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:
UPECLIN HC FM Botucatu Unesp
ClinicalTrials.gov Identifier:
NCT00626977
First received: February 20, 2008
Last updated: February 28, 2008
Last verified: February 2008
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 |
| Estimated 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| 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
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
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
No publications provided by UPECLIN HC FM Botucatu Unesp
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Clinical Research Ethics Committee of College of Medicine of Botucatu, College of Medicine of Botucatu |
| ClinicalTrials.gov Identifier: | NCT00626977 History of Changes |
| Other Study ID Numbers: | upeclin/HC/FMB-Unesp-07 |
| Study First Received: | February 20, 2008 |
| Last Updated: | February 28, 2008 |
| 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:
|
Clonidine Ropivacaine Adrenergic Agents Adrenergic Agonists Adrenergic alpha-2 Receptor Agonists Adrenergic alpha-Agonists Analgesics Anesthetics Anesthetics, Local Antihypertensive Agents Autonomic Agents |
Cardiovascular Agents Central Nervous System Agents Central Nervous System Depressants Molecular Mechanisms of Pharmacological Action Neurotransmitter Agents Peripheral Nervous System Agents Pharmacologic Actions Physiological Effects of Drugs Sensory System Agents Sympatholytics Therapeutic Uses |
ClinicalTrials.gov processed this record on February 27, 2015