Comparison of the Efficacy Intravenous Remifentanil Patient-Controlled Analgesia (PCA) and Epidural Patient Controlled Epidural Analgesia (PCEA) for Labor Analgesia

This study is not yet open for participant recruitment.

Verified by Hadassah Medical Organization, December 2008

First Received: December 2, 2008 No Changes Posted

Sponsored by:	Hadassah Medical Organization
Information provided by:	Hadassah Medical Organization
ClinicalTrials.gov Identifier:	NCT00801047

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 IV

Drug Information available for: Bupivacaine hydrochloride Bupivacaine Remifentanil hydrochloride Remifentanil

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	Comparison of the Efficacy Intravenous Remifentanil PCA and Epidural PCEA for Labor Analgesia

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:	July 2009
Estimated Study Completion Date:	December 2011
Estimated Primary Completion Date:	December 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Epidural group	Drug: Bupivacaine epidural Bupivacaine 0.1%, fentanyl 1 mic/kg
2: Active Comparator 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

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
Jerusalem, Israel

Sponsors and Collaborators

Hadassah Medical Organization

Investigators

Principal Investigator:

Carolyn F Weiniger, MB ChB

Hadassah HMO

More Information

Publications:

Hill D. Remifentanil patient-controlled analgesia should be routinely available for use in labour. Int J Obstet Anesth. 2008 Oct;17(4):336-9. No abstract available.

Responsible Party:	Hadassah Medical Organization ( Carolyn Weiniger )
Study ID Numbers:	rem-epi-nov-2008
Study First Received:	December 2, 2008
Last Updated:	December 2, 2008
ClinicalTrials.gov Identifier:	NCT00801047 History of Changes
Health Authority:	Israel: Ministry of Health

Keywords provided by Hadassah Medical Organization:

Epidural
Labor
Remifentanil

Study placed in the following topic categories:

Anesthetics, Intravenous
Fentanyl
Remifentanil
Anesthetics
Central Nervous System Depressants
Pain
Anesthetics, Local

Anesthetics, General
Hypnotics and Sedatives
Bupivacaine
Peripheral Nervous System Agents
Analgesics
Analgesics, Opioid

Additional relevant MeSH terms:

Anesthetics, Intravenous
Remifentanil
Physiological Effects of Drugs
Anesthetics
Central Nervous System Depressants
Anesthetics, Local
Pharmacologic Actions
Anesthetics, General

Sensory System Agents
Therapeutic Uses
Hypnotics and Sedatives
Bupivacaine
Peripheral Nervous System Agents
Analgesics
Central Nervous System Agents
Analgesics, Opioid

ClinicalTrials.gov processed this record on May 07, 2009