We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00801047
First Posted: December 3, 2008
Last Update Posted: April 21, 2015
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.
Information provided by:
Hadassah Medical Organization
  Purpose

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
Labor Pain Drug: Bupivacaine epidural Drug: Remifentanil Phase 4

Study Type: Interventional
Study Design: 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

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 ]

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

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00801047


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

Publications:
Responsible Party: Carolyn Weiniger, Hadassah Medical Organization
ClinicalTrials.gov Identifier: NCT00801047     History of Changes
Other Study ID Numbers: rem-epi-nov-2008- HMO-CTIL
First Submitted: December 2, 2008
First Posted: December 3, 2008
Last Update Posted: April 21, 2015
Last Verified: February 2010

Keywords provided by Hadassah Medical Organization:
Epidural
Labor
Remifentanil

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