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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02004899
First Posted: December 9, 2013
Last Update Posted: May 12, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
University of Western Ontario, Canada
Information provided by (Responsible Party):
Indu Singh, Lawson Health Research Institute
  Purpose

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.


Condition Intervention Phase
Anesthetic, Sedative or Analgesic Complications in Labor or Delivery Drug: Fentanyl Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Onset of Labor Epidural Analgesia With Low Dose Bupivacaine and Different Doses of Fentanyl: a Randomized Double Blinded Clinical Trial.

Resource links provided by NLM:


Further study details as provided by Indu Singh, Lawson Health Research Institute:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • Sensory block height to ice [ Time Frame: 30 minutes after epidural bolus dose ]
  • 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.

  • 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.

  • 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.

  • 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.

  • 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).

  • 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

  • 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.

  • 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.

  • 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 [ Time Frame: 24 hours after delivery ]
    Has breastfeeding been established at 24 hours post-delivery?


Enrollment: 105
Study Start Date: December 2013
Study Completion Date: May 2015
Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: F20
Patients randomized to this arm of the study receive 20 mcg fentanyl and 8 mg bupivacaine as their epidural loading dose
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 Name: Duragesic, Actiq
Experimental: F50
Patients randomized to this arm of the study receive 50 mcg fentanyl with 8 mg bupivacaine as their epidural loading dose
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 Name: Duragesic, Actiq
Experimental: F100
Patients randomized to this arm of the study receive 100 mcg fentanyl and 8 mg bupivacaine as their epidural loading dose
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 Name: Duragesic, Actiq

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02004899


Locations
Canada, Ontario
Victoria Hospital
London, Ontario, Canada, N6A5W9
Sponsors and Collaborators
Lawson Health Research Institute
University of Western Ontario, Canada
Investigators
Principal Investigator: Indu Singh Schulich School of Medicine and Dentistry/Anaesthesia
  More Information

Responsible Party: Indu Singh, Associate Professor, Lawson Health Research Institute
ClinicalTrials.gov Identifier: NCT02004899     History of Changes
Other Study ID Numbers: 104456
First Submitted: November 26, 2013
First Posted: December 9, 2013
Last Update Posted: May 12, 2016
Last Verified: May 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: IPD will not be available

Keywords provided by Indu Singh, Lawson Health Research Institute:
Labor epidural analgesia
Fentanyl
Bupivacaine
Onset

Additional relevant MeSH terms:
Bupivacaine
Fentanyl
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Analgesics, Opioid
Narcotics
Analgesics
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General