Intravenous Remifentanil Patient-controlled Analgesia (PCA) and Epidural Patient Controlled Epidural Analgesia (PCEA) for Labor Analgesia

This study has been completed.
Information provided by:
Hadassah Medical Organization Identifier:
First received: December 2, 2008
Last updated: April 19, 2015
Last verified: February 2010

Women requesting analgesia do not always wish to receive a potent analgesic method, and may fear the risks of epidural analgesia.

Study Aim: To determine whether remifentanil is effective for labor analgesia when compared with standard treatment (epidural analgesia).

Condition Intervention Phase
Drug: Bupivacaine epidural
Drug: Remifentanil
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Comparison of the Efficacy Intravenous Remifentanil PCA and Epidural PCEA for Labor Analgesia

Resource links provided by NLM:

Further study details as provided by Hadassah Medical Organization:

Primary Outcome Measures:
  • Primary analgesia end-point: VAS pain Score [ Time Frame: 1-6 hours ] [ Designated as safety issue: No ]

Enrollment: 50
Study Start Date: February 2010
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Epidural group
Drug: Bupivacaine epidural
Bupivacaine 0.1%, fentanyl 1 mic/kg
Active Comparator: 2
Remifentanil iv PCA
Drug: Remifentanil
40-50 mic per 1-2 min via PCA


Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion criteria:

  • Healthy women
  • American Society of Anesthesiologists physical status class I or II
  • Body weight less than 110 kg
  • In active labor (including induced labor and premature rupture of membranes)
  • Cervical dilatation at 2-6 cm
  • Regular contractions
  • Age between 18 and 40 years old
  • Gestational age greater than 36 completed weeks
  • Singleton pregnancy and vertex presentation

Exclusion criteria:

  • Contraindication for epidural analgesia (bleeding diathesis, neuropathy, severe scoliosis, previous spine surgery, local anesthetic allergy)
  • Narcotic administration in the previous 2 hours
  • Previous uterine surgery
  • Pre-eclampsia and the inability to adequately understand the consent form
  • Blocked nose, and any indication patient for whom epidural analgesia is medically indicated (cardiac disease, suspected difficult airway)
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Please refer to this study by its identifier: NCT00801047

Hadassah Medical Organization
Jerusalem, Israel
Sponsors and Collaborators
Hadassah Medical Organization
Principal Investigator: Carolyn F Weiniger, MB ChB Hadassah HMO
  More Information

Responsible Party: Carolyn Weiniger, Hadassah Medical Organization Identifier: NCT00801047     History of Changes
Other Study ID Numbers: rem-epi-nov-2008- HMO-CTIL
Study First Received: December 2, 2008
Last Updated: April 19, 2015
Health Authority: Israel: Ministry of Health, study number 20090125

Keywords provided by Hadassah Medical Organization:

Additional relevant MeSH terms:
Analgesics, Opioid
Anesthetics, General
Anesthetics, Intravenous
Anesthetics, Local
Central Nervous System Agents
Central Nervous System Depressants
Hypnotics and Sedatives
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses processed this record on December 01, 2015