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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2010 by Hadassah Medical Organization.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT00801047
First received: December 2, 2008
Last updated: June 22, 2011
Last verified: February 2010
  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
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 ]

Estimated Enrollment: 50
Study Start Date: February 2010
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: December 2011 (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

Ages Eligible for Study:   18 Years to 40 Years
Genders 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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00801047

Contacts
Contact: Carolyn F Weiniger, MB ChB 00972507874059 carolynfweinger@gmail.com

Locations
Israel
Hadassah Medical Organization Recruiting
Jerusalem, Israel
Contact: Arik Tzukert, PhD    0097226777242    arik@hadassah.org.il   
Principal Investigator: Carolyn F Weiniger, MB ChB         
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
Study First Received: December 2, 2008
Last Updated: June 22, 2011
Health Authority: Israel: Ministry of Health, study number 20090125

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
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Analgesics, Opioid
Narcotics
Analgesics
Hypnotics and Sedatives
Anesthetics, Intravenous
Anesthetics, General

ClinicalTrials.gov processed this record on September 16, 2014