Labor Analgesia With Ropivacaine and Clonidine (LA)

July 7, 2015 updated by: Yara Marcondes Machado Castiglia, UPECLIN HC FM Botucatu Unesp

Labor Analgesia With Ropivacaine Added to Clonidine. A Randomized Clinical Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

32

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • São Paulo
      • Botucatu, São Paulo, Brazil, 18618970
        • College of Medicine of Botucatu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Women having requested epidural analgesia for labor and hers newborns

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

UPECLIN HC FM Botucatu Unesp

Collaborators

Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
Faculdade de Medicina de Botucatu, UNESP, Botucatu, Brasil

Investigators

  • Principal Investigator: Giane Nakamura, MD PHd, College Study of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2000

Primary Completion (Actual)

May 1, 2000

Study Completion (Actual)

December 1, 2001

Study Registration Dates

First Submitted

February 20, 2008

First Submitted That Met QC Criteria

February 28, 2008

First Posted (Estimate)

February 29, 2008

Study Record Updates

Last Update Posted (Estimate)

July 8, 2015

Last Update Submitted That Met QC Criteria

July 7, 2015

Last Verified

February 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • upeclin/HC/FMB-Unesp-07

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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