- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00626977
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
-
-
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)
|
15 ml of ropivacaine 0.125% peridural once
|
RC
RC group:0.0625%
ropivacaine (9.375 mg) plus 75 ug 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
Collaborators
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.
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
- Pain
- Neurologic Manifestations
- Labor Pain
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Antihypertensive Agents
- Central Nervous System Depressants
- Autonomic Agents
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Anesthetics
- Adrenergic alpha-2 Receptor Agonists
- Adrenergic alpha-Agonists
- Adrenergic Agonists
- Anesthetics, Local
- Sympatholytics
- Ropivacaine
- Clonidine
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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