Clinical trial NCT02004899: Trial of Onset of Epidural Pain Relief With Low Dose Bupivacaine and Different Doses of Fentanyl in Laboring Women
Official title: Onset of Labor Epidural Analgesia With Low Dose Bupivacaine and Different Doses of Fentanyl: a Randomized Double Blinded Clinical Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Anesthetic, Sedative or Analgesic Complications in Labor or Delivery
Keywords: Labor epidural analgesia
Fentanyl
Bupivacaine
Onset
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor class: OTHER
Collaborators: name: University of Western Ontario, Canada
First posted: 2013-12-09
Enrollment: 105
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: The time, in minutes, since completion of epidural bolus to the first painless contraction
timeFrame: Time since epidural bolus dose administration (At 1 and 5 minutes )
Secondary outcomes:
measure: Sensory block height to ice
timeFrame: 30 minutes after epidural bolus dose
measure: Pruritis
timeFrame: 30 minutes after epidural bolus dose
measure: Nausea
timeFrame: 30 minutes after epidural bolus dose
measure: Maternal sedation
timeFrame: 30 minutes after epidural bolus dose
measure: Hypotension
timeFrame: 30 minutes after epidural bolus dose
measure: Motor block
timeFrame: 30 minutes after epidural bolus dose
measure: Time, in minutes, from epidural bolus dose to use of patient controlled epidural demand dose
timeFrame: Estimated time frame 1 hour
measure: Patient satisfaction of analgesia
timeFrame: 30 minutes from epidural bolus dose
measure: Incidence of failed analgesia
timeFrame: 30 minutes after epidural bolus dose
measure: Incidence of fetal bradycardia
timeFrame: Estimated time frame 24 hours
measure: Time, in minutes, from completion of epidural test dose to delivery
timeFrame: Estimated time frame 24 hours
measure: Type of delivery
timeFrame: Estimated time frame 24 hours
measure: Fetal birth weight
timeFrame: Estimated time frame 24 hours
measure: Neonatal Apgar scores
timeFrame: At 1 and 5 minutes post-delivery
measure: Breastfeeding
timeFrame: 24 hours after delivery
Other outcomes:
Locations:
city: London
country: Canada
facility: Victoria Hospital
state: Ontario
Study officials:
affiliation: Schulich School of Medicine and Dentistry/Anaesthesia
name: Indu Singh
role: PRINCIPAL_INVESTIGATOR
References: