MedTrace Logo

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

NCT02004899 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 105

Last updated 2016-05-12

No results posted yet for this study

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

Interventions

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).

Sponsors & Collaborators

  • University of Western Ontario, Canada

    collaborator OTHER

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

    lead OTHER

Principal Investigators

  • Indu Singh · Schulich School of Medicine and Dentistry/Anaesthesia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-12-31
Primary Completion
2014-10-31
Completion
2015-05-31

Countries

  • Canada

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02004899 on ClinicalTrials.gov