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.

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 Overview

• Status: Completed
• Conditions: Anesthetic, Sedative or Analgesic Complications in Labor or Delivery
• Intervention / Treatment: Drug: Fentanyl

• Study Type: Interventional
• Enrollment (Actual): 105
• Phase: Phase 3

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • London, Ontario, Canada, N6A5W9
      • Victoria Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: 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 Names: 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 Names: Duragesic, Actiq

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The time, in minutes, since completion of epidural bolus to the first painless contraction	A painless contraction = verbal Numeric Pain Rating Scale less than or equal to 3/10	Time since epidural bolus dose administration (At 1 and 5 minutes )

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sensory block height to ice		30 minutes after epidural bolus dose
Pruritis	Pruritus will be measured using a 4-point scale, where 0 is none, 1 is mild, 2 is moderate, and 3 is severe.	30 minutes after epidural bolus dose
Nausea	Nausea will be measured using a 4-point scale, where 0 is none, 1 is mild, 2 is moderate, and 3 is severe.	30 minutes after epidural bolus dose
Maternal sedation	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.	30 minutes after epidural bolus dose
Hypotension	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.	30 minutes after epidural bolus dose
Motor block	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).	30 minutes after epidural bolus dose
Time, in minutes, from epidural bolus dose to use of patient controlled epidural demand dose	time after epidural loading dose at which patient uses Patient Controlled Epidural Analgesia administered bolus	Estimated time frame 1 hour
Patient satisfaction of analgesia	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.	30 minutes from epidural bolus dose
Incidence of failed analgesia	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.	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	Has breastfeeding been established at 24 hours post-delivery?	24 hours after delivery

Collaborators and Investigators

• Sponsor: Lawson Health Research Institute
• Collaborators: University of Western Ontario, Canada
• Investigators: Principal Investigator: Indu Singh, Schulich School of Medicine and Dentistry/Anaesthesia

Study record dates

Study Major Dates

• Study Start: December 1, 2013
• Primary Completion (Actual): October 1, 2014
• Study Completion (Actual): May 1, 2015

Study Registration Dates

• First Submitted: November 26, 2013
• First Submitted That Met QC Criteria: December 6, 2013
• First Posted (Estimate): December 9, 2013

Study Record Updates

• Last Update Posted (Estimate): May 12, 2016
• Last Update Submitted That Met QC Criteria: May 10, 2016
• Last Verified: May 1, 2016

More Information

Terms related to this study

• Keywords: Fentanyl; Bupivacaine; Labor epidural analgesia; Onset
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Opioid; Narcotics; Adjuvants, Anesthesia; Fentanyl
• Other Study ID Numbers: 104456

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: IPD will not be available