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

NCT02004899 | Completed Phase 3

• 1 other identifier: 104456
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

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.

Conditions

Anesthetic, Sedative or Analgesic Complications in Labor or Delivery

Keywords

Labor epidural analgesia; Fentanyl; Bupivacaine; Onset

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (15)

• Sensory block height to ice

  30 minutes after epidural bolus dose

• Pruritis

  30 minutes after epidural bolus dose

• Nausea

  30 minutes after epidural bolus dose

• Maternal sedation

  30 minutes after epidural bolus dose

• Hypotension

  30 minutes after epidural bolus dose

Study Arms (3)

F20

ACTIVE COMPARATOR

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

Drug: Fentanyl

F50

EXPERIMENTAL

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

Drug: Fentanyl

F100

EXPERIMENTAL

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

Drug: Fentanyl

Interventions

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).

Also known as: Duragesic, Actiq

F100; F20; F50

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: lead
• University of Western Ontario, Canada: collaborator

Study Sites (1)

Victoria Hospital

London, Ontario, N6A5W9, Canada

Location

MeSH Terms

Interventions

Fentanyl

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Indu Singh

  Schulich School of Medicine and Dentistry/Anaesthesia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: November 26, 2013
• First Posted: December 9, 2013
• Study Start: December 1, 2013
• Primary Completion: October 1, 2014
• Study Completion: May 1, 2015
• Last Updated: May 12, 2016

Record last verified: 2016-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)