Parker et al.: EPIDURAL HYDROMORPHONE AND LABOUR
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cost and the fact there was a lack of significant anal-
gesic difference compared to sufentanil.3
100 µg with normal saline to a total volume of 10 mL;
group HYD: fentanyl 100 µg and hydromorphone
300 µg with normal saline to a total volume of 10 mL.
Patients were placed in the recumbent position
with left uterine displacement. VAS scores and the
severity of side effects were recorded ten, 20, and 30
min after the administration of the study infusion and
every 30 min thereafter. Observations were performed
by an individual blinded to the analgesic technique. At
the time of each assessment, vital signs, modified
Bromage motor scale scores,7 pruritus, nausea, vomit-
ing and sedation were evaluated. Motor block was
defined as none, partial (just able to move the knees),
almost complete (able to move the feet only), or com-
plete (unable to move the lower extremities). Pruritus
was rated as none, minimal (present with minimal
symptoms), moderate (bothersome but not requiring
therapy), or severe (requiring therapy). Sedation was
categorized as none (awake), mild (drowsy), moderate
(sleepy) or severe (unarousable). The fetal heart rate
pattern was evaluated at each interval and any changes
were documented. After the first 30 min, patients
were allowed to ambulate with assistance provided
there was no detectable motor block and the fetal
heart rate pattern was reassuring. Oxygen saturation
was monitored while patients were at bedrest. The
time at which each patient requested additional anal-
gesia was recorded, vital signs were documented, pain
and side effect assessments were performed, and the
study period was concluded. The epidural anesthetics
were subsequently managed by the anesthesia team, as
appropriate, for the remainder of labour. The length
of labour, incidence of Cesarean delivery, incidence of
postdural puncture headache (PDPH), and neonatal
Apgar scores were recorded.
A plan for treating inadequate analgesia was standard-
ized. If a patient did not experience adequate analgesia
20 min after the initial study dose, 15 mL of 0.125%
bupivacaine would be administered via the epidural
catheter. If this did not provide relief after an additional
20 min, 10 mL of 2% lidocaine would be administered.
If this did not result in an adequate level of analgesia,
then the epidural catheter would be replaced.
Before this study was instituted, a power analysis
was performed assuming: a duration of fentanyl anal-
gesia of 124 42 min,1,3 a hydromorphone analgesia
duration of 165 45 min; 90% power, and an alpha of
0.05. This yielded a required sample size of 21
patients per group.
In a pilot study, hydromorphone 300 µg following
a lidocaine-epinephrine test dose demonstrated an
analgesic onset time of greater than 20 min, which was
determined to be too long to be clinically useful. We
postulated that combining a “quick-onset” short-act-
ing opioid (i.e., fentanyl) with a longer-onset, longer-
acting opioid (i.e., hydromorphone) would achieve
the benefits of both medications: a quick-onset, long
duration “ambulatory” epidural. We thus undertook
this study to determine the influence of hydromor-
phone on the duration of analgesia when administered
along with fentanyl after a lidocaine and epinephrine
test dose, in primigravid patients during the early first
stage of labour.
Methods
Before this study was initiated, Institutional Review
Board approval was obtained. Forty-four primigravid
ASA physical status I or II obstetric patients, at greater
than 36 weeks of gestation, who had requested labour
analgesia, gave written informed consent. Patients were
excluded if cervical dilation was greater than 5 cm, if
they had received iv opioid agonists or agonist/antago-
nists, had pre-eclampsia, or had a contraindication to
fentanyl or hydromorphone. A normal fetal heart rate
pattern (absence of decelerations) was required for
inclusion in the study. Patients were randomized to
group C (control) or group HYD (hydromorphone)
using a random series of 44 numbers generated with
Microsoft Excel’s Randbetween function.
Before the procedure began, the patients’ vital
signs (blood pressure, heart rate, and respiratory rate)
were documented, and the patients were asked to
relate any symptoms of pruritus, nausea, or vomiting.
Each patient also completed a baseline assessment
using a 100-mm visual analogue scale (VAS) for pain,
with 0 representing no pain and 100 being the worst
possible pain. Each patient received a minimum of
500 mL of Ringer’s lactate solution intravenously. All
procedures were performed with patients in the sitting
position. A lumbar epidural catheter was inserted
approximately 5 cm into the epidural space by using a
Tuohy-Schiff needle (B-Braun Medical, Bethlehem,
PA, USA). The patients then received a test dose of 3
mL of 1.5% lidocaine with 1:200,000 epinephrine. If
the test dose was negative for intravascular injection
(heart rate within 15 beats·min–1 of baseline values in
two minutes of monitoring) and intrathecal injection
(no spinal block after three minutes of monitoring),
the patient was given one of two epidural injections in
a double-blinded fashion as follows: group C: fentanyl
Demographic data were analyzed by using analysis
of variance. Pain scores were analyzed by using the
Mann- Whitney U test. Presence or absence of side
effects was analyzed by contingency testing. A Kaplan-