Beruflich Dokumente
Kultur Dokumente
doi:10.1111/anae.12093
Original Article
A randomised comparison of variable-frequency
automated mandatory boluses with a basal infusion for
patient-controlled epidural analgesia during labour and
delivery
A. T. Sia,1 S. Leo2 and C. E. Ocampo3
1 Chairman Medical Board and Senior Consultant, 2 Consultant, 3 Senior Resident Physician, Department of Womens
Anaesthesia, KK Womens and Childrens Hospital, Singapore
Summary
This trialwas conductedtocompare the analgesic effcacyof administeringvariable-frequencyautomatedboluses ata rate
proportional to the patients needs with fxed continuous basal infusion in patient-controlled epidural analgesia (PCEA)
during labour and delivery. We recruited a total of 102 parturients in labour who were randomly assigned to receive
either anovelPCEAwithautomatedmandatorybolusesof5 mladministeredonce,twice,threeorfourtimesperhourdepending
on the history of the parturients analgesic demands over the past hour (Automated bolus group), or a conventional
PCEA with a basal infusion of 5 ml.h 1 (Infusion group). The incidence of breakthrough pain requiring supplementation
by an anaesthetist was signifcantly lower in the Automated bolus group, three out of 51 (5.9%) compared with the
Infusion group, 12 out of 51 (23.5%, p = 0.023). The time-weighted mean (SD) hourly consumption of ropivacaine was
similar in both groups, 10.0 (3.0) mg in the Automated bolus group vs 11.1 (3.2) mg in the Infusion group (p = 0.06).
Parturients from the Automated bolus group reported higher satisfaction scores compared with those in the Infusion
group, 96.5 (5.0) vs 89.2 (9.4), respectively (p < 0.001). There was no difference in the incidence of maternal sideeffects and obstetric and neonataloutcomes.
.................................................................................................................................................................
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Sia et al. | Comparison of variable-frequency mandatory boluses with basal infusion for PCEA Anaesthesia
2013, 68, 267275
Methods
This study was conducted with the approval of the
Hospital Ethics Committee and written informed
consent was obtained from every parturient who
participated in the study. We recruited 102 healthy (ASA
physical status 1) nulliparous parturients at term (> 36
weeks, gestation) with a singleton fetus, who were in
early labour (cervical dilation < 5 cm) and who had
requested labour epidural analgesia.
Parturients with multiple pregnancies, non-cephalic
fetal presentation and obstetric complications (e.g. preeclampsia and premature rupture of amniotic
membranes) were not studied. Parturients who had
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Sia et al. | Comparison of variable-frequency mandatory boluses with basal infusion for PCEA Anaesthesia
2013, 68, 267275
269
Anaesthesia 2013, 68, 267275 Sia et al. | Comparison of variable-frequency mandatory boluses with
basal infusion for PCEA
Sia et al. | Comparison of variable-frequency mandatory boluses with basal infusion for PCEA Anaesthesia
2013, 68, 267275
Results
All 102 recruited parturients completed the study (Fig.
3). Baseline demographic and pre-block obstetric data
were similar for parturients in both groups (Table 1).
None of the patients had a failed spinal or an ineffective
epidural catheter. No parturients had intravascular
misplacement of the epidural catheter or accidental
dural puncture.
The incidence of the primary study outcome,
breakthrough pain requiring epidural top-up by an
attending anaesthetist, was signifcantly lower in the
Automated bolus group with three patients (5.9%)
compared with the Infusion group with 12 patients
(23.5%, p = 0.023). There were two patients in the
Infusion group who experienced two episodes of
breakthrough pain, of whom one delivered vaginally
and the other underwent caesarean delivery for poor
progress of labour. The patient profles at the time of
breakthrough pain are shown in Table 2.
The improved analgesic effcacy in the Automated
bolus group was achieved without any signifcant
difference in the amount of local anaesthetic consumed.
The time-weighted mean hourly consumption of
ropivacaine, inclusive of clinician-administered
supplemental boluses, was similar in both groups, 10.0
(3.0) mg in the Automated bolus group vs 11.1 (3.2) mg
in the Infusion group (p = 0.06). There was no
difference in the total amount of ropivacaine used, 62.0
(32.6) mg in the Automated bolus group vs 74.2 (34.0)
mg in the Infusion group (p = 0.07). The time to frst
patientdemand bolus following CSE was similar, 115.8
(65.2) min in the Automated bolus group vs 112.1 (70.4)
min in the Infusion group (p = 0.78).
Mixed model repeated measurement analysis did
not detect any difference in post-block serial pain scores
(p = 0.146 for the interactive term of group and VAS
score) or sensory levels (p = 0.619 for the interactive
271
Anaesthesia 2013, 68, 267275 Sia et al. | Comparison of variable-frequency mandatory boluses with
basal infusion for PCEA
27.3 (3.9)
3.2 (0.7)
113.8 (10.6)
67.8 (9.5)
76.0 (10.1)
139.4 (10.1)
8.0 (1.7)
28 (55.0%)
4 (7.8%)
18 (35.3%)
23 (45.1%)
33 (64.7%)
Infusion
(n = 51)
28.2 (4.9)
3.2 (0.9)
115.9 (11.9)
68.4 (9.3)
79.2 (13.2)
141.2 (11.1)
7.8 (1.5)
24 (47.1%)
6 (11.8%)
14 (27.5%)
20 (39.2%)
28 (54.9%)
Sia et al. | Comparison of variable-frequency mandatory boluses with basal infusion for PCEA Anaesthesia
2013, 68, 267275
Table 2 Analgesic and obstetric profle of parturients assigned to PCEA with an automated bolus or basal infusion, at
the time that breakthrough pain was experienced. Values are median (IQR [range]).
Automated
bolus (n = 3)
Time to 1st breakthrough pain; min
Infusion
(n = 12)
25 (1565 [1565])
6 (37 [37])
6 (66 [66])
18 (1242 [1242])
T8 (T6T10 [T6T10])
0 [00]
p
value*
286.5 (164391 [145630]) 0.99
47.5 (3465 [20100])
6.5 (58 [310])
7.5 (69 [510])
12 (027 [072])
T8 (T7T10 [T6T10])
0 [00]
0.25
0.42
0.12
0.30
0.89
1.0
*Non-parametric tests were applied owing to the small number of patients with breakthrough pain.
Discussion
p
value
0.69
Automated
bolus (n = 51)
Duration of labour; min
Duration of 2nd stage; min
Rate of machine-delivered
epidural medication during
2nd stage of labour; ml.h1
Mode of delivery
Normal
Instrumental
389.4 (202.9)
414.2 (181.3)
69.8 (48.9)
10.9 (4.5)
84.9 (57.9)
4.8 (1.0)
33 (64.7%)
5 (9.8%)
Caesarean
13 (25.5%)
Anaesthesia
2012 The Association of Anaesthetists of Great
Britain and Ireland
Neonatal birthweight; g
Neonatal Apgar score at 5 min
Satisfaction score
Infusion
(n = 51)
3244.4 (392.5)
9 (99 [79])
96.5 (5.0)
p value
0.52
0.22
<
0.001
32 (62.7%)
8 (15.7%)
0.65
11 (21.6%)
273
0.08
1.00
<
0.001
3083.5 (502.9)
9 (99 [99])
89.2 (9.4)
Anaesthesia 2013, 68, 267275 Sia et al. | Comparison of variable-frequency mandatory boluses with
basal infusion for PCEA
Sia et al. | Comparison of variable-frequency mandatory boluses with basal infusion for PCEA Anaesthesia
2013, 68, 267275
Acknowledgements
8.
9.
Competing interests
No
external funding and
interests declared.
no
competing
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