Labor Analgesia With Ropivacaine and Clonidine

Labor Pain Clinical Trial

— LA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00626977
• Other study ID #: upeclin/HC/FMB-Unesp-07
• Status: Completed
• Phase: N/A
• First received: February 20, 2008
• Last updated: July 7, 2015
• Start date: May 2000
• Est. completion date: December 2001

Study information

• Verified date: February 2008
• Source: UPECLIN HC FM Botucatu Unesp
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: December 2001
• Est. primary completion date: May 2000
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Labor Pain

Intervention

Drug:
• ropivacaine
15 ml of ropivacaine 0.125% peridural once
• ropivacaine and clonidine
15 ml of ropivacaine 0.0625% plus 75 mcg clonidine

Locations

Country	Name	City	State
Brazil	College of Medicine of Botucatu	Botucatu	São Paulo

Sponsors (3)

Lead Sponsor	Collaborator
UPECLIN HC FM Botucatu Unesp	Coordenação de Aperfeiçoamento de Pessoal de Nível Superior., Faculdade de Medicina de Botucatu, UNESP, Botucatu, Brasil

Country where clinical trial is conducted

Brazil,