Intravenous Remifentanil Patient-controlled Analgesia (PC... | NCT00801047

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

NCT00801047

Sponsor

Hadassah Medical Organization

Status

Completed

Last Update Posted

Apr 21, 2015Estimated

Enrollment

50Actual

Phase

Phase 4

Conditions

Labor
Pain

Interventions

Bupivacaine epidural
Remifentanil

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2010

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2010

Primary Completion Date

Jul 2012Actual

Completion Date

Jul 2012Actual

First Submitted Date

Dec 2, 2008

First Submission Date that Met QC Criteria

Dec 2, 2008

First Posted Date

Dec 3, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 19, 2015

Last Update Posted Date

Apr 21, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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).

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	Epidural group	Drug: Bupivacaine epidural
2	Active Comparator	Remifentanil iv PCA	Drug: Remifentanil

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Bupivacaine epidural	Drug	Bupivacaine 0.1%, fentanyl 1 mic/kg	1
Remifentanil

Measure	Description	Time Frame
Primary analgesia end-point: VAS pain Score		1-6 hours

Eligibility Module

Eligibility 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)

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Carolyn F Weiniger, MB ChB	Hadassah HMO	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hadassah Medical Organization		Jerusalem			Israel

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
18617388	Background	Hill D. Remifentanil patient-controlled analgesia should be routinely available for use in labour. Int J Obstet Anesth. 2008 Oct;17(4):336-9. doi: 10.1016/j.ijoa.2008.03.005. No abstract available.

ID	Term
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

ID	Term
D011422	Propionates
D000144	Acids, Acyclic
D002264	Carboxylic Acids
D009930	Organic Chemicals