Epidural analgesia is the most effective form of labor pain relief. Low doses of local anesthetic (freezing solutions) in combination with opioids (narcotics) are commonly used as epidural solutions to provide pain relief. Low dose local anesthetic solutions with opioids for labor have been shown to decrease motor block (leg weakness or temporary paralysis), without affecting labor pain relief. However, onset of pain relief can be delayed with these low dose solutions. The standard epidural solution used at Victoria Hospital is a low dose of local anesthetic called bupivacaine mixed with fentanyl, an opioid, for labor epidural pain relief. There is some evidence that the addition of more fentanyl to the epidural bolus dose of bupivacaine at the start of labor epidural analgesia can speed onset of pain relief. Both medications are safe for you and your baby. This study will investigate whether the addition of different doses of fentanyl (20 mcg, 50 mcg and 100 mcg) to the epidural bolus dose speeds onset of pain relief. The study hypothesis is that the onset of epidural labor analgesia will be shortest with the larger fentanyl epidural bolus.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
105
After obtaining informed consent, patients are randomized into one of two treatment groups or a control group by a computer generated random number table. After confirmation of epidural placement following test dose administration, a loading dose of 10 ml 0.08% Bupivacaine containing 20 mcg Fentanyl is administered after adding 1.6 ml 0.9% NaCl (Sodium Chloride) in the control group (F20).
Victoria Hospital
London, Ontario, Canada
The time, in minutes, since completion of epidural bolus to the first painless contraction
A painless contraction = verbal Numeric Pain Rating Scale less than or equal to 3/10
Time frame: Time since epidural bolus dose administration (At 1 and 5 minutes )
Sensory block height to ice
Time frame: 30 minutes after epidural bolus dose
Pruritis
Pruritus will be measured using a 4-point scale, where 0 is none, 1 is mild, 2 is moderate, and 3 is severe.
Time frame: 30 minutes after epidural bolus dose
Nausea
Nausea will be measured using a 4-point scale, where 0 is none, 1 is mild, 2 is moderate, and 3 is severe.
Time frame: 30 minutes after epidural bolus dose
Maternal sedation
Maternal sedation will be measured using a 5-point scale where 0 is wide awake, 1 is mildly drowsy, 2 is very drowsy, 3 is asleep but rousable, and 4 is somnolent.
Time frame: 30 minutes after epidural bolus dose
Hypotension
Hypotension is defined as a decrease in systolic blood pressure by 30% or more, or less than 90 mmHg. It is treated with intravenous ephedrine.
Time frame: 30 minutes after epidural bolus dose
Motor block
Motor block will be assessed using a modified Bromage score (0 = ability to move hips, ankles, and knees, 1 = inability to raise extended leg, 2 = inability to flex knee, and 3 = inability to flex ankle, foot or knee).
Time frame: 30 minutes after epidural bolus dose
Time, in minutes, from epidural bolus dose to use of patient controlled epidural demand dose
time after epidural loading dose at which patient uses Patient Controlled Epidural Analgesia administered bolus
Time frame: Estimated time frame 1 hour
Patient satisfaction of analgesia
Patient satisfaction of analgesia will be measured using a 5-point scale where 0 is completely dissatisfied, 1 is somewhat dissatisfied, 2 is neutral, 3 is somewhat satisfied, and 4 is completely satisfied.
Time frame: 30 minutes from epidural bolus dose
Incidence of failed analgesia
Patients who have a verbal Numeric Rating Scale score greater than 3/10 after 30 minutes of epidural bolus dose will be deemed a failure.
Time frame: 30 minutes after epidural bolus dose
Incidence of fetal bradycardia
Time frame: Estimated time frame 24 hours
Time, in minutes, from completion of epidural test dose to delivery
Time frame: Estimated time frame 24 hours
Type of delivery
Time frame: Estimated time frame 24 hours
Fetal birth weight
Time frame: Estimated time frame 24 hours
Neonatal Apgar scores
Time frame: At 1 and 5 minutes post-delivery
Breastfeeding
Has breastfeeding been established at 24 hours post-delivery?
Time frame: 24 hours after delivery
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