analgesic rescue; however, we do not think that
with Group S [734 (544) min]; however, it was not this small difference is significant from a clinical view point.
statistically significant. In addition, no statistical differences A possible explanation for our inability to demonstrate a
were found in CHEOPS (Table 2) and Steward score significant benefit with the addition of fentanyl is that the
(Table 3). The incidence of postoperative vomiting (four dose of fentanyl (1 mg kg 1) was too small to exhibit anal-
patients in Group F and six patients in Group S) and pruritus gesic advantage on the postoperative pain scores, although
(one patient in both Groups F and S) was not significantly this dose is the common and accepted dose in the previous
different. reports. However, there is a need for further study on the
safety profiles and dose–response characteristics of fentanyl
added to ropivacaine for caudal block.
Discussion The limitation of the study is the difficulty in differenti-
The present study found that adding fentanyl 1 mg kg 1 to ating between pain response and agitation on emergence,
ropivacaine 0.2% for a single shot caudal analgesia did not especially in younger children. Among the patients
alter the mean time to first analgesic and postoperative pain administered analgesics, there might be the one exhibiting
scores (CHEOPS) were similar in both groups. agitations rather than pain complaint. Furthermore, type of
Fentanyl is one of the most commonly used adjuvants surgical procedure is varied in the study. The intensity of
with local anaesthetics in caudal blocks.8 However, only a postoperative pain may vary depending on the type of sur-
few studies have addressed the benefit of fentanyl-local gical procedure.
anaesthetic mixture. Constant and colleagues2 demonstrated In conclusion, the addition of fentanyl 1 mg kg 1 to ropi-
that the addition of fentanyl to bupivacaine and lidocaine vacaine 0.2% for caudal analgesia provides no further anal-
with epinephrine prolonged the duration of surgical analge- gesic advantages to ropivacaine 0.2% alone in children
sia for caudal block undergoing bilateral vesicoureteral undergoing surgical procedures below the umbilicus.
reflux. In contrast, other studies have reported that there is
no beneficial effect to the mixture of fentanyl 1 mg kg 1 and
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