Labor Analgesia With Ropivacaine and Clonidine - Full Text View

Labor Analgesia With Ropivacaine and Clonidine (LA)

This study has been completed.

First Received on February 20, 2008. Last Updated on February 28, 2008 History of Changes

Sponsor:	UPECLIN HC FM Botucatu Unesp
Collaborators:	Faculdade de Medicina de Botucatu, UNESP, Botucatu, Brasil Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
Information provided by:	UPECLIN HC FM Botucatu Unesp
ClinicalTrials.gov Identifier:	NCT00626977

Purpose

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	Intervention
Labor Pain	Drug: ropivacaine Drug: ropivacaine and clonidine

Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Prospective
Official Title:	Labor Analgesia With Ropivacaine Added to Clonidine. A Randomized Clinical Trial

Resource links provided by NLM:

Drug Information available for: Ropivacaine Ropivacaine monohydrochloride Ropivacaine Hydrochloride Clonidine Clonidine hydrochloride

U.S. FDA Resources

Further study details as provided by UPECLIN HC FM Botucatu Unesp:

Enrollment:	32
Study Start Date:	May 2000
Study Completion Date:	December 2001
Estimated Primary Completion Date:	May 2000 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
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

Eligibility

Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00626977

Locations

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

Principal Investigator:

Giane Nakamura, MD PHd

College Study of Medicine

More Information

No publications provided by UPECLIN HC FM Botucatu Unesp

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

Nakamura G, Ganem EM, Módolo NS, Rugolo LM, Castiglia YM. Labor analgesia with ropivacaine added to clonidine: a randomized clinical trial. Sao Paulo Med J. 2008 Mar 6;126(2):102-6.

Responsible Party:	Clinical Research Ethics Committee of College of Medicine of Botucatu, College of Medicine of Botucatu
ClinicalTrials.gov Identifier:	NCT00626977 History of Changes
Other Study ID Numbers:	upeclin/HC/FMB-Unesp-07
Study First Received:	February 20, 2008
Last Updated:	February 28, 2008
Health Authority:	Brazil: National Committee of Ethics in Research

Keywords provided by UPECLIN HC FM Botucatu Unesp:

Analgesia
Obstetrical
Anesthesia
Epidural
Newborn

Anesthetics, local
Clonidine
Pregnant women
Infant, newborn

Additional relevant MeSH terms:

Labor Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Clonidine
Ropivacaine
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
Anesthetics, Local
Anesthetics
Central Nervous System Depressants

ClinicalTrials.gov processed this record on February 09, 2012