Labor Analgesia With Ropivacaine and Clonidine - Full Text View

Labor Analgesia With Ropivacaine and Clonidine (LA)

This study has been completed.

Sponsors and Collaborators:	UPECLIN HC FM Botucatu Unesp 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

MedlinePlus related topics: Anesthesia

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

U.S. FDA Resources

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

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

Biospecimen Retention: None Retained

Biospecimen Description:

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, São Paulo
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

Publications indexed to this study:

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:	College of Medicine of Botucatu ( Clinical Research Ethics Committee of College of Medicine of Botucatu )
Study ID Numbers:	upeclin/HC/FMB-Unesp-07
Study First Received:	February 20, 2008
Last Updated:	February 28, 2008
ClinicalTrials.gov Identifier:	NCT00626977
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

Study placed in the following topic categories:

Signs and Symptoms
Ropivacaine
Clonidine

Labor Pain
Neurologic Manifestations
Pain

Additional relevant MeSH terms:

Sympatholytics
Neurotransmitter Agents
Adrenergic alpha-Agonists
Adrenergic Agents
Molecular Mechanisms of Pharmacological Action
Nervous System Diseases
Physiological Effects of Drugs
Central Nervous System Depressants
Anesthetics
Cardiovascular Agents

Antihypertensive Agents
Anesthetics, Local
Adrenergic Agonists
Pharmacologic Actions
Autonomic Agents
Sensory System Agents
Therapeutic Uses
Analgesics
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 16, 2009