NCT00626977

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2000

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2000

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2000

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2001

Completed
6.2 years until next milestone

First Submitted

Initial submission to the registry

February 20, 2008

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 29, 2008

Completed
Last Updated

July 8, 2015

Status Verified

February 1, 2008

Enrollment Period

Same day

First QC Date

February 20, 2008

Last Update Submit

July 7, 2015

Conditions

Labor Pain

Keywords

AnalgesiaObstetricalAnesthesiaEpiduralNewbornAnesthetics, localClonidinePregnant womenInfant, newborn

Study Arms (2)

R

R group:15 mL of 0.125% ropivacaine (18.75 mg)

Drug: ropivacaine

RC

RC group:0.0625% ropivacaine (9.375 mg) plus 75 ug clonidine

Drug: ropivacaine and clonidine

Interventions

ropivacaineDRUG

15 ml of ropivacaine 0.125% peridural once

R
ropivacaine and clonidineDRUG

15 ml of ropivacaine 0.0625% plus 75 mcg clonidine

RC

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Women having requested epidural analgesia for labor and hers newborns

You may qualify if:

  • Singleton healthy
  • Full-term pregnancy
  • American Society of Anesthesiologists physical status I or II

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

College of Medicine of Botucatu

Botucatu, São Paulo, 18618970, Brazil

Location

Related Publications (1)

  • Nakamura G, Ganem EM, Modolo NS, Rugolo LM, Castiglia YM. Labor analgesia with ropivacaine added to clonidine: a randomized clinical trial. Sao Paulo Med J. 2008 Mar 6;126(2):102-6. doi: 10.1590/s1516-31802008000200007.

    PMID: 18553032DERIVED

MeSH Terms

Conditions

Labor PainAgnosia

Interventions

RopivacaineClonidine

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPerceptual DisordersNeurobehavioral ManifestationsNervous System Diseases

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAminesImidazolinesImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Giane Nakamura, MD PHd

    College Study of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD PhD

Study Record Dates

First Submitted

February 20, 2008

First Posted

February 29, 2008

Study Start

May 1, 2000

Primary Completion

May 1, 2000

Study Completion

December 1, 2001

Last Updated

July 8, 2015

Record last verified: 2008-02

Locations

BR(1)