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NCT Number: NCT02004899

Trial of Onset of Epidural Pain Relief With Low Dose Bupivacaine and Different Doses of Fentanyl in Laboring Women

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.

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Key information

Conditions

Anesthetic, Sedative or Analgesic Complications in Labor or Delivery

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Victoria Hospital

London, Ontario, N6A5W9, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fentanyl

Drug

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

Primary outcomes

  1. The time, in minutes, since completion of epidural bolus to the first painless contraction

    Time frame: 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 outcomes

  1. Sensory block height to ice

    Time frame: 30 minutes after epidural bolus dose

  2. Pruritis

    Time frame: 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.

  3. Nausea

    Time frame: 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.

  4. Maternal sedation

    Time frame: 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.

  5. Hypotension

    Time frame: 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.

  6. Motor block

    Time frame: 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).

  7. Time, in minutes, from epidural bolus dose to use of patient controlled epidural demand dose

    Time frame: Estimated time frame 1 hour

    time after epidural loading dose at which patient uses Patient Controlled Epidural Analgesia administered bolus

  8. Patient satisfaction of analgesia

    Time frame: 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.

  9. Incidence of failed analgesia

    Time frame: 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.

  10. Incidence of fetal bradycardia

    Time frame: Estimated time frame 24 hours

  11. Time, in minutes, from completion of epidural test dose to delivery

    Time frame: Estimated time frame 24 hours

  12. Type of delivery

    Time frame: Estimated time frame 24 hours

  13. Fetal birth weight

    Time frame: Estimated time frame 24 hours

  14. Neonatal Apgar scores

    Time frame: At 1 and 5 minutes post-delivery

  15. Breastfeeding

    Time frame: 24 hours after delivery

    Has breastfeeding been established at 24 hours post-delivery?

Sponsors and collaborators

Lead sponsor

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Other

Collaborators

  • University of Western Ontario, Canada

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2014
Study completion
2015
First posted
Dec 9, 2013
Registry last updated
May 12, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.