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

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ClinicalTrials.gov Identifier: NCT00437996
Recruitment Status : Completed
First Posted : February 21, 2007
Last Update Posted : June 30, 2009
Sponsor:
Information provided by:
Hospices Civils de Lyon

Brief Summary:
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 or disease Intervention/treatment Phase
Normal Pregnancy Drug: Clonidine Drug: Levobupivacaine Drug: Sufentanil Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 85 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Prevention
Official Title: Epidural Analgesia During Labour. Impact of Clonidine Addition to Levobupivacaine and Sufentanil
Study Start Date : February 2007
Actual Study Completion Date : January 2008

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U.S. FDA Resources




Primary Outcome Measures :
  1. 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 :
  1. Motor blockade quantification by a score of modified Bromage specific way.
  2. Labor analgesia.
  3. Circulatory parameters(arterial pressure and heart rate will be noticed at 5 - 10 - 15 - 20 - 30 - 60 minutes and every hour until childbirth).


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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes 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

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00437996


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

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
First Posted: February 21, 2007    Key Record Dates
Last Update Posted: June 30, 2009
Last Verified: June 2009

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

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