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...
Date First Received: February 20, 2008
Last Updated: February 28, 2008
Verified by: UPECLIN HC FM Botucatu Unesp, February 2008
Clinical Trial Phase: N/A | Start Date: May 2000
Overall Status: Completed
Estimated Enrollment: 32
Brief Summary
Official Title: “Labor Analgesia With Ropivacaine Added to Clonidine. A Randomized Clinical Trial”
Condition Keyword(s):
Intervention(s):
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 Type: Observational
Study Design: Cohort, Prospective
Study Primary Completion Date: May 2000
Intervention(s) in this Clinical Trial
- Drug: ropivacaine
- 15 ml of ropivacaine 0.125% peridural once
- Drug: ropivacaine and clonidine
- 15 ml of ropivacaine 0.0625% plus 75 mcg clonidine
Arms, Groups and Cohorts in this Clinical Trial
- : R
- R group:15 mL of 0.125% ropivacaine (18.75 mg)
- : RC
- RC group:0.0625% ropivacaine (9.375 mg) plus 75 ug clonidine
Criteria for Participation in this Clinical Trial
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
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: N/A
Maximum Age for this Clinical Trial: N/A
Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers
Clinical Trial Sponsor Information
Lead Sponsor: UPECLIN HC FM Botucatu Unesp
Overall Clinical Trial Officials and Contacts
Giane Nakamura, MD PHd Principal Investigator College Study of Medicine
Additional Information
Information obtained from ClinicalTrials.gov on August 29, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00626977
Study ID Number: upeclin/HC/FMB-Unesp-07
ClinicalTrials.gov Identifier: NCT00626977
Health Authority: Brazil: National Committee of Ethics in Research
Clinical Trials Authorship and Review
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