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

This study has been completed.
Information provided by:
Hospices Civils de Lyon Identifier:
First received: February 19, 2007
Last updated: June 26, 2009
Last verified: June 2009

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, without addition of clonidine, and with addition of clonidine at a concentrations of 2

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:

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

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

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
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Please refer to this study by its identifier: NCT00437996

Anesthesie Reanimation - Gynecologie - Hopital de La Croix Rousse
Lyon, France, 69004
Henri Jacques CLEMENT
Lyon, France, 69000
Sponsors and Collaborators
Hospices Civils de Lyon
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 Identifier (NCT Number): 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:
Adjuvants, Anesthesia
Adrenergic Agents
Adrenergic Agonists
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Analgesics, Opioid
Anesthetics, General
Anesthetics, Intravenous
Anesthetics, Local
Antihypertensive Agents
Autonomic Agents
Cardiovascular Agents
Central Nervous System Agents
Central Nervous System Depressants
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses processed this record on October 21, 2014