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Comparative Affect of a Continuous Epidural Infusion of Clonidine During Labour. Prospective Double Blind Randomized Trial

NCT ID: NCT00437996

Last Updated: 2009-06-30

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

PHASE3

Total Enrollment

85 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-02-28

Study Completion Date

2008-01-31

Brief Summary

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Addition of clonidine to an epidural mixture of local anaesthetic and morphine improves analgesia and reduces the frequency of motor blockade during epidural analgesia. several side effects are possible mostly somnolence and hypotension. Association of continuous clonidine infusion with low concentrations of levobupivacaïne and sufentanil was not studied during labour. The objective of this study is to compare the effectiveness and the side effects of a PCEA with levobupivacaïne 0,0625 % and sufentanil 0.25 microg.ml-1, without addition of clonidine, and with addition of clonidine at a concentrations of 2 microg.ml-1.

Detailed Description

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Conditions

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Normal Pregnancy

Keywords

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Labor analgesia - clonidine - epidural

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Interventions

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Clonidine

Intervention Type DRUG

Levobupivacaine

Intervention Type DRUG

Sufentanil

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients of ASA class I or II
* Variable parity
* Aged of 18 years or more
* With a normal pregnancy
* Cervical dilation between 3 and 8 cm)
* Wishing an epidural analgesia
* Normal childbirth
* Giving their written assent
* Affiliated with a social security system
* Must have had an anaesthesia consultation more than 48 hours before inclusion.

Exclusion Criteria

* Request of the patient
* Failure of epidural analgesia
* Childbirth in the 90 minutes following the induction of analgesia
* Realization of a Caesarean section
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Hospices Civils de Lyon

OTHER

Sponsor Role lead

Principal Investigators

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HENRI-JACQUES CLEMENT, MD

Role: PRINCIPAL_INVESTIGATOR

Hospices Civils de Lyon

Locations

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Henri Jacques CLEMENT

Lyon, , France

Site Status

Anesthesie Reanimation - Gynecologie - Hopital de La Croix Rousse

Lyon, , France

Site Status

Countries

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France

References

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Wallet F, Clement HJ, Bouret C, Lopez F, Broisin F, Pignal C, Schoeffler M, Derre E, Charpiat B, Huissoud C, Aubrun F, Viale JP. Effects of a continuous low-dose clonidine epidural regimen on pain, satisfaction and adverse events during labour: a randomized, double-blind, placebo-controlled trial. Eur J Anaesthesiol. 2010 May;27(5):441-7. doi: 10.1097/EJA.0b013e3283365944.

Reference Type DERIVED
PMID: 20299988 (View on PubMed)

Other Identifiers

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2006.424

Identifier Type: -

Identifier Source: org_study_id