Labor Analgesia With Ropivacaine and Clonidine (LA)
This study has been completed.
Sponsor:
UPECLIN HC FM Botucatu Unesp
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
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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:
Further study details as provided by 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 |
| 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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00626977
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):
| 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 |
| 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 |
Additional relevant MeSH terms:
|
Labor Pain Pain Neurologic Manifestations Nervous System Diseases Signs and Symptoms Clonidine Ropivacaine Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Antihypertensive Agents |
Sympatholytics Autonomic Agents Adrenergic alpha-2 Receptor Agonists Adrenergic alpha-Agonists Adrenergic Agonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Anesthetics, Local Anesthetics Central Nervous System Depressants |
ClinicalTrials.gov processed this record on September 30, 2016