Anesthetic, Sedative or Analgesic Complications in Labor or Delivery
Conditions
Keywords
Labor epidural analgesia, Fentanyl, Bupivacaine, Onset
Brief summary
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.
Interventions
DRUGFentanyl
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).
Sponsors
University of Western Ontario, Canada
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* American Society of Anesthesiologists (ASA) physical status 1 or 2 * Pregnant women in early labor (cervical dilation \<5cm) * Singleton fetuses * Gestational age more than 36 weeks * Normal fetal heart rate tracing
Exclusion criteria
* Severe pre-ecclampsia * Antepartum hemorrhage * ASA \>3 * Chronic pain * Substance abuse * Language barrier between patient and investigator * Contraindications to epidural analgesia * Allergies to local anesthetics or fentanyl * Morbid obesity * Previous administration of opioid analgesia
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The time, in minutes, since completion of epidural bolus to the first painless contraction | Time since epidural bolus dose administration (At 1 and 5 minutes ) | A painless contraction = verbal Numeric Pain Rating Scale less than or equal to 3/10 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pruritis | 30 minutes after epidural bolus dose | Pruritus will be measured using a 4-point scale, where 0 is none, 1 is mild, 2 is moderate, and 3 is severe. |
| Nausea | 30 minutes after epidural bolus dose | Nausea will be measured using a 4-point scale, where 0 is none, 1 is mild, 2 is moderate, and 3 is severe. |
| Maternal sedation | 30 minutes after epidural bolus dose | 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. |
| Hypotension | 30 minutes after epidural bolus dose | 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. |
| Motor block | 30 minutes after epidural bolus dose | 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, in minutes, from epidural bolus dose to use of patient controlled epidural demand dose | Estimated time frame 1 hour | time after epidural loading dose at which patient uses Patient Controlled Epidural Analgesia administered bolus |
| Patient satisfaction of analgesia | 30 minutes from epidural bolus dose | 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. |
| Sensory block height to ice | 30 minutes after epidural bolus dose | — |
| Incidence of fetal bradycardia | Estimated time frame 24 hours | — |
| Time, in minutes, from completion of epidural test dose to delivery | Estimated time frame 24 hours | — |
| Type of delivery | Estimated time frame 24 hours | — |
| Fetal birth weight | Estimated time frame 24 hours | — |
| Neonatal Apgar scores | At 1 and 5 minutes post-delivery | — |
| Breastfeeding | 24 hours after delivery | Has breastfeeding been established at 24 hours post-delivery? |
| Incidence of failed analgesia | 30 minutes after epidural bolus dose | 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. |
Countries
Canada
Outcome results
None listed