Trial | NCT02004899  Report issue

Title

Trial of Onset of Epidural Pain Relief With Low Dose Bupivacaine and Different Doses of Fentanyl in Laboring Women
Onset of Labor Epidural Analgesia With Low Dose Bupivacaine and Different Doses of Fentanyl: a Randomized Double Blinded Clinical Trial.

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    fentanyl ...

  • Study Participants

    105
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 Started
Dec 31
2013
Primary Completion
Oct 31
2014
Study Completion
May 31
2015
Last Update
May 12
2016
Estimate

Drug Fentanyl

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).

  • Other names: Duragesic, Actiq

F20 Active Comparator

Patients randomized to this arm of the study receive 20 mcg fentanyl and 8 mg bupivacaine as their epidural loading dose

F50 Experimental

Patients randomized to this arm of the study receive 50 mcg fentanyl with 8 mg bupivacaine as their epidural loading dose

F100 Experimental

Patients randomized to this arm of the study receive 100 mcg fentanyl and 8 mg bupivacaine as their epidural loading dose

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
No Results Posted