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

This study has been completed.
Sponsor:
Information provided by:
Hospices Civils de Lyon
ClinicalTrials.gov Identifier:
NCT00437996
First received: February 19, 2007
Last updated: June 26, 2009
Last verified: June 2009
History of Changes
  Purpose

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.


Condition Intervention Phase
Normal Pregnancy
 Drug: Clonidine
Drug: Levobupivacaine
Drug: Sufentanil
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
Official Title: Epidural Analgesia During Labour. Impact of Clonidine Addition to Levobupivacaine and Sufentanil

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hospices Civils de Lyon:

Primary Outcome Measures:
  • Score of quality at the time of the childbirth based on a 4-point scale : motor blockade - no sensation - nonpainful sensation - pain.

Secondary Outcome Measures:
  • Motor blockade quantification by a score of modified Bromage specific way.
  • Labor analgesia.
  • Circulatory parameters(arterial pressure and heart rate will be noticed at 5 - 10 - 15 - 20 - 30 - 60 minutes and every hour until childbirth).

Enrollment: 85
Study Start Date: February 2007
Study Completion Date: January 2008
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00437996

Locations
France
Anesthesie Reanimation - Gynecologie - Hopital de La Croix Rousse
Lyon, France, 69004
Henri Jacques CLEMENT
Lyon, France, 69000
Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
Principal Investigator: HENRI-JACQUES CLEMENT, MD Hospices Civils de Lyon
  More Information

No publications provided by Hospices Civils de Lyon

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

ClinicalTrials.gov Identifier: NCT00437996     History of Changes
Other Study ID Numbers: 2006.424
Study First Received: February 19, 2007
Last Updated: June 26, 2009
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Hospices Civils de Lyon:
Labor analgesia - clonidine - epidural

Additional relevant MeSH terms:
Clonidine
Sufentanil
Levobupivacaine
Bupivacaine
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Sympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
 Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Analgesics
Sensory System Agents
Central Nervous System Agents
Analgesics, Opioid
Central Nervous System Depressants
Adjuvants, Anesthesia
Narcotics
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Anesthetics, Local

ClinicalTrials.gov processed this record on May 21, 2013