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

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. Identifier: NCT00801047
Recruitment Status : Completed
First Posted : December 3, 2008
Last Update Posted : April 21, 2015
Information provided by:
Hadassah Medical Organization

Brief Summary:

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 or disease Intervention/treatment Phase
Labor Pain Drug: Bupivacaine epidural Drug: Remifentanil Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison of the Efficacy Intravenous Remifentanil PCA and Epidural PCEA for Labor Analgesia
Study Start Date : February 2010
Actual Primary Completion Date : July 2012
Actual Study Completion Date : July 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Primary analgesia end-point: VAS pain Score [ Time Frame: 1-6 hours ]

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes 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)

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 identifier (NCT number): NCT00801047

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

Responsible Party: Carolyn Weiniger, Hadassah Medical Organization Identifier: NCT00801047     History of Changes
Other Study ID Numbers: rem-epi-nov-2008- HMO-CTIL
First Posted: December 3, 2008    Key Record Dates
Last Update Posted: April 21, 2015
Last Verified: February 2010

Keywords provided by Hadassah Medical Organization:

Additional relevant MeSH terms:
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Analgesics, Opioid
Hypnotics and Sedatives
Anesthetics, Intravenous
Anesthetics, General