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Labor Analgesia With Ropivacaine and Clonidine (LA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00626977
Recruitment Status : Completed
First Posted : February 29, 2008
Last Update Posted : July 8, 2015
Sponsor:
Collaborators:
Faculdade de Medicina de Botucatu, UNESP, Botucatu, Brasil
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
Information provided by (Responsible Party):
Yara Marcondes Machado Castiglia, UPECLIN HC FM Botucatu Unesp

Study Description
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Brief Summary:
The aim of the present study was to examine, for pain relief during labor, the efficacy of two pharmacological approaches - the 0.125% ropivacaine alone and the 0.0625% ropivacaine added to 75 ug clonidine, both by epidural administration. The effect of the drugs on mother and newborn was also determined.

Condition or disease Intervention/treatment
Labor Pain Drug: ropivacaine Drug: ropivacaine and clonidine

Study Design
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Study Type : Observational
Actual Enrollment : 32 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Labor Analgesia With Ropivacaine Added to Clonidine. A Randomized Clinical Trial
Study Start Date : May 2000
Actual Primary Completion Date : May 2000
Actual Study Completion Date : December 2001

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Groups and Cohorts
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Group/Cohort Intervention/treatment
R
R group:15 mL of 0.125% ropivacaine (18.75 mg)
 Drug: ropivacaine
15 ml of ropivacaine 0.125% peridural once
RC
RC group:0.0625% ropivacaine (9.375 mg) plus 75 ug clonidine
 Drug: ropivacaine and clonidine
15 ml of ropivacaine 0.0625% plus 75 mcg clonidine


Outcome Measures
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Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Women having requested epidural analgesia for labor and hers newborns
Criteria

Inclusion Criteria:

  • Singleton healthy
  • Full-term pregnancy
  • American Society of Anesthesiologists physical status I or II

Exclusion Criteria:

  • Patients who had received opioids
  • History of hypersensitivity to local anesthetic or to clonidine
  • Fetus showed signs of possible intrauterine suffering
  • Fetus showed signs of possible neurological deficit
Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00626977


Locations
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Brazil
College of Medicine of Botucatu
Botucatu, São Paulo, Brazil, 18618970
Sponsors and Collaborators
UPECLIN HC FM Botucatu Unesp
Faculdade de Medicina de Botucatu, UNESP, Botucatu, Brasil
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
Investigators
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Principal Investigator: Giane Nakamura, MD PHd College Study of Medicine
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Yara Marcondes Machado Castiglia, MD PhD, UPECLIN HC FM Botucatu Unesp
ClinicalTrials.gov Identifier: NCT00626977    
Other Study ID Numbers: upeclin/HC/FMB-Unesp-07
First Posted: February 29, 2008    Key Record Dates
Last Update Posted: July 8, 2015
Last Verified: February 2008
Keywords provided by Yara Marcondes Machado Castiglia, UPECLIN HC FM Botucatu Unesp:
Analgesia
Obstetrical
Anesthesia
Epidural
Newborn
 Anesthetics, local
Clonidine
Pregnant women
Infant, newborn
Additional relevant MeSH terms:
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Labor Pain
Pain
Neurologic Manifestations
Clonidine
Ropivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
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