Labor Analgesia With Ropivacaine and Clonidine

NCT ID: NCT00626977

Last Updated: 2015-07-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

32 participants

Study Classification

OBSERVATIONAL

Study Start Date

2000-05-31

Study Completion Date

2001-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Labor Pain

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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R

R group:15 mL of 0.125% ropivacaine (18.75 mg)

ropivacaine

Intervention Type DRUG

15 ml of ropivacaine 0.125% peridural once

RC

RC group:0.0625% ropivacaine (9.375 mg) plus 75 ug clonidine

ropivacaine and clonidine

Intervention Type DRUG

15 ml of ropivacaine 0.0625% plus 75 mcg clonidine

Interventions

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ropivacaine

15 ml of ropivacaine 0.125% peridural once

Intervention Type DRUG

ropivacaine and clonidine

15 ml of ropivacaine 0.0625% plus 75 mcg clonidine

Intervention Type DRUG

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Faculdade de Medicina de Botucatu, UNESP, Botucatu, Brasil

OTHER

Sponsor Role collaborator

Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.

OTHER_GOV

Sponsor Role collaborator

UPECLIN HC FM Botucatu Unesp

OTHER

Sponsor Role lead

Responsible Party

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Yara Marcondes Machado Castiglia

MD PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Giane Nakamura, MD PHd

Role: PRINCIPAL_INVESTIGATOR

College Study of Medicine

Locations

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College of Medicine of Botucatu

Botucatu, São Paulo, Brazil

Site Status

Countries

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Brazil

References

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Nakamura G, Ganem EM, Modolo 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. doi: 10.1590/s1516-31802008000200007.

Reference Type DERIVED
PMID: 18553032 (View on PubMed)

Other Identifiers

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upeclin/HC/FMB-Unesp-07

Identifier Type: -

Identifier Source: org_study_id

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