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Trial record 57 of 326 for:    clonidine

Systematic Clonidine for Epidural Analgesia in Labour

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ClinicalTrials.gov Identifier: NCT00983125
Recruitment Status : Completed
First Posted : September 23, 2009
Last Update Posted : April 4, 2013
Sponsor:
Information provided by (Responsible Party):
University Hospital, Clermont-Ferrand

Brief Summary:
In a prospective randomised study involving primiparous women in spontaneous uncomplicated labour with cervical dilatation < 5 cm, epidural analgesia will be given with an initial volume of 20 mL anaesthetic solution, followed by a standardised algorithm of top-up manual injections to achieve analgesia, then by a patient-controlled regimen with 5-mL self-administered boli in addition to a continuous infusion of 5 mL.hr-1. The anaesthetic solution will be levobupivacaine presented in 100-mL bags from the market (0.0625%), in which 10 mL (50 g) of sufentanil will be added, as well as clonidine (150 µg) in one arm. The final concentration of clonidine in this arm will be 1.35 mg.mL-1. Parturients and midwifes assessing pain during labour will be blinded to the design.

Condition or disease Intervention/treatment Phase
Labour Drug: Clonidine Phase 4

Detailed Description:
We recently compared the analgesic effects of the two presentations of levobupivacaine available on the French market, (0.625 and 1.25 mg.mL-1 in pre-filled bags), both with sufentanil. It appeared that the high concentration was more powerful, however leading in some cases to give doses of levobupivacaine superior to the label's recommendations. This indicates to use the low concentration, with a risk of a poorer efficacy. Our aim is to show that efficacy can be restored with a systematic addition of clonidine, which has documented analgesic properties when administered perispinally.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 124 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: Effects of a Systematic Addition of Clonidine in the Local Anaesthetic and Opiate Solution for Epidural Patient Controlled Analgesia in Labour (Levobupivacaine 0.568 mg.mLl-1 + Sufentanil 0.45 µg.mL-1)
Study Start Date : August 2009
Actual Primary Completion Date : March 2010
Actual Study Completion Date : March 2010

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Arm Intervention/treatment
Experimental: clonidine Drug: Clonidine

Addition of a non-labeled drug (clonidine) in one of the two arm of the study, with randomisation.

To compare the effects of a systematic addition of clonidine (150 µg added in the solution bag) in the local anesthetic solution), versus no addition, on the quality of analgesia for labour.


no clonidine Drug: Clonidine

Addition of a non-labeled drug (clonidine) in one of the two arm of the study, with randomisation.

To compare the effects of a systematic addition of clonidine (150 µg added in the solution bag) in the local anesthetic solution), versus no addition, on the quality of analgesia for labour.





Primary Outcome Measures :
  1. Number of required additional epidural boluses, either self-administered or medically given as a rescue [ Time Frame: during labour ]

Secondary Outcome Measures :
  1. Spontaneous pain during labour (on VAS) [ Time Frame: during labour ]
  2. Pain at delivery [ Time Frame: at delivery ]
  3. Pain at post-delivery sutures [ Time Frame: at post-delivery sutures ]
  4. Motor block [ Time Frame: during labour ]
  5. Duration of labour [ Time Frame: during labour ]
  6. Obstetrical events (caesarean section, instrumental delivery) [ Time Frame: after delivery ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Parturient is 18 years old
  • ASA physical status 1 or 2
  • Primiparity
  • Singleton
  • Gestational age is 36 weeks
  • Spontaneous labour with cervical dilatation of 5 cm

Information from the National Library of Medicine

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): NCT00983125


Locations
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France
CHU Clermont-Ferrand
Clermont-Ferrand, France, 63003
Sponsors and Collaborators
University Hospital, Clermont-Ferrand
Investigators
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Principal Investigator: Martine Bonnin, MB University Hospital, Clermont-Ferrand

Additional Information:
Publications of Results:
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Responsible Party: University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier: NCT00983125     History of Changes
Other Study ID Numbers: CHU-0058
First Posted: September 23, 2009    Key Record Dates
Last Update Posted: April 4, 2013
Last Verified: April 2013
Keywords provided by University Hospital, Clermont-Ferrand:
Labour
Epidural analgesia
Clonidine
Levobupivacaine
Opiates
Patient-controlled
Active spontaneous labour requiring epidural analgesia
Additional relevant MeSH terms:
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Clonidine
Levobupivacaine
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Local
Sensory System Agents
Peripheral Nervous System Agents
Analgesics
Antihypertensive Agents
Sympatholytics
Autonomic Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action