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

NCT ID: NCT00801047

Last Updated: 2015-04-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-02-28

Study Completion Date

2012-07-31

Brief Summary

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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

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Conditions

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Labor Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Epidural group

Group Type EXPERIMENTAL

Bupivacaine epidural

Intervention Type DRUG

Bupivacaine 0.1%, fentanyl 1 mic/kg

2

Remifentanil iv PCA

Group Type ACTIVE_COMPARATOR

Remifentanil

Intervention Type DRUG

40-50 mic per 1-2 min via PCA

Interventions

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Bupivacaine epidural

Bupivacaine 0.1%, fentanyl 1 mic/kg

Intervention Type DRUG

Remifentanil

40-50 mic per 1-2 min via PCA

Intervention Type DRUG

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Hadassah Medical Organization

OTHER

Sponsor Role lead

Responsible Party

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Hadassah Medical Organization

Principal Investigators

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Carolyn F Weiniger, MB ChB

Role: PRINCIPAL_INVESTIGATOR

Hadassah HMO

Locations

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Hadassah Medical Organization

Jerusalem, , Israel

Site Status

Countries

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Israel

References

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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.

Reference Type BACKGROUND
PMID: 18617388 (View on PubMed)

Other Identifiers

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rem-epi-nov-2008- HMO-CTIL

Identifier Type: -

Identifier Source: org_study_id

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