Labor Analgesia With Ropivacaine and Clonidine (LA)

This study has been completed.

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

ClinicalTrials.gov Identifier:

NCT00626977

First received: February 20, 2008

Last updated: July 7, 2015

Last verified: February 2008

History of Changes

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: Clonidine Clonidine hydrochloride Ropivacaine monohydrochloride

U.S. FDA Resources

Further study details as provided by Yara Marcondes Machado Castiglia, UPECLIN HC FM Botucatu Unesp:


Enrollment:	32
Study Start Date:	May 2000
Study Completion Date:	December 2001
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


Ages Eligible for Study:	Child, Adult, Senior
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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:	Yara Marcondes Machado Castiglia, MD PhD, UPECLIN HC FM Botucatu Unesp
ClinicalTrials.gov Identifier:	NCT00626977 History of Changes
Other Study ID Numbers:	upeclin/HC/FMB-Unesp-07
Study First Received:	February 20, 2008
Last Updated:	July 7, 2015

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:


Labor Pain Pain Neurologic Manifestations Nervous System Diseases Signs and Symptoms Ropivacaine Clonidine 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

ClinicalTrials.gov processed this record on June 27, 2017

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